🕷️ Crawler Inspector

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Raw Queries and Responses

1. Shard Calculation

Query:

Response:

Calculated Shard: 152 (from laksa019)

2. Crawled Status Check

Query:

curl -X POST \
  'http://laksa152.int.ahrefs:8124/' \
  -H 'Content-Type: text/plain' \
  -H 'X-ClickHouse-Database: crawler3' \
  -H 'Authorization: Basic YXBpOg==' \
  -d 'SELECT getAhrefsURLFromUnparsed(src_unparsed) AS found_url, ifNull(toUnixTimestamp(download_stamp), 0) AS crawl_time, ifNull(toUnixTimestamp(props_url_first_seen), 0) AS first_indexed_time, download_http_code AS http_code, src_unparsed AS src_unparsed, src_root_hash AS src_root_hash, history_drop_reason AS history_drop_reason, meta_title AS meta_title, meta_descriptions AS meta_descriptions, attrs_boilerpipe_text AS attrs_boilerpipe_text, attrs_markdown AS attrs_markdown, attrs_readable_markdown AS attrs_readable_markdown, meta_canonical AS meta_canonical FROM crawler3.page_info_local FINAL PREWHERE (src_root_hash, src_unparsed) IN ((getAhrefsRootHashFromUnparsed(getAhrefsUnparsedNoserviceFromURL(\'https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test\')), getAhrefsUnparsedNoserviceFromURL(\'https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test\'))) FORMAT JSONEachRow'

Response:

{"found_url":"https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test","crawl_time":1774222757,"first_indexed_time":1621600651,"http_code":200,"src_unparsed":"org,wikipedia!en,\/wiki\/COVID-19_rapid_antigen_test s443","src_root_hash":"17790707453426894952","history_drop_reason":null,"meta_title":"COVID-19 rapid antigen test - Wikipedia","meta_descriptions":[],"attrs_boilerpipe_text":"From Wikipedia, the free encyclopedia\nCOVID-19 rapid antigen test\nNegative (left, showing Control line) and positive (right, showing Control and Test lines) results\nSynonyms\nSARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test\n[\na\n]\nPurpose\nTo diagnose\nSARS-CoV-2\ninfections (\nCOVID-19\n)\nLOINC\n94558-4\n,\n95209-3\n,\n96119-3\n,\n97097-0\nCOVID-19 rapid antigen tests\nor\nRAT\ns, also frequently called\nCOVID-19\nlateral flow tests\nor\nLFT\ns, are\nrapid antigen tests\nused to detect\nSARS-CoV-2\ninfection (\nCOVID-19\n). They are quick to implement with minimal training, cost a fraction of other forms of\nCOVID-19 testing\n, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.\n[\n1\n]\nMany RATs can be used for self-testing, in which an individual \"collects their own specimen… and interpret[s] their test result themselves\".\n[\n2\n]\nFalse positives\nare very rare; the tests'\nspecificity\nis 98%-99%.\n[\n3\n]\n[\n4\n]\n[\n5\n]\nHowever, the tests have a\nsensitivity\nof 70%-72%,\n[\n3\n]\n[\n4\n]\n[\n5\n]\nwhich is lower than COVID-19\npolymerase chain reaction\n(PCR) tests' sensitivity of 88%-96%.\n[\n6\n]\n[\n7\n]\n[\nb\n]\nDespite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the\nviral load\nis higher.\n[\n3\n]\n[\n4\n]\n[\n5\n]\n[\n8\n]\n[\n9\n]\nCOVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The\nWorld Health Organization\n(WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a \"confirmed case of SARS-CoV-2 infection\" in two ways.\n[\n10\n]\nFirst, the person with a positive Antigen-RDT could meet a \"probable case definition\" such as having recent loss of smell or taste without any known cause, or could meet certain \"suspect criteria\" such as having a severe acute respiratory illness.\n[\n10\n]\nSecond, the person with a positive Antigen-RDT could be asymptomatic but a \"contact of a probable or confirmed case.\"\n[\n10\n]\nNevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a \"confirmed case.\"\n[\n11\n]\nBetween 2020 and 2021, studies using\nmathematical models\nestimated the benefit of frequent RATs in\nscreening\npopulations for COVID-19. Paltiel\net al\nstudied a hypothetical college campus with 5000 students.\n[\n12\n]\nScreening all students every two days with a \"low-sensitivity, high-specificity test\" (such as a RAT) would be able to control an outbreak of COVID-19.\n[\n12\n]\nMina\net al\ntheorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would \"capture most infections while they are still infectious.\"\n[\n13\n]\nThe quick results of RATs would serve to limit asymptomatic spread.\n[\n13\n]\nLarremore\net al\nsimulated various COVID-19 population screening strategies.\n[\n14\n]\nThe researchers found that \"effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity.\"\n[\n14\n]\nIn addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.\n[\n15\n]\nFurthermore, following the closure of national borders in Europe following the emergence of the\nAlpha variant\njust before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,\n[\n16\n]\neffectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.\n[\n17\n]\n[\n18\n]\nMédecins Sans Frontières\nstrongly endorsed the use of rapid tests in lower- and middle-income countries, noting \"COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level\".\n[\n19\n]\nUse for \"return to normal\"\n[\nedit\n]\nSpain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,\n[\n20\n]\nand a free music concert held in\nBarcelona\nfor individuals who took a rapid test.\n[\n21\n]\nA similar approach was taken in\nAlbania\nto enable music festivals.\n[\n22\n]\nHowever, many experts were unsure of this approach believing that \"rapid tests are not the solution to restart normal life\"\n[\n23\n]\nbut might be used in conjunction with other infection control techniques.\n[\n24\n]\nA certification of quality for a COVID-19 rapid antigen home test.\nFalse negatives (low sensitivity)\n[\nedit\n]\nAlthough the\nspecificity\nof RATs are high (98%-99%),\n[\n3\n]\n[\n4\n]\n[\n5\n]\nin 2020 RATs were criticized for having a\nsensitivity\nas low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.\n[\n25\n]\n[\n26\n]\n[\n27\n]\nAs of 2022,\nsystematic reviews\ndetermined that the pooled sensitivities of RATs were 70%-72%.\n[\n3\n]\n[\n4\n]\n[\n5\n]\nIn one systematic review, the range of sensitivities across studies was 37%-90%.\n[\n3\n]\nAs the\nWorld Health Organization\n(WHO) recommends RATs with \"≥ 80% sensitivity\",\n[\n28\n]\nmany RATs do not meet the WHO recommendation.\nIn the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).\n[\n3\n]\n[\n4\n]\n[\n5\n]\nRATs were more sensitive when samples had more viral load, as measured by a low PCR \"cycle threshold,\" and less sensitive when the samples had less viral load.\n[\n3\n]\n[\n4\n]\n[\n5\n]\nA 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.\n[\n29\n]\nIt found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.\n[\n29\n]\nCompared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.\n[\n29\n]\nThe sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.\n[\n29\n]\nPotential for false negative results due to new variants\n[\nedit\n]\nIn November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the\nSARS-CoV-2 Alpha variant\n. The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours\nPublic Health England\nlaboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the\ncapsid\nprotein and not the\nspike protein\n.\n[\n30\n]\nSome strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.\n[\n31\n]\nFortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.\n[\n31\n]\nA study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the\nDelta variant\nand 69.6%-78.3% for the\nOmicron variant\nacross a range of\nviral loads\n; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.\n[\n32\n]\nFalse positive results when instructions not followed\n[\nedit\n]\nIf a COVID-19 RAT is used outside manufacturer recommendations, the result can be\nfalse positive\n. Beginning in December 2020,\nTikTok\nvideos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.\n[\n33\n]\nLater, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended\nbuffer solution\nproduced false positives.\n[\n34\n]\nIn contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.\n[\n34\n]\nSlow deployment and uptake\n[\nedit\n]\nSome have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.\n[\n35\n]\nToxicity of components\n[\nedit\n]\nVarious concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.\n[\n36\n]\nOn 24 February 2022,\nHealth Canada\nissued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives\n[\n37\n]\nsodium azide\nand ProClin.\n[\n38\n]\nAn\nantigen\nis a foreign\nmolecule\nor molecular\nstructure\nthat can cause an\nimmune response\n. COVID-19 rapid antigen tests (RATs) detect antigenic\nproteins\non the surface of or in the interior of the SARS-CoV-2\ncoronavirus\n. Of the COVID-19 RATs that had received an\nemergency use authorization\n(EUA) from the US\nFood and Drug Administration\n(FDA) by January 2022, all detected\nnucleocapsid\nproteins, and one also detected the receptor-binding domain of the\ncoronavirus spike protein\n.\n[\n39\n]\n: Table S1 \nSimilarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.\n[\n40\n]\nRapid antigen test functioning by\nlateral flow assay\n.\nA typical COVID-19 RAT is a\nlateral flow test\n(LFT).\n[\n39\n]\n: Table S1 \n[\n41\n]\nFor an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.\n[\n42\n]\n[\n43\n]\nThe liquid is pulled through the strip by wicking (\ncapillary action\n), encountering different chemically-enhanced regions embedded within the strip.\nFirst, at a \"conjugate pad,\" soluble antibodies with gold\nnanoparticles\nare picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample.\n[\n41\n]\nThen, at the test line (which may be labelled \"T\"),\nantibodies\nspecific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles.\n[\n41\n]\nFinally at the control line (which may be labelled \"C\"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles.\n[\n41\n]\nIf there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test.\n[\n41\n]\n[\n42\n]\n[\n43\n]\nHistory of development and deployment\n[\nedit\n]\nCOVID-19 rapid test being administered in Rwanda\nIn May 2020, the US\nFood and Drug Administration\n(FDA) issued the first\nemergency use authorization\n(EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by\nQuidel\n.\n[\n44\n]\nIn August 2020, the\nUnited States Department of Health and Human Services\nannounced that the US government would be purchasing 150 million BinaxNOW RATs produced by\nAbbott Laboratories\n\"to expand strategic, evidence-based testing.\"\n[\n45\n]\nLater the agency announced that 100 million of the tests were to be sent to governors to use \"at their discretion,\" for example to reopen schools.\n[\n46\n]\nBy September 2020, it was reported that the United Kingdom's\nMoonshot program\nwould be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.\n[\n47\n]\nIn that month, the\nWorld Health Organization\n(WHO) released interim guidance on COVID-19 \"antigen-detecting rapid diagnostic tests\" (Ag-RDTs) including recommendations for their use, selection, and implementation.\n[\n48\n]\nThe interim guidance noted that Ag-RDTs were easier to implement and less expensive than\nnucleic acid\namplification tests (NAATs).\n[\n48\n]\nThe\nWorld Health Organization\n(WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.\n[\n48\n]\nHealth Canada\napproved its first COVID-19 RAT in October 2020, the Abbott Panbio test.\n[\n49\n]\nAs of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.\n[\n50\n]\n[\n51\n]\nRATs began to be rolled out across Portuguese schools and care homes.\n[\n52\n]\nOne of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by\nPublic Health England\nand\nUniversity of Oxford\n, with a preliminary report released in November 2020.\n[\n53\n]\nThe researchers undertook an evaluation of 64 LFDs that proceeded in several phases.\n[\n54\n]\nOf the four LFDs with \"desirable performance characteristics,\" one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.\n[\n54\n]\nContents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system.\nOn 2 November 2020,\nSlovakia\nbecame the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD\nBiosensor\nantigen test and performed swabbing on the population.\n[\n55\n]\n[\n56\n]\nTwo research studies on the Slovakia experience were published in early 2021, one by professor\nMartin Kahanec\nfrom\nCentral European University\nand his coauthors and another one by Martin Pavelka from the\nLondon School of Hygiene & Tropical Medicine\nand his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.\n[\n1\n]\n[\n57\n]\nThe United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the\nPrime Minister\n,\nBoris Johnson\n, started city-wide screening of\nLiverpool\nas part of the accelerated technology evaluation.\n[\n58\n]\n[\n59\n]\nFurther expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at\nDurham University\n, who had the infrastructure and expertise to manage the rapid test programme,\n[\n60\n]\nbut was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.\n[\n61\n]\nRapid tests were also implemented within the\nNational Health Service\n(NHS) for staff to reduce possible transmission to patients,\n[\n62\n]\nlocal authorities\n[\n63\n]\nand care homes to enable visits to visit residents.\n[\n64\n]\n[\n65\n]\nOn 18 November 2020,\nWales\ncompleted the first whole borough testing at\nMerthyr Tydfil\n.\n[\n66\n]\n[\n67\n]\nGlobal efforts to step up evaluations of rapid tests were initiated by the\nWorld Health Organization\n(WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the\nBill and Melinda Gates Foundation\nthat limited costs for low- and middle-income countries.\n[\n68\n]\n[\n69\n]\nAustria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).\n[\n70\n]\n[\n71\n]\nBy the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,\n[\n72\n]\nthe United Kingdom,\n[\n73\n]\nand the US.\n[\n74\n]\nThese studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,\n[\n75\n]\ntravel hubs in Indonesia,\n[\n76\n]\nand across India.\n[\n77\n]\nProfessor\nWilliam A. Haseltine\nof Harvard said that \"rapid, self-administered testing could stem the ever-surging tide of disease and death.\"\n[\n78\n]\nHowever, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the $900 billion in COVID-19 relief contained within the\nConsolidated Appropriations Act, 2021\n. The bill was criticized for not specifically supporting COVID rapid self-tests.\n[\n79\n]\nMeanwhile, the FDA authorized the Abbott BinaxNOW RAT \"for prescription use at home.\"\n[\n80\n]\n[\n81\n]\nSubsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.\n[\n82\n]\nIn the UK in December 2020, the\nMedicines and Healthcare products Regulatory Agency\napproved the Innova rapid test for self-testing of asymptomatic people.\n[\n83\n]\nThe United Kingdom's chief clinical medic, Dr\nSusan Hopkins\n, noted that rapid tests provided a means to find \"people that...we couldn't otherwise find\".\n[\n84\n]\nNoting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the\nEuropean Commission\n(EC) met in December 2020 and developed a common European framework for \"use, validation and mutual recognition of rapid tests\", committing 100 million euros for the purchase of tests from\nRoche\nand\nAbbott\n.\n[\n85\n]\nStella Kyriakides\n, commissioner for Health and Food Safety, said \"Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic.\"\n[\n85\n]\nBy January 2021, the\nCouncil of the European Union\nadvocated greater use of rapid tests, noting that \"should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered.\"\n[\n86\n]\nIn the US, newly inaugurated US president\nJoe Biden\nreleased a national strategy for COVID-19 that pledged to \"fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available.\"\n[\n87\n]\nIn March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.\n[\n88\n]\nInnova voluntarily launched a\nClass I recall\nin the US of more than 77,000 of its RATs in April 2021.\n[\n89\n]\nTwo months later, the FDA warned Americans to stop using the test because it had \"significant concerns that the performance of the test has not been adequately established.\"\n[\n89\n]\nA week after the FDA's warning about the Innova test, UK's\nMedicines and Healthcare products Regulatory Agency\n(MHRA) cleared the rapid diagnostic's use and extended its authorization.\n[\n90\n]\nIn October 2021, the\nWorld Health Organization\n(WHO) updated its interim guidance on Ag-RDTs.\n[\n28\n]\nAmong other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.\n[\n28\n]\nAlso in October 2021, Ellume recalled more than 2.2 million of its home tests because of \"higher-than-acceptable false positive test results for SARS-CoV-2\".\n[\n91\n]\nIn December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.\n[\n92\n]\nIn response, Dr\nLeana Wen\nwas quoted as saying that the number of tests \"does not come even close to what's needed.\"\n[\n92\n]\nUS president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.\n[\n93\n]\nIn March 2022, the\nWorld Health Organization\n(WHO) issued interim guidance on self-testing with Ag-RDTs.\n[\n2\n]\nThe WHO made a strong recommendation that COVID-19 Ag-RDT self-testing \"should be offered in addition to professionally administered testing services.\"\n[\n2\n]\nAn April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.\n[\n94\n]\nIn October 2024, the US\nFood and Drug Administration\ngranted marketing authorization for the Healgen Rapid Check COVID-19\/Flu A&B Antigen Test.\n[\n95\n]\nThe test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).\n[\n95\n]\nThe test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).\n[\n95\n]\nThis is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.\n[\n95\n]\nOther OTC flu\/COVID tests are available under emergency use authorization.\n[\n95\n]\nCosts and cost-effectiveness\n[\nedit\n]\nIn late 2020, it was noted that in the US RATs cost\nUS$\n5-$23, in contrast with PCR tests which cost at least $75.\n[\n50\n]\nIn a Danish study published in 2021, RATs cost about $5.70 per test, as opposed to PCRs at $10.80 per test.\n[\n96\n]\nA 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.\n[\n97\n]\nA 2021 study concluded that if the US is willing to pay $100,000 per\nyear of life lost\naverted, then weekly or monthly testing of the population using RATs is likely to be\ncost-effective\n.\n[\n98\n]\nAnother 2021 study estimated\nincremental cost-effectiveness ratios\nof \"$7890 per infection averted and $1 430 000 per death averted\" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.\n[\n99\n]\nGlobal market value\n[\nedit\n]\nEstimates of value of the worldwide market for RATs vary. One estimate was that the market size was $28 billion in 2021 with a\ncompound annual growth rate\n(CAGR) of -21.7%, leading to a size of $14 billion in 2028.\n[\n100\n]\nA second estimate suggested that the market value was $4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of $743 million in 2027.\n[\n101\n]\nA third estimate found a value of $5.3 billion in 2020, which was \"anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027.\"\n[\n102\n]\n^\n\"Point of care test\" and \"rapid test\" could refer to \"rapid antigen test\" but could also refer to tests that use PCR or other technologies.\n^\nThe study by Pecoraro\net al\nfound a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88.\n^\na\nb\n^\na\nb\nc\nUse of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report).\nWorld Health Organization\n(WHO). 9 March 2022.\nhdl\n:\n10665\/352350\n. WHO\/2019-nCoV\/Ag-RDTs\/Self_testing\/2022.1.\n^\na\nb\nc\nd\ne\nf\ng\nh\nKhalid MF, Selvam K, Jeffry AJ, Salmi MF, Najib MA, Norhayati MN, et al. (4 January 2022).\n\"Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis\"\n.\nDiagnostics\n.\n12\n(1): 110.\ndoi\n:\n10.3390\/diagnostics12010110\n.\nPMC\n \n8774565\n.\nPMID\n \n35054277\n.\n^\na\nb\nc\nd\ne\nf\ng\nBrümmer LE, Katzenschlager S, McGrath S, Schmitz S, Gaeddert M, Erdmann C, et al. (26 May 2022).\n\"Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors\"\n.\nPLOS Med\n.\n19\n(5) e1004011.\ndoi\n:\n10.1371\/journal.pmed.1004011\n.\nPMC\n \n9187092\n.\nPMID\n \n35617375\n.\n^\na\nb\nc\nd\ne\nf\ng\nTapari A, Braliou GG, Papaefthimiou M, Mavriki H, Kontou PI, Nikolopoulos GK, et al. (4 June 2022).\n\"Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis\"\n.\nDiagnostics\n.\n12\n(6): 1388.\ndoi\n:\n10.3390\/diagnostics12061388\n.\nPMC\n \n9221910\n.\nPMID\n \n35741198\n.\n^\nPecoraro V, Negro A, Pirotti T, Trenti T (2022).\n\"Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis\"\n.\nEur J Clin Invest\n.\n52\n(2) e13706.\ndoi\n:\n10.1111\/eci.13706\n.\nPMC\n \n8646643\n.\nPMID\n \n34741305\n.\n^\nPu R, Liu S, Ren X, Shi D, Ba Y, Huo Y, et al. 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Retrieved\n8 July\n2022\n.\n^\n\"Council agrees on strengthening the use of rapid antigen tests and on the mutual recognition of COVID-19 test results\"\n. Council of the European Union. 21 January 2021.\nArchived\nfrom the original on 19 May 2021\n. Retrieved\n4 July\n2022\n.\n^\nBiden JR Jr (21 January 2021).\n\"National Strategy for the COVID-19 Response and Pandemic Preparedness\"\n(PDF)\n. White House.\nArchived\n(PDF)\nfrom the original on 9 July 2022\n. Retrieved\n4 July\n2022\n.\n^\n\"Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development\"\n. U.S.\nFood and Drug Administration\n(FDA). 31 March 2021. Archived from\nthe original\non 3 July 2022\n. Retrieved\n4 July\n2022\n.\n^\na\nb\n\"Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication\"\n. U.S.\nFood and Drug Administration\n(FDA). 10 June 2021. Archived from\nthe original\non 25 June 2021\n. 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Retrieved\n4 July\n2022\n.\n^\n\"Counterfeit At-Home OTC COVID-19 Diagnostic Tests\"\n. U.S.\nFood and Drug Administration\n(FDA). 29 April 2022. Archived from\nthe original\non 6 July 2022\n. Retrieved\n4 July\n2022\n.\n^\na\nb\nc\nd\ne\n\"FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities\"\n(Press release). U.S.\nFood and Drug Administration\n(FDA). 1 October 2024. Archived from\nthe original\non 8 October 2024\n. Retrieved\n8 October\n2024\n.\nThis article incorporates text from this source, which is in the\npublic domain\n.\n^\nJakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, et al. (2021).\n\"Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection\"\n.\nDan Med J\n.\n68\n(7): A03210217.\nPMID\n \n34169830\n.\nArchived\nfrom the original on 1 December 2022\n. Retrieved\n10 July\n2022\n.\n^\nDiel R, Hittel N, Nienhaus A (2021).\n\"Point-of-Care COVID-19 Antigen Testing in Exposed German Healthcare Workers-A Cost Model\"\n.\nInt J Environ Res Public Health\n.\n18\n(20) 10767.\ndoi\n:\n10.3390\/ijerph182010767\n.\nPMC\n \n8536062\n.\nPMID\n \n34682514\n.\n^\nDu Z, Pandey A, Bai Y, Fitzpatrick MC, Chinazzi M, Pastore y Piontti A, et al. (2021).\n\"Comparative cost-effectiveness of SARS-CoV-2 testing strategies in the USA: a modelling study\"\n.\nLancet Public Health\n.\n6\n(3):\ne184–\ne191.\ndoi\n:\n10.1016\/S2468-2667(21)00002-5\n.\nPMC\n \n7862022\n.\nPMID\n \n33549196\n.\n^\nPaltiel AD, Zheng A, Sax PE (2021).\n\"Clinical and Economic Effects of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission\"\n.\nAnn Intern Med\n.\n174\n(6):\n803–\n810.\ndoi\n:\n10.7326\/M21-0510\n.\nPMC\n \n9317280\n.\nPMID\n \n33683930\n.\n^\n\"Global COVID-19 Rapid Antigen Test Kits Market Research Report 2022\"\n. Market Reports World. 10 June 2022.\nArchived\nfrom the original on 19 February 2023\n. Retrieved\n10 July\n2022\n.\n^\n\"COVID-19 Rapid Antigen Test Kits Market - Global Outlook & Forecast 2022-2027\"\n. Arizton Advisory & Intelligence. June 2022.\nArchived\nfrom the original on 10 July 2022\n. Retrieved\n10 July\n2022\n.\n^\n\"Global COVID-19 Antigen Test Market Size study, by Product & Service (Platforms, Reagents & Kits and Services), by End-Use (Clinics & Hospitals, Home Care, Diagnostic Labs and Others) and Regional Forecasts 2021–2027\"\n. Market Study Report. 17 July 2021. Archived from\nthe original\non 15 August 2022\n. Retrieved\n10 July\n2022\n.","attrs_markdown":"[Jump to content](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#bodyContent)\n\nMain menu\n\nMain menu\n\nmove to sidebar\n\nhide\n\nNavigation\n\n- [Main page](https:\/\/en.wikipedia.org\/wiki\/Main_Page \"Visit the main page [z]\")\n- [Contents](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Contents \"Guides to browsing Wikipedia\")\n- [Current events](https:\/\/en.wikipedia.org\/wiki\/Portal:Current_events \"Articles related to current events\")\n- [Random article](https:\/\/en.wikipedia.org\/wiki\/Special:Random \"Visit a randomly selected article [x]\")\n- [About Wikipedia](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:About \"Learn about Wikipedia and how it works\")\n- [Contact us](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Contact_us \"How to contact Wikipedia\")\n\nContribute\n\n- [Help](https:\/\/en.wikipedia.org\/wiki\/Help:Contents \"Guidance on how to use and edit Wikipedia\")\n- [Learn to edit](https:\/\/en.wikipedia.org\/wiki\/Help:Introduction \"Learn how to edit Wikipedia\")\n- [Community portal](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Community_portal \"The hub for editors\")\n- [Recent changes](https:\/\/en.wikipedia.org\/wiki\/Special:RecentChanges \"A list of recent changes to Wikipedia [r]\")\n- [Upload file](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:File_upload_wizard \"Add images or other media for use on Wikipedia\")\n- [Special pages](https:\/\/en.wikipedia.org\/wiki\/Special:SpecialPages \"A list of all special pages [q]\")\n\n[![](https:\/\/en.wikipedia.org\/static\/images\/icons\/enwiki-25.svg) ![Wikipedia](https:\/\/en.wikipedia.org\/static\/images\/mobile\/copyright\/wikipedia-wordmark-en-25.svg) ![The Free Encyclopedia](https:\/\/en.wikipedia.org\/static\/images\/mobile\/copyright\/wikipedia-tagline-en-25.svg)](https:\/\/en.wikipedia.org\/wiki\/Main_Page)\n\n[Search](https:\/\/en.wikipedia.org\/wiki\/Special:Search \"Search Wikipedia [f]\")\n\nAppearance\n\n- [Donate](https:\/\/donate.wikimedia.org\/?wmf_source=donate&wmf_medium=sidebar&wmf_campaign=en.wikipedia.org&uselang=en)\n- [Create account](https:\/\/en.wikipedia.org\/w\/index.php?title=Special:CreateAccount&returnto=COVID-19+rapid+antigen+test \"You are encouraged to create an account and log in; however, it is not mandatory\")\n- [Log in](https:\/\/en.wikipedia.org\/w\/index.php?title=Special:UserLogin&returnto=COVID-19+rapid+antigen+test \"You're encouraged to log in; however, it's not mandatory. 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[o]\")\n\n## Contents\nmove to sidebar\n\nhide\n\n- [(Top)](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test)\n- [1 Uses](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Uses)\n  Toggle Uses subsection\n  - [1\\.1 Use in diagnosis](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Use_in_diagnosis)\n  - [1\\.2 Use in screening](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Use_in_screening)\n  - [1\\.3 Humanitarian uses](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Humanitarian_uses)\n  - [1\\.4 Use for \"return to normal\"](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Use_for_\"return_to_normal\")\n- [2 Concerns about use](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Concerns_about_use)\n  Toggle Concerns about use subsection\n  - [2\\.1 False negatives (low sensitivity)](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#False_negatives_\$low_sensitivity\$)\n  - [2\\.2 Potential for false negative results due to new variants](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Potential_for_false_negative_results_due_to_new_variants)\n  - [2\\.3 False positive results when instructions not followed](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#False_positive_results_when_instructions_not_followed)\n  - [2\\.4 Slow deployment and uptake](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Slow_deployment_and_uptake)\n  - [2\\.5 Toxicity of components](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Toxicity_of_components)\n- [3 Methods](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Methods)\n- [4 History of development and deployment](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#History_of_development_and_deployment)\n  Toggle History of development and deployment subsection\n  - [4\\.1 2020](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#2020)\n  - [4\\.2 2021](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#2021)\n  - [4\\.3 2022](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#2022)\n  - [4\\.4 2024](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#2024)\n- [5 Economic aspects](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Economic_aspects)\n  Toggle Economic aspects subsection\n  - [5\\.1 Costs and cost-effectiveness](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Costs_and_cost-effectiveness)\n  - [5\\.2 Global market value](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Global_market_value)\n- [6 Notes](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#Notes)\n- [7 References](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#References)\n\nToggle the table of contents\n\n# COVID-19 rapid antigen test\n27 languages\n\n- [العربية](https:\/\/ar.wikipedia.org\/wiki\/%D8%A7%D9%84%D8%A7%D8%AE%D8%AA%D8%A8%D8%A7%D8%B1_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D8%B6%D8%AF_%D8%A7%D9%84%D8%B3%D8%B1%D9%8A%D8%B9_%D9%84%D9%83%D9%88%D9%81%D9%8A%D8%AF-19 \"الاختبار المستضد السريع لكوفيد-19 – Arabic\")\n- [Български](https:\/\/bg.wikipedia.org\/wiki\/%D0%91%D1%8A%D1%80%D0%B7_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD%D0%B5%D0%BD_%D1%82%D0%B5%D1%81%D1%82_COVID-19 \"Бърз антигенен тест COVID-19 – Bulgarian\")\n- [Čeština](https:\/\/cs.wikipedia.org\/wiki\/Rychl%C3%BD_antigenn%C3%AD_test_na_covid-19 \"Rychlý antigenní test na covid-19 – Czech\")\n- [Ελληνικά](https:\/\/el.wikipedia.org\/wiki\/COVID-19_%CE%B3%CF%81%CE%AE%CE%B3%CE%BF%CF%81%CE%B7_%CE%B4%CE%BF%CE%BA%CE%B9%CE%BC%CE%AE_%CE%B1%CE%BD%CF%84%CE%B9%CE%B3%CF%8C%CE%BD%CE%BF%CF%85 \"COVID-19 γρήγορη δοκιμή αντιγόνου – Greek\")\n- [Español](https:\/\/es.wikipedia.org\/wiki\/Prueba_r%C3%A1pida_de_ant%C3%ADgeno_COVID-19 \"Prueba rápida de antígeno COVID-19 – Spanish\")\n- [Eesti](https:\/\/et.wikipedia.org\/wiki\/COVID-19_antigeeni_kiirtestid \"COVID-19 antigeeni kiirtestid – Estonian\")\n- [فارسی](https:\/\/fa.wikipedia.org\/wiki\/%D8%A2%D8%B2%D9%85%D8%A7%DB%8C%D8%B4_%D8%B3%D8%B1%DB%8C%D8%B9_%D8%A2%D9%86%D8%AA%DB%8C%E2%80%8C%DA%98%D9%86_%DA%A9%D9%88%D9%88%DB%8C%D8%AF_%DB%B1%DB%B9 \"آزمایش سریع آنتی‌ژن کووید ۱۹ – Persian\")\n- [Suomi](https:\/\/fi.wikipedia.org\/wiki\/COVID-19-pikatestit \"COVID-19-pikatestit – Finnish\")\n- [Galego](https:\/\/gl.wikipedia.org\/wiki\/Proba_r%C3%A1pida_de_ant%C3%ADxeno_COVID-19 \"Proba rápida de antíxeno COVID-19 – Galician\")\n- [Hausa](https:\/\/ha.wikipedia.org\/wiki\/Gwajin_COVID-19_Cikin_Saurin_Antigen \"Gwajin COVID-19 Cikin Saurin Antigen – Hausa\")\n- [Hrvatski](https:\/\/hr.wikipedia.org\/wiki\/Brzi_testovi_na_antigen_COVID-19 \"Brzi testovi na antigen COVID-19 – Croatian\")\n- [Magyar](https:\/\/hu.wikipedia.org\/wiki\/Covid19-antig%C3%A9n_gyorsteszt \"Covid19-antigén gyorsteszt – Hungarian\")\n- [Bahasa Indonesia](https:\/\/id.wikipedia.org\/wiki\/Tes_cepat_antigen_Covid-19 \"Tes cepat antigen Covid-19 – Indonesian\")\n- [Italiano](https:\/\/it.wikipedia.org\/wiki\/Test_antigenico_rapido_per_SARS-CoV-2 \"Test antigenico rapido per SARS-CoV-2 – Italian\")\n- [日本語](https:\/\/ja.wikipedia.org\/wiki\/%E6%8A%97%E5%8E%9F%E6%A4%9C%E6%9F%BB%E3%82%AD%E3%83%83%E3%83%88 \"抗原検査キット – Japanese\")\n- [ಕನ್ನಡ](https:\/\/kn.wikipedia.org\/wiki\/%E0%B2%95%E0%B3%8B%E0%B2%B5%E0%B2%BF%E0%B2%A1%E0%B3%8D-%E0%B3%A7%E0%B3%AF\/%E0%B2%95%E0%B3%8D%E0%B2%B7%E0%B2%BF%E0%B2%AA%E0%B3%8D%E0%B2%B0_%E0%B2%AA%E0%B3%8D%E0%B2%B0%E0%B2%A4%E0%B2%BF%E0%B2%9C%E0%B2%A8%E0%B2%95_%E0%B2%AA%E0%B2%B0%E0%B3%80%E0%B2%95%E0%B3%8D%E0%B2%B7%E0%B3%86%E0%B2%97%E0%B2%B3%E0%B3%81 \"ಕೋವಿಡ್-೧೯\/ಕ್ಷಿಪ್ರ ಪ್ರತಿಜನಕ ಪರೀಕ್ಷೆಗಳು – Kannada\")\n- [한국어](https:\/\/ko.wikipedia.org\/wiki\/%EC%BD%94%EB%A1%9C%EB%82%9819_%EC%8B%A0%EC%86%8D%ED%95%AD%EC%9B%90%EA%B2%80%EC%82%AC \"코로나19 신속항원검사 – Korean\")\n- [Latviešu](https:\/\/lv.wikipedia.org\/wiki\/COVID-19_%C4%81trais_antig%C4%93nu_tests \"COVID-19 ātrais antigēnu tests – Latvian\")\n- [Nederlands](https:\/\/nl.wikipedia.org\/wiki\/COVID-19-antigeen-sneltests \"COVID-19-antigeen-sneltests – Dutch\")\n- [Português](https:\/\/pt.wikipedia.org\/wiki\/Teste_r%C3%A1pido_de_antig%C3%A9nios_COVID-19 \"Teste rápido de antigénios COVID-19 – Portuguese\")\n- [Română](https:\/\/ro.wikipedia.org\/wiki\/Teste_rapide_de_antigeni_COVID-19 \"Teste rapide de antigeni COVID-19 – Romanian\")\n- [Русский](https:\/\/ru.wikipedia.org\/wiki\/%D0%91%D1%8B%D1%81%D1%82%D1%80%D1%8B%D0%B9_%D1%82%D0%B5%D1%81%D1%82_%D0%BD%D0%B0_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD_COVID-19 \"Быстрый тест на антиген COVID-19 – Russian\")\n- [Slovenčina](https:\/\/sk.wikipedia.org\/wiki\/R%C3%BDchly_antig%C3%A9nov%C3%BD_test_COVID-19 \"Rýchly antigénový test COVID-19 – Slovak\")\n- [Slovenščina](https:\/\/sl.wikipedia.org\/wiki\/Hitri_antigenski_test_COVID-19 \"Hitri antigenski test COVID-19 – Slovenian\")\n- [Українська](https:\/\/uk.wikipedia.org\/wiki\/%D0%95%D0%BA%D1%81%D0%BF%D1%80%D0%B5%D1%81-%D1%82%D0%B5%D1%81%D1%82%D0%B8_%D0%BD%D0%B0_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD_COVID-19 \"Експрес-тести на антиген COVID-19 – Ukrainian\")\n- [اردو](https:\/\/ur.wikipedia.org\/wiki\/%D8%B1%DB%8C%D8%A7%D9%BE%DA%88_%D8%A7%DB%8C%D9%86%D9%B9%DB%8C%D8%AC%D9%86_%D9%B9%DB%8C%D8%B3%D9%B9_\$%DA%A9%D9%88%D9%88%DA%88_19\$ \"ریاپڈ اینٹیجن ٹیسٹ (کووڈ 19) – Urdu\")\n- [中文](https:\/\/zh.wikipedia.org\/wiki\/2019%E5%86%A0%E7%8B%80%E7%97%85%E6%AF%92%E7%97%85%E5%BF%AB%E9%80%9F%E6%8A%97%E5%8E%9F%E6%AA%A2%E6%B8%AC \"2019冠狀病毒病快速抗原檢測 – Chinese\")\n\n[Edit links](https:\/\/www.wikidata.org\/wiki\/Special:EntityPage\/Q106915773#sitelinks-wikipedia \"Edit interlanguage links\")\n\n- [Article](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test \"View the content page [c]\")\n- [Talk](https:\/\/en.wikipedia.org\/wiki\/Talk:COVID-19_rapid_antigen_test \"Discuss 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PDF](https:\/\/en.wikipedia.org\/w\/index.php?title=Special:DownloadAsPdf&page=COVID-19_rapid_antigen_test&action=show-download-screen \"Download this page as a PDF file\")\n- [Printable version](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&printable=yes \"Printable version of this page [p]\")\n\nIn other projects\n\n- [Wikimedia Commons](https:\/\/commons.wikimedia.org\/wiki\/Category:COVID-19_rapid_antigen_tests)\n- [Wikidata item](https:\/\/www.wikidata.org\/wiki\/Special:EntityPage\/Q106915773 \"Structured data on this page hosted by Wikidata [g]\")\n\nAppearance\n\nmove to sidebar\n\nhide\n\nFrom Wikipedia, the free encyclopedia\n\nDiagnostic test for a SARS-CoV-2 infection\n\nMedical diagnostic method\n\n| COVID-19 rapid antigen test |   |\n|---|---|\n| [![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/6\/6c\/Lateral_flow_covid_19_negative_and_positive_test.jpg\/250px-Lateral_flow_covid_19_negative_and_positive_test.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Lateral_flow_covid_19_negative_and_positive_test.jpg)Negative (left, showing Control line) and positive (right, showing Control and Test lines) results |   |\n| [Synonyms](https:\/\/en.wikipedia.org\/wiki\/Synonym \"Synonym\") | SARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test[\\[a\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-1) |\n| Purpose | To diagnose [SARS-CoV-2](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2 \"SARS-CoV-2\") infections ([COVID-19](https:\/\/en.wikipedia.org\/wiki\/COVID-19 \"COVID-19\")) |\n| [LOINC](https:\/\/en.wikipedia.org\/wiki\/LOINC \"LOINC\") | [94558-4](https:\/\/s.details.loinc.org\/LOINC\/94558-4.html?sections=Comprehensive), [95209-3](https:\/\/s.details.loinc.org\/LOINC\/95209-3.html?sections=Comprehensive), [96119-3](https:\/\/s.details.loinc.org\/LOINC\/96119-3.html?sections=Comprehensive), [97097-0](https:\/\/s.details.loinc.org\/LOINC\/97097-0.html?sections=Comprehensive) |\n\n**COVID-19 rapid antigen tests** or **RAT**s, also frequently called **COVID-19 [lateral flow tests](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_test \"Lateral flow test\")** or **LFT**s, are [rapid antigen tests](https:\/\/en.wikipedia.org\/wiki\/Rapid_antigen_test \"Rapid antigen test\") used to detect [SARS-CoV-2](https:\/\/en.wikipedia.org\/wiki\/Severe_acute_respiratory_syndrome_coronavirus_2 \"Severe acute respiratory syndrome coronavirus 2\") infection ([COVID-19](https:\/\/en.wikipedia.org\/wiki\/COVID-19 \"COVID-19\")). They are quick to implement with minimal training, cost a fraction of other forms of [COVID-19 testing](https:\/\/en.wikipedia.org\/wiki\/COVID-19_testing \"COVID-19 testing\"), and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.[\\[1\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2) Many RATs can be used for self-testing, in which an individual \"collects their own specimen… and interpret\\[s\\] their test result themselves\".[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3)\n\n[False positives](https:\/\/en.wikipedia.org\/wiki\/False_positive \"False positive\") are very rare; the tests' [specificity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") is 98%-99%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) However, the tests have a [sensitivity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") of 70%-72%,[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) which is lower than COVID-19 [polymerase chain reaction](https:\/\/en.wikipedia.org\/wiki\/Polymerase_chain_reaction \"Polymerase chain reaction\") (PCR) tests' sensitivity of 88%-96%.[\\[6\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pecoraro2022-7)[\\[7\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pu2022-8)[\\[b\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-9) Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the [viral load](https:\/\/en.wikipedia.org\/wiki\/Viral_load \"Viral load\") is higher.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)[\\[8\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Oxford2020-10)[\\[9\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Guglielmi2020-11)\n\n## Uses\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=1 \"Edit section: Uses\")\\]\n\n### Use in diagnosis\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=2 \"Edit section: Use in diagnosis\")\\]\n\nCOVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a \"confirmed case of SARS-CoV-2 infection\" in two ways.[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) First, the person with a positive Antigen-RDT could meet a \"probable case definition\" such as having recent loss of smell or taste without any known cause, or could meet certain \"suspect criteria\" such as having a severe acute respiratory illness.[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Second, the person with a positive Antigen-RDT could be asymptomatic but a \"contact of a probable or confirmed case.\"[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a \"confirmed case.\"[\\[11\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NZ2022-13)\n\n### Use in screening\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=3 \"Edit section: Use in screening\")\\]\n\nBetween 2020 and 2021, studies using [mathematical models](https:\/\/en.wikipedia.org\/wiki\/Mathematical_model \"Mathematical model\") estimated the benefit of frequent RATs in [screening](https:\/\/en.wikipedia.org\/wiki\/Screening_\$medicine\$ \"Screening (medicine)\") populations for COVID-19. Paltiel *et al* studied a hypothetical college campus with 5000 students.[\\[12\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) Screening all students every two days with a \"low-sensitivity, high-specificity test\" (such as a RAT) would be able to control an outbreak of COVID-19.[\\[12\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) [Mina](https:\/\/en.wikipedia.org\/wiki\/Michael_Mina_\$epidemiologist\$ \"Michael Mina (epidemiologist)\") *et al* theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would \"capture most infections while they are still infectious.\"[\\[13\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) The quick results of RATs would serve to limit asymptomatic spread.[\\[13\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) Larremore *et al* simulated various COVID-19 population screening strategies.[\\[14\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) The researchers found that \"effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity.\"[\\[14\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16)\n\n### Humanitarian uses\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=4 \"Edit section: Humanitarian uses\")\\]\n\nIn addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.[\\[15\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-17) Furthermore, following the closure of national borders in Europe following the emergence of the [Alpha variant](https:\/\/en.wikipedia.org\/wiki\/Alpha_variant \"Alpha variant\") just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,[\\[16\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-18) effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.[\\[17\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-19)[\\[18\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-20) [Médecins Sans Frontières](https:\/\/en.wikipedia.org\/wiki\/M%C3%A9decins_Sans_Fronti%C3%A8res \"Médecins Sans Frontières\") strongly endorsed the use of rapid tests in lower- and middle-income countries, noting \"COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level\".[\\[19\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-21)\n\n### Use for \"return to normal\"\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=5 \"Edit section: Use for \\\"return to normal\\\"\")\\]\n\nSpain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,[\\[20\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-22) and a free music concert held in [Barcelona](https:\/\/en.wikipedia.org\/wiki\/Barcelona \"Barcelona\") for individuals who took a rapid test.[\\[21\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-23) A similar approach was taken in [Albania](https:\/\/en.wikipedia.org\/wiki\/Albania \"Albania\") to enable music festivals.[\\[22\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-24) However, many experts were unsure of this approach believing that \"rapid tests are not the solution to restart normal life\"[\\[23\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-25) but might be used in conjunction with other infection control techniques.[\\[24\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-26)\n\n## Concerns about use\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=6 \"Edit section: Concerns about use\")\\]\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/90\/COVID-19_rapid_antigen_test_Certification.jpg\/250px-COVID-19_rapid_antigen_test_Certification.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:COVID-19_rapid_antigen_test_Certification.jpg)\n\nA certification of quality for a COVID-19 rapid antigen home test.\n\n### False negatives (low sensitivity)\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=7 \"Edit section: False negatives (low sensitivity)\")\\]\n\nAlthough the [specificity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") of RATs are high (98%-99%),[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) in 2020 RATs were criticized for having a [sensitivity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.[\\[25\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Service2020-27)[\\[26\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Saxena2020-28)[\\[27\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Halliday2020-29) As of 2022, [systematic reviews](https:\/\/en.wikipedia.org\/wiki\/Systematic_review \"Systematic review\") determined that the pooled sensitivities of RATs were 70%-72%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) In one systematic review, the range of sensitivities across studies was 37%-90%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4) As the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) recommends RATs with \"≥ 80% sensitivity\",[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) many RATs do not meet the WHO recommendation.\n\nIn the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) RATs were more sensitive when samples had more viral load, as measured by a low PCR \"cycle threshold,\" and less sensitive when the samples had less viral load.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)\n\nA 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31)\n\n### Potential for false negative results due to new variants\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=8 \"Edit section: Potential for false negative results due to new variants\")\\]\n\nIn November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the [SARS-CoV-2 Alpha variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Alpha_variant \"SARS-CoV-2 Alpha variant\"). The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours [Public Health England](https:\/\/en.wikipedia.org\/wiki\/Public_Health_England \"Public Health England\") laboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the [capsid](https:\/\/en.wikipedia.org\/wiki\/Capsid \"Capsid\") protein and not the [spike protein](https:\/\/en.wikipedia.org\/wiki\/Coronavirus_spike_protein \"Coronavirus spike protein\").[\\[30\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-32) Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.[\\[31\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.[\\[31\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the [Delta variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Delta_variant \"SARS-CoV-2 Delta variant\") and 69.6%-78.3% for the [Omicron variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Omicron_variant \"SARS-CoV-2 Omicron variant\") across a range of [viral loads](https:\/\/en.wikipedia.org\/wiki\/Viral_load \"Viral load\"); however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.[\\[32\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bayart2022-34)\n\n### False positive results when instructions not followed\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=9 \"Edit section: False positive results when instructions not followed\")\\]\n\nIf a COVID-19 RAT is used outside manufacturer recommendations, the result can be [false positive](https:\/\/en.wikipedia.org\/wiki\/False_positives_and_false_negatives#False_positive_error \"False positives and false negatives\"). Beginning in December 2020, [TikTok](https:\/\/en.wikipedia.org\/wiki\/TikTok \"TikTok\") videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.[\\[33\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Lorch2022-35) Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended [buffer solution](https:\/\/en.wikipedia.org\/wiki\/Buffer_solution \"Buffer solution\") produced false positives.[\\[34\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.[\\[34\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36)\n\n### Slow deployment and uptake\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=10 \"Edit section: Slow deployment and uptake\")\\]\n\nSome have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.[\\[35\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Holliday2021-37)\n\n### Toxicity of components\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=11 \"Edit section: Toxicity of components\")\\]\n\nVarious concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.[\\[36\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-38) On 24 February 2022, [Health Canada](https:\/\/en.wikipedia.org\/wiki\/Health_Canada \"Health Canada\") issued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives[\\[37\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-39) [sodium azide](https:\/\/en.wikipedia.org\/wiki\/Sodium_azide \"Sodium azide\") and ProClin.[\\[38\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-40)\n\n## Methods\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=12 \"Edit section: Methods\")\\]\n\nAn [antigen](https:\/\/en.wikipedia.org\/wiki\/Antigen \"Antigen\") is a foreign [molecule](https:\/\/en.wikipedia.org\/wiki\/Molecule \"Molecule\") or molecular [structure](https:\/\/en.wikipedia.org\/wiki\/Structure \"Structure\") that can cause an [immune response](https:\/\/en.wikipedia.org\/wiki\/Immune_response \"Immune response\"). COVID-19 rapid antigen tests (RATs) detect antigenic [proteins](https:\/\/en.wikipedia.org\/wiki\/Protein \"Protein\") on the surface of or in the interior of the SARS-CoV-2 [coronavirus](https:\/\/en.wikipedia.org\/wiki\/Coronavirus \"Coronavirus\"). Of the COVID-19 RATs that had received an [emergency use authorization](https:\/\/en.wikipedia.org\/wiki\/Emergency_use_authorization \"Emergency use authorization\") (EUA) from the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") (FDA) by January 2022, all detected [nucleocapsid](https:\/\/en.wikipedia.org\/wiki\/Nucleocapsid \"Nucleocapsid\") proteins, and one also detected the receptor-binding domain of the [coronavirus spike protein](https:\/\/en.wikipedia.org\/wiki\/Coronavirus_spike_protein \"Coronavirus spike protein\").[\\[39\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1  Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.[\\[40\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EUCommonList2020-42)\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/d\/d3\/Lateral_Flow_Assay.jpg\/330px-Lateral_Flow_Assay.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Lateral_Flow_Assay.jpg)\n\nRapid antigen test functioning by [lateral flow assay](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_assay \"Lateral flow assay\").\n\nA typical COVID-19 RAT is a [lateral flow test](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_test \"Lateral flow test\") (LFT).[\\[39\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 [\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) For an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.[\\[42\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\\[43\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) The liquid is pulled through the strip by wicking ([capillary action](https:\/\/en.wikipedia.org\/wiki\/Capillary_action \"Capillary action\")), encountering different chemically-enhanced regions embedded within the strip.\n\nFirst, at a \"conjugate pad,\" soluble antibodies with gold [nanoparticles](https:\/\/en.wikipedia.org\/wiki\/Nanoparticle \"Nanoparticle\") are picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Then, at the test line (which may be labelled \"T\"), [antibodies](https:\/\/en.wikipedia.org\/wiki\/Antibodies \"Antibodies\") specific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Finally at the control line (which may be labelled \"C\"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)\n\nIf there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)[\\[42\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\\[43\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Frew2021-45)\n\n## History of development and deployment\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=13 \"Edit section: History of development and deployment\")\\]\n\nMain article: [Development of COVID-19 tests](https:\/\/en.wikipedia.org\/wiki\/Development_of_COVID-19_tests \"Development of COVID-19 tests\")\n\n### 2020\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=14 \"Edit section: 2020\")\\]\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/f\/f5\/Covid-19_rapid_test_in_Rwanda.jpg\/330px-Covid-19_rapid_test_in_Rwanda.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Covid-19_rapid_test_in_Rwanda.jpg)\n\nCOVID-19 rapid test being administered in Rwanda\n\nIn May 2020, the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") (FDA) issued the first [emergency use authorization](https:\/\/en.wikipedia.org\/wiki\/Emergency_use_authorization \"Emergency use authorization\") (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by [Quidel](https:\/\/en.wikipedia.org\/wiki\/Quidel \"Quidel\").[\\[44\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAQuidel2020-46)\n\nIn August 2020, the [United States Department of Health and Human Services](https:\/\/en.wikipedia.org\/wiki\/United_States_Department_of_Health_and_Human_Services \"United States Department of Health and Human Services\") announced that the US government would be purchasing 150 million BinaxNOW RATs produced by [Abbott Laboratories](https:\/\/en.wikipedia.org\/wiki\/Abbott_Laboratories \"Abbott Laboratories\") \"to expand strategic, evidence-based testing.\"[\\[45\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-HHS2020-47) Later the agency announced that 100 million of the tests were to be sent to governors to use \"at their discretion,\" for example to reopen schools.[\\[46\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Blad2020-48)\n\nBy September 2020, it was reported that the United Kingdom's [Moonshot program](https:\/\/en.wikipedia.org\/wiki\/Operation_Moonshot \"Operation Moonshot\") would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.[\\[47\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Iacobucci2020-49) In that month, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) released interim guidance on COVID-19 \"antigen-detecting rapid diagnostic tests\" (Ag-RDTs) including recommendations for their use, selection, and implementation.[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The interim guidance noted that Ag-RDTs were easier to implement and less expensive than [nucleic acid](https:\/\/en.wikipedia.org\/wiki\/Nucleic_acid \"Nucleic acid\") amplification tests (NAATs).[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50)\n\n[Health Canada](https:\/\/en.wikipedia.org\/wiki\/Health_Canada \"Health Canada\") approved its first COVID-19 RAT in October 2020, the Abbott Panbio test.[\\[49\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tasker2020-51) As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.[\\[50\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52)[\\[51\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bonislawski2020-53) RATs began to be rolled out across Portuguese schools and care homes.[\\[52\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-54)\n\nOne of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by [Public Health England](https:\/\/en.wikipedia.org\/wiki\/Public_Health_England \"Public Health England\") and [University of Oxford](https:\/\/en.wikipedia.org\/wiki\/University_of_Oxford \"University of Oxford\"), with a preliminary report released in November 2020.[\\[53\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Oxford2020a-55) The researchers undertook an evaluation of 64 LFDs that proceeded in several phases.[\\[54\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) Of the four LFDs with \"desirable performance characteristics,\" one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.[\\[54\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Peto2021-56)\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/e\/e7\/NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg\/250px-NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)\n\nContents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system.\n\nOn 2 November 2020, [Slovakia](https:\/\/en.wikipedia.org\/wiki\/Slovakia \"Slovakia\") became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD [Biosensor](https:\/\/en.wikipedia.org\/wiki\/Biosensor \"Biosensor\") antigen test and performed swabbing on the population.[\\[55\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-57)[\\[56\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-58) Two research studies on the Slovakia experience were published in early 2021, one by professor [Martin Kahanec](https:\/\/en.wikipedia.org\/w\/index.php?title=Martin_Kahanec&action=edit&redlink=1 \"Martin Kahanec (page does not exist)\") from [Central European University](https:\/\/en.wikipedia.org\/wiki\/Central_European_University \"Central European University\") and his coauthors and another one by Martin Pavelka from the [London School of Hygiene & Tropical Medicine](https:\/\/en.wikipedia.org\/wiki\/London_School_of_Hygiene_%26_Tropical_Medicine \"London School of Hygiene & Tropical Medicine\") and his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.[\\[1\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2)[\\[57\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pavelka2021-59)\n\nThe United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the [Prime Minister](https:\/\/en.wikipedia.org\/wiki\/Prime_Minister_of_the_United_Kingdom \"Prime Minister of the United Kingdom\"), [Boris Johnson](https:\/\/en.wikipedia.org\/wiki\/Boris_Johnson \"Boris Johnson\"), started city-wide screening of [Liverpool](https:\/\/en.wikipedia.org\/wiki\/Liverpool \"Liverpool\") as part of the accelerated technology evaluation.[\\[58\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-60)[\\[59\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Littlejohns2020-61) Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at [Durham University](https:\/\/en.wikipedia.org\/wiki\/Durham_University \"Durham University\"), who had the infrastructure and expertise to manage the rapid test programme,[\\[60\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-62) but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[\\[61\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-63) Rapid tests were also implemented within the [National Health Service](https:\/\/en.wikipedia.org\/wiki\/National_Health_Service \"National Health Service\") (NHS) for staff to reduce possible transmission to patients,[\\[62\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-64) local authorities [\\[63\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-65) and care homes to enable visits to visit residents.[\\[64\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-66)[\\[65\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-67) On 18 November 2020, [Wales](https:\/\/en.wikipedia.org\/wiki\/Wales \"Wales\") completed the first whole borough testing at [Merthyr Tydfil](https:\/\/en.wikipedia.org\/wiki\/Merthyr_Tydfil \"Merthyr Tydfil\").[\\[66\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-68)[\\[67\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-69)\n\nGlobal efforts to step up evaluations of rapid tests were initiated by the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the [Bill and Melinda Gates Foundation](https:\/\/en.wikipedia.org\/wiki\/Bill_and_Melinda_Gates_Foundation \"Bill and Melinda Gates Foundation\") that limited costs for low- and middle-income countries.[\\[68\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-70)[\\[69\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-71)\n\nAustria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[\\[70\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-72)[\\[71\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-73)\n\nBy the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[\\[72\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-74) the United Kingdom,[\\[73\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-75) and the US.[\\[74\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-76) These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,[\\[75\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-77) travel hubs in Indonesia,[\\[76\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-78) and across India.[\\[77\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-79)\n\nProfessor [William A. Haseltine](https:\/\/en.wikipedia.org\/wiki\/William_A._Haseltine \"William A. Haseltine\") of Harvard said that \"rapid, self-administered testing could stem the ever-surging tide of disease and death.\"[\\[78\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-80) However, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the \\$900 billion in COVID-19 relief contained within the [Consolidated Appropriations Act, 2021](https:\/\/en.wikipedia.org\/wiki\/Consolidated_Appropriations_Act,_2021 \"Consolidated Appropriations Act, 2021\"). The bill was criticized for not specifically supporting COVID rapid self-tests.[\\[79\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-81) Meanwhile, the FDA authorized the Abbott BinaxNOW RAT \"for prescription use at home.\"[\\[80\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAAbbott2020-82)[\\[81\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Wan2020-83) Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.[\\[82\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-84)\n\nIn the UK in December 2020, the [Medicines and Healthcare products Regulatory Agency](https:\/\/en.wikipedia.org\/wiki\/Medicines_and_Healthcare_products_Regulatory_Agency \"Medicines and Healthcare products Regulatory Agency\") approved the Innova rapid test for self-testing of asymptomatic people.[\\[83\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mahase2020-85) The United Kingdom's chief clinical medic, Dr [Susan Hopkins](https:\/\/en.wikipedia.org\/wiki\/Susan_Hopkins \"Susan Hopkins\"), noted that rapid tests provided a means to find \"people that...we couldn't otherwise find\".[\\[84\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-86)\n\nNoting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the [European Commission](https:\/\/en.wikipedia.org\/wiki\/European_Commission \"European Commission\") (EC) met in December 2020 and developed a common European framework for \"use, validation and mutual recognition of rapid tests\", committing 100 million euros for the purchase of tests from [Roche](https:\/\/en.wikipedia.org\/wiki\/Hoffmann-La_Roche \"Hoffmann-La Roche\") and [Abbott](https:\/\/en.wikipedia.org\/wiki\/Abbott_Laboratories \"Abbott Laboratories\").[\\[85\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EC2020-87) [Stella Kyriakides](https:\/\/en.wikipedia.org\/wiki\/Stella_Kyriakides \"Stella Kyriakides\"), commissioner for Health and Food Safety, said \"Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic.\"[\\[85\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EC2020-87)\n\n### 2021\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=15 \"Edit section: 2021\")\\]\n\nBy January 2021, the [Council of the European Union](https:\/\/en.wikipedia.org\/wiki\/Council_of_the_European_Union \"Council of the European Union\") advocated greater use of rapid tests, noting that \"should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered.\"[\\[86\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EUCouncil2021-88) In the US, newly inaugurated US president [Joe Biden](https:\/\/en.wikipedia.org\/wiki\/Joe_Biden \"Joe Biden\") released a national strategy for COVID-19 that pledged to \"fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available.\"[\\[87\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Biden2021-89) In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.[\\[88\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAOTC2021-90)\n\nInnova voluntarily launched a [Class I recall](https:\/\/en.wikipedia.org\/wiki\/FDA_recall_policies#Class_I \"FDA recall policies\") in the US of more than 77,000 of its RATs in April 2021.[\\[89\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) Two months later, the FDA warned Americans to stop using the test because it had \"significant concerns that the performance of the test has not been adequately established.\"[\\[89\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) A week after the FDA's warning about the Innova test, UK's [Medicines and Healthcare products Regulatory Agency](https:\/\/en.wikipedia.org\/wiki\/Medicines_and_Healthcare_products_Regulatory_Agency \"Medicines and Healthcare products Regulatory Agency\") (MHRA) cleared the rapid diagnostic's use and extended its authorization.[\\[90\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Hale2021-92)\n\nIn October 2021, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) updated its interim guidance on Ag-RDTs.[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of \"higher-than-acceptable false positive test results for SARS-CoV-2\".[\\[91\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAEllume2021-93)\n\nIn December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.[\\[92\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) In response, Dr [Leana Wen](https:\/\/en.wikipedia.org\/wiki\/Leana_Wen \"Leana Wen\") was quoted as saying that the number of tests \"does not come even close to what's needed.\"[\\[92\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2021-94)\n\n### 2022\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=16 \"Edit section: 2022\")\\]\n\nUS president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.[\\[93\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2022-95) In March 2022, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) issued interim guidance on self-testing with Ag-RDTs.[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) The WHO made a strong recommendation that COVID-19 Ag-RDT self-testing \"should be offered in addition to professionally administered testing services.\"[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.[\\[94\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA2022-96)\n\n### 2024\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=17 \"Edit section: 2024\")\\]\n\nIn October 2024, the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") granted marketing authorization for the Healgen Rapid Check COVID-19\/Flu A\\&B Antigen Test.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) Other OTC flu\/COVID tests are available under emergency use authorization.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97)\n\n## Economic aspects\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=18 \"Edit section: Economic aspects\")\\]\n\n### Costs and cost-effectiveness\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=19 \"Edit section: Costs and cost-effectiveness\")\\]\n\nIn late 2020, it was noted that in the US RATs cost [US\\$](https:\/\/en.wikipedia.org\/wiki\/US$ \"US$\")5-\\$23, in contrast with PCR tests which cost at least \\$75.[\\[50\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52) In a Danish study published in 2021, RATs cost about \\$5.70 per test, as opposed to PCRs at \\$10.80 per test.[\\[96\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Jakobsen2021-98) A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.[\\[97\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Diel2021-99) A 2021 study concluded that if the US is willing to pay \\$100,000 per [year of life lost](https:\/\/en.wikipedia.org\/wiki\/Years_of_potential_life_lost \"Years of potential life lost\") averted, then weekly or monthly testing of the population using RATs is likely to be [cost-effective](https:\/\/en.wikipedia.org\/wiki\/Cost-effectiveness_analysis \"Cost-effectiveness analysis\").[\\[98\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-pmid33549196-100) Another 2021 study estimated [incremental cost-effectiveness ratios](https:\/\/en.wikipedia.org\/wiki\/Incremental_cost-effectiveness_ratio \"Incremental cost-effectiveness ratio\") of \"\\$7890 per infection averted and \\$1 430 000 per death averted\" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.[\\[99\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2021-101)\n\n### Global market value\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=20 \"Edit section: Global market value\")\\]\n\nEstimates of value of the worldwide market for RATs vary. One estimate was that the market size was \\$28 billion in 2021 with a [compound annual growth rate](https:\/\/en.wikipedia.org\/wiki\/Compound_annual_growth_rate \"Compound annual growth rate\") (CAGR) of -21.7%, leading to a size of \\$14 billion in 2028.[\\[100\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-MarketReportsWorld2022-102) A second estimate suggested that the market value was \\$4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of \\$743 million in 2027.[\\[101\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Arizton2022-103) A third estimate found a value of \\$5.3 billion in 2020, which was \"anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027.\"[\\[102\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-MarketStudyReport2021-104)\n\n## Notes\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=21 \"Edit section: Notes\")\\]\n\n1. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-1)** \"Point of care test\" and \"rapid test\" could refer to \"rapid antigen test\" but could also refer to tests that use PCR or other technologies.\n2. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-9)** The study by Pecoraro *et al* found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88.\n\n[Portal](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Contents\/Portals \"Wikipedia:Contents\/Portals\"):\n\n- ![icon](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/d\/d6\/WHO_Rod.svg\/20px-WHO_Rod.svg.png) [Medicine](https:\/\/en.wikipedia.org\/wiki\/Portal:Medicine \"Portal:Medicine\")\n\n## References\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=22 \"Edit section: References\")\\]\n\n1. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-1)\n   Kahanec M, Lafférs L, Schmidpeter B (2021). [\"The impact of repeated mass antigen testing for COVID-19 on the prevalence of the disease\"](https:\/\/doi.org\/10.1007%2Fs00148-021-00856-z). *J Popul Econ*. **34** (4): 1105–1140\\. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1007\/s00148-021-00856-z](https:\/\/doi.org\/10.1007%2Fs00148-021-00856-z). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8241209](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8241209). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [34219976](https:\/\/pubmed.ncbi.nlm.nih.gov\/34219976).\n2. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-2)\n   Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report). [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO). 9 March 2022. [hdl](https:\/\/en.wikipedia.org\/wiki\/Hdl_\$identifier\$ \"Hdl (identifier)\"):[10665\/352350](https:\/\/hdl.handle.net\/10665%2F352350). WHO\/2019-nCoV\/Ag-RDTs\/Self\\_testing\/2022.1.\n3. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-6) [***h***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-7)\n   Khalid MF, Selvam K, Jeffry AJ, Salmi MF, Najib MA, Norhayati MN, et al. (4 January 2022). [\"Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis\"](https:\/\/doi.org\/10.3390%2Fdiagnostics12010110). *Diagnostics*. **12** (1): 110. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.3390\/diagnostics12010110](https:\/\/doi.org\/10.3390%2Fdiagnostics12010110). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8774565](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8774565). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35054277](https:\/\/pubmed.ncbi.nlm.nih.gov\/35054277).\n4. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-6)\n   Brümmer LE, Katzenschlager S, McGrath S, Schmitz S, Gaeddert M, Erdmann C, et al. (26 May 2022). [\"Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors\"](https:\/\/doi.org\/10.1371%2Fjournal.pmed.1004011). *PLOS Med*. **19** (5) e1004011. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1371\/journal.pmed.1004011](https:\/\/doi.org\/10.1371%2Fjournal.pmed.1004011). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [9187092](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9187092). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35617375](https:\/\/pubmed.ncbi.nlm.nih.gov\/35617375).\n5. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-6)\n   Tapari A, Braliou GG, Papaefthimiou M, Mavriki H, Kontou PI, Nikolopoulos GK, et al. (4 June 2022). [\"Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis\"](https:\/\/doi.org\/10.3390%2Fdiagnostics12061388). *Diagnostics*. **12** (6): 1388. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.3390\/diagnostics12061388](https:\/\/doi.org\/10.3390%2Fdiagnostics12061388). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [9221910](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9221910). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35741198](https:\/\/pubmed.ncbi.nlm.nih.gov\/35741198).\n6. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Pecoraro2022_7-0)**\n   Pecoraro V, Negro A, Pirotti T, Trenti T (2022). [\"Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis\"](https:\/\/doi.org\/10.1111%2Feci.13706). *Eur J Clin Invest*. **52** (2) e13706. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1111\/eci.13706](https:\/\/doi.org\/10.1111%2Feci.13706). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8646643](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8646643). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [34741305](https:\/\/pubmed.ncbi.nlm.nih.gov\/34741305).\n7. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Pu2022_8-0)**\n   Pu R, Liu S, Ren X, Shi D, Ba Y, Huo Y, et al. (2022). [\"The screening value of RT-LAMP and RT-PCR in the diagnosis of COVID-19: systematic review and meta-analysis\"](https:\/\/doi.org\/10.1016%2Fj.jviromet.2021.114392). *J Virol Methods*. **300** 114392. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1016\/j.jviromet.2021.114392](https:\/\/doi.org\/10.1016%2Fj.jviromet.2021.114392). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8629515](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8629515). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [34856308](https:\/\/pubmed.ncbi.nlm.nih.gov\/34856308).\n8. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Oxford2020_10-0)**\n   [\"Oxford University and PHE confirm lateral flow tests show high specificity and are effective at identifying most individuals who are infectious\"](https:\/\/www.ox.ac.uk\/news\/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are). *Oxford University*. 11 November 2020. [Archived](https:\/\/web.archive.org\/web\/20210717053744\/https:\/\/www.ox.ac.uk\/news\/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are) from the original on 17 July 2021. Retrieved 19 May 2021.\n9. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Guglielmi2020_11-0)**\n   Guglielmi G (2020). [\"Fast coronavirus tests: what they can and can't do\"](https:\/\/doi.org\/10.1038%2Fd41586-020-02661-2). *Nature*. **585** (7826): 496–498\\. [Bibcode](https:\/\/en.wikipedia.org\/wiki\/Bibcode_\$identifier\$ \"Bibcode (identifier)\"):[2020Natur.585..496G](https:\/\/ui.adsabs.harvard.edu\/abs\/2020Natur.585..496G). [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1038\/d41586-020-02661-2](https:\/\/doi.org\/10.1038%2Fd41586-020-02661-2). 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Retrieved 8 July 2022.\n11. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-NZ2022_13-0)**\n    [\"Case definition and clinical testing guidelines for COVID-19\"](https:\/\/web.archive.org\/web\/20220709053911\/https:\/\/www.health.govt.nz\/covid-19-novel-coronavirus\/covid-19-information-health-professionals\/case-definition-and-clinical-testing-guidelines-covid-19). *Ministry of Health NZ*. [New Zealand Ministry of Health – Manatū Hauora](https:\/\/en.wikipedia.org\/wiki\/Ministry_of_Health_\$New_Zealand\$ \"Ministry of Health (New Zealand)\"). 30 June 2022. Archived from [the original](https:\/\/www.health.govt.nz\/covid-19-novel-coronavirus\/covid-19-information-health-professionals\/case-definition-and-clinical-testing-guidelines-covid-19) on 9 July 2022. Retrieved 8 July 2022.\n12. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Paltiel2020_14-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Paltiel2020_14-1)\n    Paltiel AD, Zheng A, Walensky RP (2020). [\"Assessment of SARS-CoV-2 Screening Strategies to Permit the Safe Reopening of College Campuses in the United States\"](https:\/\/doi.org\/10.1001%2Fjamanetworkopen.2020.16818). *JAMA Netw Open*. **3** (7): e2016818. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1001\/jamanetworkopen.2020.16818](https:\/\/doi.org\/10.1001%2Fjamanetworkopen.2020.16818). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [7395236](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7395236). 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[PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [32997903](https:\/\/pubmed.ncbi.nlm.nih.gov\/32997903).\n14. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Larremore2021_16-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Larremore2021_16-1)\n    Larremore DB, Wilder B, Lester E, Shehata S, Burke JM, Hay JA, et al. (2021). [\"Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening\"](https:\/\/doi.org\/10.1126%2Fsciadv.abd5393). *Science Advances*. **7** (1) eabd5393. [Bibcode](https:\/\/en.wikipedia.org\/wiki\/Bibcode_\$identifier\$ \"Bibcode (identifier)\"):[2021SciA....7.5393L](https:\/\/ui.adsabs.harvard.edu\/abs\/2021SciA....7.5393L). [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1126\/sciadv.abd5393](https:\/\/doi.org\/10.1126%2Fsciadv.abd5393). 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Wikipedia® is a registered trademark of the [Wikimedia Foundation, Inc.](https:\/\/wikimediafoundation.org\/), a non-profit organization.\n\n- [Privacy policy](https:\/\/foundation.wikimedia.org\/wiki\/Special:MyLanguage\/Policy:Privacy_policy)\n- [About Wikipedia](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:About)\n- [Disclaimers](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:General_disclaimer)\n- [Contact Wikipedia](https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Contact_us)\n- [Legal & safety contacts](https:\/\/foundation.wikimedia.org\/wiki\/Special:MyLanguage\/Legal:Wikimedia_Foundation_Legal_and_Safety_Contact_Information)\n- [Code of Conduct](https:\/\/foundation.wikimedia.org\/wiki\/Special:MyLanguage\/Policy:Universal_Code_of_Conduct)\n- [Developers](https:\/\/developer.wikimedia.org\/)\n- [Statistics](https:\/\/stats.wikimedia.org\/#\/en.wikipedia.org)\n- [Cookie statement](https:\/\/foundation.wikimedia.org\/wiki\/Special:MyLanguage\/Policy:Cookie_statement)\n- [Mobile view](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&mobileaction=toggle_view_mobile)\n\n- [![Wikimedia Foundation](https:\/\/en.wikipedia.org\/static\/images\/footer\/wikimedia.svg)](https:\/\/www.wikimedia.org\/)\n- [![Powered by MediaWiki](https:\/\/en.wikipedia.org\/w\/resources\/assets\/mediawiki_compact.svg)](https:\/\/www.mediawiki.org\/)\n\nSearch\n\nToggle the table of contents\n\nCOVID-19 rapid antigen test\n\n27 languages\n\n[Add topic](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test)","attrs_readable_markdown":"From Wikipedia, the free encyclopedia\n\n| COVID-19 rapid antigen test |   |\n|---|---|\n| [![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/6\/6c\/Lateral_flow_covid_19_negative_and_positive_test.jpg\/250px-Lateral_flow_covid_19_negative_and_positive_test.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Lateral_flow_covid_19_negative_and_positive_test.jpg)Negative (left, showing Control line) and positive (right, showing Control and Test lines) results |   |\n| [Synonyms](https:\/\/en.wikipedia.org\/wiki\/Synonym \"Synonym\") | SARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test[\\[a\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-1) |\n| Purpose | To diagnose [SARS-CoV-2](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2 \"SARS-CoV-2\") infections ([COVID-19](https:\/\/en.wikipedia.org\/wiki\/COVID-19 \"COVID-19\")) |\n| [LOINC](https:\/\/en.wikipedia.org\/wiki\/LOINC \"LOINC\") | [94558-4](https:\/\/s.details.loinc.org\/LOINC\/94558-4.html?sections=Comprehensive), [95209-3](https:\/\/s.details.loinc.org\/LOINC\/95209-3.html?sections=Comprehensive), [96119-3](https:\/\/s.details.loinc.org\/LOINC\/96119-3.html?sections=Comprehensive), [97097-0](https:\/\/s.details.loinc.org\/LOINC\/97097-0.html?sections=Comprehensive) |\n\n**COVID-19 rapid antigen tests** or **RAT**s, also frequently called **COVID-19 [lateral flow tests](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_test \"Lateral flow test\")** or **LFT**s, are [rapid antigen tests](https:\/\/en.wikipedia.org\/wiki\/Rapid_antigen_test \"Rapid antigen test\") used to detect [SARS-CoV-2](https:\/\/en.wikipedia.org\/wiki\/Severe_acute_respiratory_syndrome_coronavirus_2 \"Severe acute respiratory syndrome coronavirus 2\") infection ([COVID-19](https:\/\/en.wikipedia.org\/wiki\/COVID-19 \"COVID-19\")). They are quick to implement with minimal training, cost a fraction of other forms of [COVID-19 testing](https:\/\/en.wikipedia.org\/wiki\/COVID-19_testing \"COVID-19 testing\"), and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.[\\[1\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2) Many RATs can be used for self-testing, in which an individual \"collects their own specimen… and interpret\\[s\\] their test result themselves\".[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3)\n\n[False positives](https:\/\/en.wikipedia.org\/wiki\/False_positive \"False positive\") are very rare; the tests' [specificity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") is 98%-99%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) However, the tests have a [sensitivity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") of 70%-72%,[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) which is lower than COVID-19 [polymerase chain reaction](https:\/\/en.wikipedia.org\/wiki\/Polymerase_chain_reaction \"Polymerase chain reaction\") (PCR) tests' sensitivity of 88%-96%.[\\[6\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pecoraro2022-7)[\\[7\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pu2022-8)[\\[b\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-9) Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the [viral load](https:\/\/en.wikipedia.org\/wiki\/Viral_load \"Viral load\") is higher.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)[\\[8\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Oxford2020-10)[\\[9\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Guglielmi2020-11)\n\nCOVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a \"confirmed case of SARS-CoV-2 infection\" in two ways.[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) First, the person with a positive Antigen-RDT could meet a \"probable case definition\" such as having recent loss of smell or taste without any known cause, or could meet certain \"suspect criteria\" such as having a severe acute respiratory illness.[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Second, the person with a positive Antigen-RDT could be asymptomatic but a \"contact of a probable or confirmed case.\"[\\[10\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a \"confirmed case.\"[\\[11\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NZ2022-13)\n\nBetween 2020 and 2021, studies using [mathematical models](https:\/\/en.wikipedia.org\/wiki\/Mathematical_model \"Mathematical model\") estimated the benefit of frequent RATs in [screening](https:\/\/en.wikipedia.org\/wiki\/Screening_\$medicine\$ \"Screening (medicine)\") populations for COVID-19. Paltiel *et al* studied a hypothetical college campus with 5000 students.[\\[12\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) Screening all students every two days with a \"low-sensitivity, high-specificity test\" (such as a RAT) would be able to control an outbreak of COVID-19.[\\[12\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) [Mina](https:\/\/en.wikipedia.org\/wiki\/Michael_Mina_\$epidemiologist\$ \"Michael Mina (epidemiologist)\") *et al* theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would \"capture most infections while they are still infectious.\"[\\[13\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) The quick results of RATs would serve to limit asymptomatic spread.[\\[13\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) Larremore *et al* simulated various COVID-19 population screening strategies.[\\[14\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) The researchers found that \"effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity.\"[\\[14\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16)\n\nIn addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.[\\[15\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-17) Furthermore, following the closure of national borders in Europe following the emergence of the [Alpha variant](https:\/\/en.wikipedia.org\/wiki\/Alpha_variant \"Alpha variant\") just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,[\\[16\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-18) effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.[\\[17\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-19)[\\[18\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-20) [Médecins Sans Frontières](https:\/\/en.wikipedia.org\/wiki\/M%C3%A9decins_Sans_Fronti%C3%A8res \"Médecins Sans Frontières\") strongly endorsed the use of rapid tests in lower- and middle-income countries, noting \"COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level\".[\\[19\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-21)\n\n### Use for \"return to normal\"\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=5 \"Edit section: Use for \\\"return to normal\\\"\")\\]\n\nSpain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,[\\[20\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-22) and a free music concert held in [Barcelona](https:\/\/en.wikipedia.org\/wiki\/Barcelona \"Barcelona\") for individuals who took a rapid test.[\\[21\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-23) A similar approach was taken in [Albania](https:\/\/en.wikipedia.org\/wiki\/Albania \"Albania\") to enable music festivals.[\\[22\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-24) However, many experts were unsure of this approach believing that \"rapid tests are not the solution to restart normal life\"[\\[23\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-25) but might be used in conjunction with other infection control techniques.[\\[24\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-26)\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/90\/COVID-19_rapid_antigen_test_Certification.jpg\/250px-COVID-19_rapid_antigen_test_Certification.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:COVID-19_rapid_antigen_test_Certification.jpg)\n\nA certification of quality for a COVID-19 rapid antigen home test.\n\n### False negatives (low sensitivity)\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=7 \"Edit section: False negatives (low sensitivity)\")\\]\n\nAlthough the [specificity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") of RATs are high (98%-99%),[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) in 2020 RATs were criticized for having a [sensitivity](https:\/\/en.wikipedia.org\/wiki\/Sensitivity_and_specificity \"Sensitivity and specificity\") as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.[\\[25\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Service2020-27)[\\[26\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Saxena2020-28)[\\[27\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Halliday2020-29) As of 2022, [systematic reviews](https:\/\/en.wikipedia.org\/wiki\/Systematic_review \"Systematic review\") determined that the pooled sensitivities of RATs were 70%-72%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) In one systematic review, the range of sensitivities across studies was 37%-90%.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4) As the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) recommends RATs with \"≥ 80% sensitivity\",[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) many RATs do not meet the WHO recommendation.\n\nIn the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) RATs were more sensitive when samples had more viral load, as measured by a low PCR \"cycle threshold,\" and less sensitive when the samples had less viral load.[\\[3\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\\[4\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\\[5\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)\n\nA 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.[\\[29\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Chu2022-31)\n\n### Potential for false negative results due to new variants\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=8 \"Edit section: Potential for false negative results due to new variants\")\\]\n\nIn November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the [SARS-CoV-2 Alpha variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Alpha_variant \"SARS-CoV-2 Alpha variant\"). The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours [Public Health England](https:\/\/en.wikipedia.org\/wiki\/Public_Health_England \"Public Health England\") laboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the [capsid](https:\/\/en.wikipedia.org\/wiki\/Capsid \"Capsid\") protein and not the [spike protein](https:\/\/en.wikipedia.org\/wiki\/Coronavirus_spike_protein \"Coronavirus spike protein\").[\\[30\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-32) Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.[\\[31\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.[\\[31\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the [Delta variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Delta_variant \"SARS-CoV-2 Delta variant\") and 69.6%-78.3% for the [Omicron variant](https:\/\/en.wikipedia.org\/wiki\/SARS-CoV-2_Omicron_variant \"SARS-CoV-2 Omicron variant\") across a range of [viral loads](https:\/\/en.wikipedia.org\/wiki\/Viral_load \"Viral load\"); however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.[\\[32\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bayart2022-34)\n\n### False positive results when instructions not followed\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=9 \"Edit section: False positive results when instructions not followed\")\\]\n\nIf a COVID-19 RAT is used outside manufacturer recommendations, the result can be [false positive](https:\/\/en.wikipedia.org\/wiki\/False_positives_and_false_negatives#False_positive_error \"False positives and false negatives\"). Beginning in December 2020, [TikTok](https:\/\/en.wikipedia.org\/wiki\/TikTok \"TikTok\") videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.[\\[33\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Lorch2022-35) Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended [buffer solution](https:\/\/en.wikipedia.org\/wiki\/Buffer_solution \"Buffer solution\") produced false positives.[\\[34\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.[\\[34\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36)\n\n### Slow deployment and uptake\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=10 \"Edit section: Slow deployment and uptake\")\\]\n\nSome have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.[\\[35\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Holliday2021-37)\n\n### Toxicity of components\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=11 \"Edit section: Toxicity of components\")\\]\n\nVarious concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.[\\[36\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-38) On 24 February 2022, [Health Canada](https:\/\/en.wikipedia.org\/wiki\/Health_Canada \"Health Canada\") issued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives[\\[37\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-39) [sodium azide](https:\/\/en.wikipedia.org\/wiki\/Sodium_azide \"Sodium azide\") and ProClin.[\\[38\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-40)\n\nAn [antigen](https:\/\/en.wikipedia.org\/wiki\/Antigen \"Antigen\") is a foreign [molecule](https:\/\/en.wikipedia.org\/wiki\/Molecule \"Molecule\") or molecular [structure](https:\/\/en.wikipedia.org\/wiki\/Structure \"Structure\") that can cause an [immune response](https:\/\/en.wikipedia.org\/wiki\/Immune_response \"Immune response\"). COVID-19 rapid antigen tests (RATs) detect antigenic [proteins](https:\/\/en.wikipedia.org\/wiki\/Protein \"Protein\") on the surface of or in the interior of the SARS-CoV-2 [coronavirus](https:\/\/en.wikipedia.org\/wiki\/Coronavirus \"Coronavirus\"). Of the COVID-19 RATs that had received an [emergency use authorization](https:\/\/en.wikipedia.org\/wiki\/Emergency_use_authorization \"Emergency use authorization\") (EUA) from the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") (FDA) by January 2022, all detected [nucleocapsid](https:\/\/en.wikipedia.org\/wiki\/Nucleocapsid \"Nucleocapsid\") proteins, and one also detected the receptor-binding domain of the [coronavirus spike protein](https:\/\/en.wikipedia.org\/wiki\/Coronavirus_spike_protein \"Coronavirus spike protein\").[\\[39\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1  Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.[\\[40\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EUCommonList2020-42)\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/d\/d3\/Lateral_Flow_Assay.jpg\/330px-Lateral_Flow_Assay.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Lateral_Flow_Assay.jpg)\n\nRapid antigen test functioning by [lateral flow assay](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_assay \"Lateral flow assay\").\n\nA typical COVID-19 RAT is a [lateral flow test](https:\/\/en.wikipedia.org\/wiki\/Lateral_flow_test \"Lateral flow test\") (LFT).[\\[39\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 [\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) For an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.[\\[42\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\\[43\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) The liquid is pulled through the strip by wicking ([capillary action](https:\/\/en.wikipedia.org\/wiki\/Capillary_action \"Capillary action\")), encountering different chemically-enhanced regions embedded within the strip.\n\nFirst, at a \"conjugate pad,\" soluble antibodies with gold [nanoparticles](https:\/\/en.wikipedia.org\/wiki\/Nanoparticle \"Nanoparticle\") are picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Then, at the test line (which may be labelled \"T\"), [antibodies](https:\/\/en.wikipedia.org\/wiki\/Antibodies \"Antibodies\") specific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Finally at the control line (which may be labelled \"C\"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)\n\nIf there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test.[\\[41\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)[\\[42\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\\[43\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Frew2021-45)\n\n## History of development and deployment\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=13 \"Edit section: History of development and deployment\")\\]\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/f\/f5\/Covid-19_rapid_test_in_Rwanda.jpg\/330px-Covid-19_rapid_test_in_Rwanda.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:Covid-19_rapid_test_in_Rwanda.jpg)\n\nCOVID-19 rapid test being administered in Rwanda\n\nIn May 2020, the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") (FDA) issued the first [emergency use authorization](https:\/\/en.wikipedia.org\/wiki\/Emergency_use_authorization \"Emergency use authorization\") (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by [Quidel](https:\/\/en.wikipedia.org\/wiki\/Quidel \"Quidel\").[\\[44\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAQuidel2020-46)\n\nIn August 2020, the [United States Department of Health and Human Services](https:\/\/en.wikipedia.org\/wiki\/United_States_Department_of_Health_and_Human_Services \"United States Department of Health and Human Services\") announced that the US government would be purchasing 150 million BinaxNOW RATs produced by [Abbott Laboratories](https:\/\/en.wikipedia.org\/wiki\/Abbott_Laboratories \"Abbott Laboratories\") \"to expand strategic, evidence-based testing.\"[\\[45\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-HHS2020-47) Later the agency announced that 100 million of the tests were to be sent to governors to use \"at their discretion,\" for example to reopen schools.[\\[46\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Blad2020-48)\n\nBy September 2020, it was reported that the United Kingdom's [Moonshot program](https:\/\/en.wikipedia.org\/wiki\/Operation_Moonshot \"Operation Moonshot\") would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.[\\[47\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Iacobucci2020-49) In that month, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) released interim guidance on COVID-19 \"antigen-detecting rapid diagnostic tests\" (Ag-RDTs) including recommendations for their use, selection, and implementation.[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The interim guidance noted that Ag-RDTs were easier to implement and less expensive than [nucleic acid](https:\/\/en.wikipedia.org\/wiki\/Nucleic_acid \"Nucleic acid\") amplification tests (NAATs).[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.[\\[48\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2020-50)\n\n[Health Canada](https:\/\/en.wikipedia.org\/wiki\/Health_Canada \"Health Canada\") approved its first COVID-19 RAT in October 2020, the Abbott Panbio test.[\\[49\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Tasker2020-51) As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.[\\[50\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52)[\\[51\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Bonislawski2020-53) RATs began to be rolled out across Portuguese schools and care homes.[\\[52\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-54)\n\nOne of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by [Public Health England](https:\/\/en.wikipedia.org\/wiki\/Public_Health_England \"Public Health England\") and [University of Oxford](https:\/\/en.wikipedia.org\/wiki\/University_of_Oxford \"University of Oxford\"), with a preliminary report released in November 2020.[\\[53\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Oxford2020a-55) The researchers undertook an evaluation of 64 LFDs that proceeded in several phases.[\\[54\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) Of the four LFDs with \"desirable performance characteristics,\" one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.[\\[54\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Peto2021-56)\n\n[![](https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/e\/e7\/NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg\/250px-NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)](https:\/\/en.wikipedia.org\/wiki\/File:NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)\n\nContents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system.\n\nOn 2 November 2020, [Slovakia](https:\/\/en.wikipedia.org\/wiki\/Slovakia \"Slovakia\") became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD [Biosensor](https:\/\/en.wikipedia.org\/wiki\/Biosensor \"Biosensor\") antigen test and performed swabbing on the population.[\\[55\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-57)[\\[56\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-58) Two research studies on the Slovakia experience were published in early 2021, one by professor [Martin Kahanec](https:\/\/en.wikipedia.org\/w\/index.php?title=Martin_Kahanec&action=edit&redlink=1 \"Martin Kahanec (page does not exist)\") from [Central European University](https:\/\/en.wikipedia.org\/wiki\/Central_European_University \"Central European University\") and his coauthors and another one by Martin Pavelka from the [London School of Hygiene & Tropical Medicine](https:\/\/en.wikipedia.org\/wiki\/London_School_of_Hygiene_%26_Tropical_Medicine \"London School of Hygiene & Tropical Medicine\") and his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.[\\[1\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2)[\\[57\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Pavelka2021-59)\n\nThe United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the [Prime Minister](https:\/\/en.wikipedia.org\/wiki\/Prime_Minister_of_the_United_Kingdom \"Prime Minister of the United Kingdom\"), [Boris Johnson](https:\/\/en.wikipedia.org\/wiki\/Boris_Johnson \"Boris Johnson\"), started city-wide screening of [Liverpool](https:\/\/en.wikipedia.org\/wiki\/Liverpool \"Liverpool\") as part of the accelerated technology evaluation.[\\[58\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-60)[\\[59\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Littlejohns2020-61) Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at [Durham University](https:\/\/en.wikipedia.org\/wiki\/Durham_University \"Durham University\"), who had the infrastructure and expertise to manage the rapid test programme,[\\[60\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-62) but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[\\[61\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-63) Rapid tests were also implemented within the [National Health Service](https:\/\/en.wikipedia.org\/wiki\/National_Health_Service \"National Health Service\") (NHS) for staff to reduce possible transmission to patients,[\\[62\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-64) local authorities [\\[63\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-65) and care homes to enable visits to visit residents.[\\[64\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-66)[\\[65\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-67) On 18 November 2020, [Wales](https:\/\/en.wikipedia.org\/wiki\/Wales \"Wales\") completed the first whole borough testing at [Merthyr Tydfil](https:\/\/en.wikipedia.org\/wiki\/Merthyr_Tydfil \"Merthyr Tydfil\").[\\[66\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-68)[\\[67\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-69)\n\nGlobal efforts to step up evaluations of rapid tests were initiated by the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the [Bill and Melinda Gates Foundation](https:\/\/en.wikipedia.org\/wiki\/Bill_and_Melinda_Gates_Foundation \"Bill and Melinda Gates Foundation\") that limited costs for low- and middle-income countries.[\\[68\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-70)[\\[69\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-71)\n\nAustria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[\\[70\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-72)[\\[71\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-73)\n\nBy the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[\\[72\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-74) the United Kingdom,[\\[73\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-75) and the US.[\\[74\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-76) These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,[\\[75\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-77) travel hubs in Indonesia,[\\[76\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-78) and across India.[\\[77\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-79)\n\nProfessor [William A. Haseltine](https:\/\/en.wikipedia.org\/wiki\/William_A._Haseltine \"William A. Haseltine\") of Harvard said that \"rapid, self-administered testing could stem the ever-surging tide of disease and death.\"[\\[78\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-80) However, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the \\$900 billion in COVID-19 relief contained within the [Consolidated Appropriations Act, 2021](https:\/\/en.wikipedia.org\/wiki\/Consolidated_Appropriations_Act,_2021 \"Consolidated Appropriations Act, 2021\"). The bill was criticized for not specifically supporting COVID rapid self-tests.[\\[79\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-81) Meanwhile, the FDA authorized the Abbott BinaxNOW RAT \"for prescription use at home.\"[\\[80\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAAbbott2020-82)[\\[81\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Wan2020-83) Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.[\\[82\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-84)\n\nIn the UK in December 2020, the [Medicines and Healthcare products Regulatory Agency](https:\/\/en.wikipedia.org\/wiki\/Medicines_and_Healthcare_products_Regulatory_Agency \"Medicines and Healthcare products Regulatory Agency\") approved the Innova rapid test for self-testing of asymptomatic people.[\\[83\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Mahase2020-85) The United Kingdom's chief clinical medic, Dr [Susan Hopkins](https:\/\/en.wikipedia.org\/wiki\/Susan_Hopkins \"Susan Hopkins\"), noted that rapid tests provided a means to find \"people that...we couldn't otherwise find\".[\\[84\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-86)\n\nNoting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the [European Commission](https:\/\/en.wikipedia.org\/wiki\/European_Commission \"European Commission\") (EC) met in December 2020 and developed a common European framework for \"use, validation and mutual recognition of rapid tests\", committing 100 million euros for the purchase of tests from [Roche](https:\/\/en.wikipedia.org\/wiki\/Hoffmann-La_Roche \"Hoffmann-La Roche\") and [Abbott](https:\/\/en.wikipedia.org\/wiki\/Abbott_Laboratories \"Abbott Laboratories\").[\\[85\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EC2020-87) [Stella Kyriakides](https:\/\/en.wikipedia.org\/wiki\/Stella_Kyriakides \"Stella Kyriakides\"), commissioner for Health and Food Safety, said \"Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic.\"[\\[85\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EC2020-87)\n\nBy January 2021, the [Council of the European Union](https:\/\/en.wikipedia.org\/wiki\/Council_of_the_European_Union \"Council of the European Union\") advocated greater use of rapid tests, noting that \"should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered.\"[\\[86\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-EUCouncil2021-88) In the US, newly inaugurated US president [Joe Biden](https:\/\/en.wikipedia.org\/wiki\/Joe_Biden \"Joe Biden\") released a national strategy for COVID-19 that pledged to \"fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available.\"[\\[87\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Biden2021-89) In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.[\\[88\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAOTC2021-90)\n\nInnova voluntarily launched a [Class I recall](https:\/\/en.wikipedia.org\/wiki\/FDA_recall_policies#Class_I \"FDA recall policies\") in the US of more than 77,000 of its RATs in April 2021.[\\[89\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) Two months later, the FDA warned Americans to stop using the test because it had \"significant concerns that the performance of the test has not been adequately established.\"[\\[89\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) A week after the FDA's warning about the Innova test, UK's [Medicines and Healthcare products Regulatory Agency](https:\/\/en.wikipedia.org\/wiki\/Medicines_and_Healthcare_products_Regulatory_Agency \"Medicines and Healthcare products Regulatory Agency\") (MHRA) cleared the rapid diagnostic's use and extended its authorization.[\\[90\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Hale2021-92)\n\nIn October 2021, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) updated its interim guidance on Ag-RDTs.[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.[\\[28\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of \"higher-than-acceptable false positive test results for SARS-CoV-2\".[\\[91\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDAEllume2021-93)\n\nIn December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.[\\[92\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) In response, Dr [Leana Wen](https:\/\/en.wikipedia.org\/wiki\/Leana_Wen \"Leana Wen\") was quoted as saying that the number of tests \"does not come even close to what's needed.\"[\\[92\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2021-94)\n\nUS president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.[\\[93\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-NPR2022-95) In March 2022, the [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO) issued interim guidance on self-testing with Ag-RDTs.[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) The WHO made a strong recommendation that COVID-19 Ag-RDT self-testing \"should be offered in addition to professionally administered testing services.\"[\\[2\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.[\\[94\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA2022-96)\n\nIn October 2024, the US [Food and Drug Administration](https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration \"Food and Drug Administration\") granted marketing authorization for the Healgen Rapid Check COVID-19\/Flu A\\&B Antigen Test.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) Other OTC flu\/COVID tests are available under emergency use authorization.[\\[95\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97)\n\n### Costs and cost-effectiveness\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=19 \"Edit section: Costs and cost-effectiveness\")\\]\n\nIn late 2020, it was noted that in the US RATs cost [US\\$](https:\/\/en.wikipedia.org\/wiki\/US$ \"US$\")5-\\$23, in contrast with PCR tests which cost at least \\$75.[\\[50\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52) In a Danish study published in 2021, RATs cost about \\$5.70 per test, as opposed to PCRs at \\$10.80 per test.[\\[96\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Jakobsen2021-98) A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.[\\[97\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Diel2021-99) A 2021 study concluded that if the US is willing to pay \\$100,000 per [year of life lost](https:\/\/en.wikipedia.org\/wiki\/Years_of_potential_life_lost \"Years of potential life lost\") averted, then weekly or monthly testing of the population using RATs is likely to be [cost-effective](https:\/\/en.wikipedia.org\/wiki\/Cost-effectiveness_analysis \"Cost-effectiveness analysis\").[\\[98\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-pmid33549196-100) Another 2021 study estimated [incremental cost-effectiveness ratios](https:\/\/en.wikipedia.org\/wiki\/Incremental_cost-effectiveness_ratio \"Incremental cost-effectiveness ratio\") of \"\\$7890 per infection averted and \\$1 430 000 per death averted\" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.[\\[99\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Paltiel2021-101)\n\n### Global market value\n\\[[edit](https:\/\/en.wikipedia.org\/w\/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=20 \"Edit section: Global market value\")\\]\n\nEstimates of value of the worldwide market for RATs vary. One estimate was that the market size was \\$28 billion in 2021 with a [compound annual growth rate](https:\/\/en.wikipedia.org\/wiki\/Compound_annual_growth_rate \"Compound annual growth rate\") (CAGR) of -21.7%, leading to a size of \\$14 billion in 2028.[\\[100\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-MarketReportsWorld2022-102) A second estimate suggested that the market value was \\$4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of \\$743 million in 2027.[\\[101\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-Arizton2022-103) A third estimate found a value of \\$5.3 billion in 2020, which was \"anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027.\"[\\[102\\]](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_note-MarketStudyReport2021-104)\n\n1. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-1)** \"Point of care test\" and \"rapid test\" could refer to \"rapid antigen test\" but could also refer to tests that use PCR or other technologies.\n2. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-9)** The study by Pecoraro *et al* found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88.\n\n1. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-1)\n2. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-2)\n   Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report). [World Health Organization](https:\/\/en.wikipedia.org\/wiki\/World_Health_Organization \"World Health Organization\") (WHO). 9 March 2022. [hdl](https:\/\/en.wikipedia.org\/wiki\/Hdl_\$identifier\$ \"Hdl (identifier)\"):[10665\/352350](https:\/\/hdl.handle.net\/10665%2F352350). WHO\/2019-nCoV\/Ag-RDTs\/Self\\_testing\/2022.1.\n3. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-6) [***h***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-7)\n   Khalid MF, Selvam K, Jeffry AJ, Salmi MF, Najib MA, Norhayati MN, et al. (4 January 2022). [\"Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis\"](https:\/\/doi.org\/10.3390%2Fdiagnostics12010110). *Diagnostics*. **12** (1): 110. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.3390\/diagnostics12010110](https:\/\/doi.org\/10.3390%2Fdiagnostics12010110). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8774565](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8774565). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35054277](https:\/\/pubmed.ncbi.nlm.nih.gov\/35054277).\n4. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-6)\n   Brümmer LE, Katzenschlager S, McGrath S, Schmitz S, Gaeddert M, Erdmann C, et al. (26 May 2022). [\"Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors\"](https:\/\/doi.org\/10.1371%2Fjournal.pmed.1004011). *PLOS Med*. **19** (5) e1004011. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1371\/journal.pmed.1004011](https:\/\/doi.org\/10.1371%2Fjournal.pmed.1004011). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [9187092](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9187092). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35617375](https:\/\/pubmed.ncbi.nlm.nih.gov\/35617375).\n5. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-1) [***c***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-2) [***d***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-3) [***e***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-4) [***f***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-5) [***g***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-6)\n   Tapari A, Braliou GG, Papaefthimiou M, Mavriki H, Kontou PI, Nikolopoulos GK, et al. (4 June 2022). [\"Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis\"](https:\/\/doi.org\/10.3390%2Fdiagnostics12061388). *Diagnostics*. **12** (6): 1388. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.3390\/diagnostics12061388](https:\/\/doi.org\/10.3390%2Fdiagnostics12061388). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [9221910](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9221910). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [35741198](https:\/\/pubmed.ncbi.nlm.nih.gov\/35741198).\n6. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Pecoraro2022_7-0)**\n   Pecoraro V, Negro A, Pirotti T, Trenti T (2022). [\"Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis\"](https:\/\/doi.org\/10.1111%2Feci.13706). *Eur J Clin Invest*. **52** (2) e13706. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1111\/eci.13706](https:\/\/doi.org\/10.1111%2Feci.13706). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8646643](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8646643). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [34741305](https:\/\/pubmed.ncbi.nlm.nih.gov\/34741305).\n7. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Pu2022_8-0)**\n   Pu R, Liu S, Ren X, Shi D, Ba Y, Huo Y, et al. (2022). [\"The screening value of RT-LAMP and RT-PCR in the diagnosis of COVID-19: systematic review and meta-analysis\"](https:\/\/doi.org\/10.1016%2Fj.jviromet.2021.114392). *J Virol Methods*. **300** 114392. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1016\/j.jviromet.2021.114392](https:\/\/doi.org\/10.1016%2Fj.jviromet.2021.114392). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [8629515](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8629515). [PMID](https:\/\/en.wikipedia.org\/wiki\/PMID_\$identifier\$ \"PMID (identifier)\") [34856308](https:\/\/pubmed.ncbi.nlm.nih.gov\/34856308).\n8. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Oxford2020_10-0)**\n   [\"Oxford University and PHE confirm lateral flow tests show high specificity and are effective at identifying most individuals who are infectious\"](https:\/\/www.ox.ac.uk\/news\/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are). *Oxford University*. 11 November 2020. [Archived](https:\/\/web.archive.org\/web\/20210717053744\/https:\/\/www.ox.ac.uk\/news\/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are) from the original on 17 July 2021. Retrieved 19 May 2021.\n9. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Guglielmi2020_11-0)**\n   Guglielmi G (2020). [\"Fast coronavirus tests: what they can and can't do\"](https:\/\/doi.org\/10.1038%2Fd41586-020-02661-2). *Nature*. **585** (7826): 496–498\\. [Bibcode](https:\/\/en.wikipedia.org\/wiki\/Bibcode_\$identifier\$ \"Bibcode (identifier)\"):[2020Natur.585..496G](https:\/\/ui.adsabs.harvard.edu\/abs\/2020Natur.585..496G). [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1038\/d41586-020-02661-2](https:\/\/doi.org\/10.1038%2Fd41586-020-02661-2). 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Retrieved 8 July 2022.\n11. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-NZ2022_13-0)**\n    [\"Case definition and clinical testing guidelines for COVID-19\"](https:\/\/web.archive.org\/web\/20220709053911\/https:\/\/www.health.govt.nz\/covid-19-novel-coronavirus\/covid-19-information-health-professionals\/case-definition-and-clinical-testing-guidelines-covid-19). *Ministry of Health NZ*. [New Zealand Ministry of Health – Manatū Hauora](https:\/\/en.wikipedia.org\/wiki\/Ministry_of_Health_\$New_Zealand\$ \"Ministry of Health (New Zealand)\"). 30 June 2022. Archived from [the original](https:\/\/www.health.govt.nz\/covid-19-novel-coronavirus\/covid-19-information-health-professionals\/case-definition-and-clinical-testing-guidelines-covid-19) on 9 July 2022. Retrieved 8 July 2022.\n12. ^ [***a***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Paltiel2020_14-0) [***b***](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Paltiel2020_14-1)\n    Paltiel AD, Zheng A, Walensky RP (2020). [\"Assessment of SARS-CoV-2 Screening Strategies to Permit the Safe Reopening of College Campuses in the United States\"](https:\/\/doi.org\/10.1001%2Fjamanetworkopen.2020.16818). *JAMA Netw Open*. **3** (7): e2016818. [doi](https:\/\/en.wikipedia.org\/wiki\/Doi_\$identifier\$ \"Doi (identifier)\"):[10\\.1001\/jamanetworkopen.2020.16818](https:\/\/doi.org\/10.1001%2Fjamanetworkopen.2020.16818). [PMC](https:\/\/en.wikipedia.org\/wiki\/PMC_\$identifier\$ \"PMC (identifier)\") [7395236](https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7395236). 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Retrieved 10 July 2022.\n101. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-Arizton2022_103-0)**\n     [\"COVID-19 Rapid Antigen Test Kits Market - Global Outlook & Forecast 2022-2027\"](https:\/\/www.arizton.com\/market-reports\/covid-19-rapid-antigen-test-kit-market). Arizton Advisory & Intelligence. June 2022. [Archived](https:\/\/web.archive.org\/web\/20220710233516\/https:\/\/www.arizton.com\/market-reports\/covid-19-rapid-antigen-test-kit-market) from the original on 10 July 2022. Retrieved 10 July 2022.\n102. **[^](https:\/\/en.wikipedia.org\/wiki\/COVID-19_rapid_antigen_test#cite_ref-MarketStudyReport2021_104-0)**\n     [\"Global COVID-19 Antigen Test Market Size study, by Product & Service (Platforms, Reagents & Kits and Services), by End-Use (Clinics & Hospitals, Home Care, Diagnostic Labs and Others) and Regional Forecasts 2021–2027\"](https:\/\/web.archive.org\/web\/20220815044715\/https:\/\/www.marketstudyreport.com\/reports\/global-covid-19-antigen-test-market-size-research). Market Study Report. 17 July 2021. Archived from [the original](https:\/\/www.marketstudyreport.com\/reports\/global-covid-19-antigen-test-market-size-research) on 15 August 2022. Retrieved 10 July 2022.","meta_canonical":null}

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Boilerpipe Text	From Wikipedia, the free encyclopedia COVID-19 rapid antigen test Negative (left, showing Control line) and positive (right, showing Control and Test lines) results Synonyms SARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test [ a ] Purpose To diagnose SARS-CoV-2 infections ( COVID-19 ) LOINC 94558-4 , 95209-3 , 96119-3 , 97097-0 COVID-19 rapid antigen tests or RAT s, also frequently called COVID-19 lateral flow tests or LFT s, are rapid antigen tests used to detect SARS-CoV-2 infection ( COVID-19 ). They are quick to implement with minimal training, cost a fraction of other forms of COVID-19 testing , and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches. [ 1 ] Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret[s] their test result themselves". [ 2 ] False positives are very rare; the tests' specificity is 98%-99%. [ 3 ] [ 4 ] [ 5 ] However, the tests have a sensitivity of 70%-72%, [ 3 ] [ 4 ] [ 5 ] which is lower than COVID-19 polymerase chain reaction (PCR) tests' sensitivity of 88%-96%. [ 6 ] [ 7 ] [ b ] Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the viral load is higher. [ 3 ] [ 4 ] [ 5 ] [ 8 ] [ 9 ] COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The World Health Organization (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a "confirmed case of SARS-CoV-2 infection" in two ways. [ 10 ] First, the person with a positive Antigen-RDT could meet a "probable case definition" such as having recent loss of smell or taste without any known cause, or could meet certain "suspect criteria" such as having a severe acute respiratory illness. [ 10 ] Second, the person with a positive Antigen-RDT could be asymptomatic but a "contact of a probable or confirmed case." [ 10 ] Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a "confirmed case." [ 11 ] Between 2020 and 2021, studies using mathematical models estimated the benefit of frequent RATs in screening populations for COVID-19. Paltiel et al studied a hypothetical college campus with 5000 students. [ 12 ] Screening all students every two days with a "low-sensitivity, high-specificity test" (such as a RAT) would be able to control an outbreak of COVID-19. [ 12 ] Mina et al theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would "capture most infections while they are still infectious." [ 13 ] The quick results of RATs would serve to limit asymptomatic spread. [ 13 ] Larremore et al simulated various COVID-19 population screening strategies. [ 14 ] The researchers found that "effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity." [ 14 ] In addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters. [ 15 ] Furthermore, following the closure of national borders in Europe following the emergence of the Alpha variant just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food, [ 16 ] effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test. [ 17 ] [ 18 ] Médecins Sans Frontières strongly endorsed the use of rapid tests in lower- and middle-income countries, noting "COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level". [ 19 ] Use for "return to normal" [ edit ] Spain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020, [ 20 ] and a free music concert held in Barcelona for individuals who took a rapid test. [ 21 ] A similar approach was taken in Albania to enable music festivals. [ 22 ] However, many experts were unsure of this approach believing that "rapid tests are not the solution to restart normal life" [ 23 ] but might be used in conjunction with other infection control techniques. [ 24 ] A certification of quality for a COVID-19 rapid antigen home test. False negatives (low sensitivity) [ edit ] Although the specificity of RATs are high (98%-99%), [ 3 ] [ 4 ] [ 5 ] in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative. [ 25 ] [ 26 ] [ 27 ] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%. [ 3 ] [ 4 ] [ 5 ] In one systematic review, the range of sensitivities across studies was 37%-90%. [ 3 ] As the World Health Organization (WHO) recommends RATs with "≥ 80% sensitivity", [ 28 ] many RATs do not meet the WHO recommendation. In the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%). [ 3 ] [ 4 ] [ 5 ] RATs were more sensitive when samples had more viral load, as measured by a low PCR "cycle threshold," and less sensitive when the samples had less viral load. [ 3 ] [ 4 ] [ 5 ] A 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs. [ 29 ] It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%. [ 29 ] Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%. [ 29 ] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19. [ 29 ] Potential for false negative results due to new variants [ edit ] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant . The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours Public Health England laboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the capsid protein and not the spike protein . [ 30 ] Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold. [ 31 ] Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021. [ 31 ] A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the Delta variant and 69.6%-78.3% for the Omicron variant across a range of viral loads ; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%. [ 32 ] False positive results when instructions not followed [ edit ] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be false positive . Beginning in December 2020, TikTok videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results. [ 33 ] Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended buffer solution produced false positives. [ 34 ] In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions. [ 34 ] Slow deployment and uptake [ edit ] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available. [ 35 ] Toxicity of components [ edit ] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used. [ 36 ] On 24 February 2022, Health Canada issued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives [ 37 ] sodium azide and ProClin. [ 38 ] An antigen is a foreign molecule or molecular structure that can cause an immune response . COVID-19 rapid antigen tests (RATs) detect antigenic proteins on the surface of or in the interior of the SARS-CoV-2 coronavirus . Of the COVID-19 RATs that had received an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) by January 2022, all detected nucleocapsid proteins, and one also detected the receptor-binding domain of the coronavirus spike protein . [ 39 ] : Table S1 Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins. [ 40 ] Rapid antigen test functioning by lateral flow assay . A typical COVID-19 RAT is a lateral flow test (LFT). [ 39 ] : Table S1 [ 41 ] For an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip. [ 42 ] [ 43 ] The liquid is pulled through the strip by wicking ( capillary action ), encountering different chemically-enhanced regions embedded within the strip. First, at a "conjugate pad," soluble antibodies with gold nanoparticles are picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample. [ 41 ] Then, at the test line (which may be labelled "T"), antibodies specific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles. [ 41 ] Finally at the control line (which may be labelled "C"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles. [ 41 ] If there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test. [ 41 ] [ 42 ] [ 43 ] History of development and deployment [ edit ] COVID-19 rapid test being administered in Rwanda In May 2020, the US Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by Quidel . [ 44 ] In August 2020, the United States Department of Health and Human Services announced that the US government would be purchasing 150 million BinaxNOW RATs produced by Abbott Laboratories "to expand strategic, evidence-based testing." [ 45 ] Later the agency announced that 100 million of the tests were to be sent to governors to use "at their discretion," for example to reopen schools. [ 46 ] By September 2020, it was reported that the United Kingdom's Moonshot program would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19. [ 47 ] In that month, the World Health Organization (WHO) released interim guidance on COVID-19 "antigen-detecting rapid diagnostic tests" (Ag-RDTs) including recommendations for their use, selection, and implementation. [ 48 ] The interim guidance noted that Ag-RDTs were easier to implement and less expensive than nucleic acid amplification tests (NAATs). [ 48 ] The World Health Organization (WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases. [ 48 ] Health Canada approved its first COVID-19 RAT in October 2020, the Abbott Panbio test. [ 49 ] As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs. [ 50 ] [ 51 ] RATs began to be rolled out across Portuguese schools and care homes. [ 52 ] One of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by Public Health England and University of Oxford , with a preliminary report released in November 2020. [ 53 ] The researchers undertook an evaluation of 64 LFDs that proceeded in several phases. [ 54 ] Of the four LFDs with "desirable performance characteristics," one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%. [ 54 ] Contents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system. On 2 November 2020, Slovakia became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD Biosensor antigen test and performed swabbing on the population. [ 55 ] [ 56 ] Two research studies on the Slovakia experience were published in early 2021, one by professor Martin Kahanec from Central European University and his coauthors and another one by Martin Pavelka from the London School of Hygiene & Tropical Medicine and his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks. [ 1 ] [ 57 ] The United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the Prime Minister , Boris Johnson , started city-wide screening of Liverpool as part of the accelerated technology evaluation. [ 58 ] [ 59 ] Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at Durham University , who had the infrastructure and expertise to manage the rapid test programme, [ 60 ] but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas. [ 61 ] Rapid tests were also implemented within the National Health Service (NHS) for staff to reduce possible transmission to patients, [ 62 ] local authorities [ 63 ] and care homes to enable visits to visit residents. [ 64 ] [ 65 ] On 18 November 2020, Wales completed the first whole borough testing at Merthyr Tydfil . [ 66 ] [ 67 ] Global efforts to step up evaluations of rapid tests were initiated by the World Health Organization (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the Bill and Melinda Gates Foundation that limited costs for low- and middle-income countries. [ 68 ] [ 69 ] Austria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene). [ 70 ] [ 71 ] By the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands, [ 72 ] the United Kingdom, [ 73 ] and the US. [ 74 ] These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada, [ 75 ] travel hubs in Indonesia, [ 76 ] and across India. [ 77 ] Professor William A. Haseltine of Harvard said that "rapid, self-administered testing could stem the ever-surging tide of disease and death." [ 78 ] However, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the $900 billion in COVID-19 relief contained within the Consolidated Appropriations Act, 2021 . The bill was criticized for not specifically supporting COVID rapid self-tests. [ 79 ] Meanwhile, the FDA authorized the Abbott BinaxNOW RAT "for prescription use at home." [ 80 ] [ 81 ] Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume. [ 82 ] In the UK in December 2020, the Medicines and Healthcare products Regulatory Agency approved the Innova rapid test for self-testing of asymptomatic people. [ 83 ] The United Kingdom's chief clinical medic, Dr Susan Hopkins , noted that rapid tests provided a means to find "people that...we couldn't otherwise find". [ 84 ] Noting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the European Commission (EC) met in December 2020 and developed a common European framework for "use, validation and mutual recognition of rapid tests", committing 100 million euros for the purchase of tests from Roche and Abbott . [ 85 ] Stella Kyriakides , commissioner for Health and Food Safety, said "Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic." [ 85 ] By January 2021, the Council of the European Union advocated greater use of rapid tests, noting that "should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered." [ 86 ] In the US, newly inaugurated US president Joe Biden released a national strategy for COVID-19 that pledged to "fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available." [ 87 ] In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription. [ 88 ] Innova voluntarily launched a Class I recall in the US of more than 77,000 of its RATs in April 2021. [ 89 ] Two months later, the FDA warned Americans to stop using the test because it had "significant concerns that the performance of the test has not been adequately established." [ 89 ] A week after the FDA's warning about the Innova test, UK's Medicines and Healthcare products Regulatory Agency (MHRA) cleared the rapid diagnostic's use and extended its authorization. [ 90 ] In October 2021, the World Health Organization (WHO) updated its interim guidance on Ag-RDTs. [ 28 ] Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage. [ 28 ] Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of "higher-than-acceptable false positive test results for SARS-CoV-2". [ 91 ] In December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs. [ 92 ] In response, Dr Leana Wen was quoted as saying that the number of tests "does not come even close to what's needed." [ 92 ] US president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution. [ 93 ] In March 2022, the World Health Organization (WHO) issued interim guidance on self-testing with Ag-RDTs. [ 2 ] The WHO made a strong recommendation that COVID-19 Ag-RDT self-testing "should be offered in addition to professionally administered testing services." [ 2 ] An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs. [ 94 ] In October 2024, the US Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. [ 95 ] The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). [ 95 ] The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu). [ 95 ] This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. [ 95 ] Other OTC flu/COVID tests are available under emergency use authorization. [ 95 ] Costs and cost-effectiveness [ edit ] In late 2020, it was noted that in the US RATs cost US$ 5-$23, in contrast with PCR tests which cost at least $75. [ 50 ] In a Danish study published in 2021, RATs cost about $5.70 per test, as opposed to PCRs at $10.80 per test. [ 96 ] A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine. [ 97 ] A 2021 study concluded that if the US is willing to pay $100,000 per year of life lost averted, then weekly or monthly testing of the population using RATs is likely to be cost-effective . [ 98 ] Another 2021 study estimated incremental cost-effectiveness ratios of "$7890 per infection averted and $1 430 000 per death averted" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period. [ 99 ] Global market value [ edit ] Estimates of value of the worldwide market for RATs vary. One estimate was that the market size was $28 billion in 2021 with a compound annual growth rate (CAGR) of -21.7%, leading to a size of $14 billion in 2028. [ 100 ] A second estimate suggested that the market value was $4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of $743 million in 2027. [ 101 ] A third estimate found a value of $5.3 billion in 2020, which was "anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027." [ 102 ] ^ "Point of care test" and "rapid test" could refer to "rapid antigen test" but could also refer to tests that use PCR or other technologies. ^ The study by Pecoraro et al found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88. ^ a b ^ a b c Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report). World Health Organization (WHO). 9 March 2022. hdl : 10665/352350 . WHO/2019-nCoV/Ag-RDTs/Self_testing/2022.1. ^ a b c d e f g h Khalid MF, Selvam K, Jeffry AJ, Salmi MF, Najib MA, Norhayati MN, et al. (4 January 2022). 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Markdown	[Jump to content](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#bodyContent) Main menu Main menu move to sidebar hide Navigation - [Main page](https://en.wikipedia.org/wiki/Main_Page "Visit the main page [z]") - [Contents](https://en.wikipedia.org/wiki/Wikipedia:Contents "Guides to browsing Wikipedia") - [Current events](https://en.wikipedia.org/wiki/Portal:Current_events "Articles related to current events") - [Random article](https://en.wikipedia.org/wiki/Special:Random "Visit a randomly selected article [x]") - [About Wikipedia](https://en.wikipedia.org/wiki/Wikipedia:About "Learn about Wikipedia and how it works") - [Contact us](https://en.wikipedia.org/wiki/Wikipedia:Contact_us "How to contact Wikipedia") Contribute - [Help](https://en.wikipedia.org/wiki/Help:Contents "Guidance on how to use and edit Wikipedia") - [Learn to edit](https://en.wikipedia.org/wiki/Help:Introduction "Learn how to edit Wikipedia") - [Community portal](https://en.wikipedia.org/wiki/Wikipedia:Community_portal "The hub for editors") - [Recent changes](https://en.wikipedia.org/wiki/Special:RecentChanges "A list of recent changes to Wikipedia [r]") - [Upload file](https://en.wikipedia.org/wiki/Wikipedia:File_upload_wizard "Add images or other media for use on Wikipedia") - [Special pages](https://en.wikipedia.org/wiki/Special:SpecialPages "A list of all special pages [q]") [![](https://en.wikipedia.org/static/images/icons/enwiki-25.svg) ![Wikipedia](https://en.wikipedia.org/static/images/mobile/copyright/wikipedia-wordmark-en-25.svg) ![The Free Encyclopedia](https://en.wikipedia.org/static/images/mobile/copyright/wikipedia-tagline-en-25.svg)](https://en.wikipedia.org/wiki/Main_Page) [Search](https://en.wikipedia.org/wiki/Special:Search "Search Wikipedia [f]") Appearance - [Donate](https://donate.wikimedia.org/?wmf_source=donate&wmf_medium=sidebar&wmf_campaign=en.wikipedia.org&uselang=en) - [Create account](https://en.wikipedia.org/w/index.php?title=Special:CreateAccount&returnto=COVID-19+rapid+antigen+test "You are encouraged to create an account and log in; however, it is not mandatory") - [Log in](https://en.wikipedia.org/w/index.php?title=Special:UserLogin&returnto=COVID-19+rapid+antigen+test "You're encouraged to log in; however, it's not mandatory. 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[o]") ## Contents move to sidebar hide - [(Top)](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test) - [1 Uses](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Uses) Toggle Uses subsection - [1\.1 Use in diagnosis](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Use_in_diagnosis) - [1\.2 Use in screening](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Use_in_screening) - [1\.3 Humanitarian uses](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Humanitarian_uses) - [1\.4 Use for "return to normal"](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Use_for_"return_to_normal") - [2 Concerns about use](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Concerns_about_use) Toggle Concerns about use subsection - [2\.1 False negatives (low sensitivity)](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#False_negatives_$low_sensitivity$) - [2\.2 Potential for false negative results due to new variants](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Potential_for_false_negative_results_due_to_new_variants) - [2\.3 False positive results when instructions not followed](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#False_positive_results_when_instructions_not_followed) - [2\.4 Slow deployment and uptake](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Slow_deployment_and_uptake) - [2\.5 Toxicity of components](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Toxicity_of_components) - [3 Methods](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Methods) - [4 History of development and deployment](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#History_of_development_and_deployment) Toggle History of development and deployment subsection - [4\.1 2020](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#2020) - [4\.2 2021](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#2021) - [4\.3 2022](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#2022) - [4\.4 2024](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#2024) - [5 Economic aspects](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Economic_aspects) Toggle Economic aspects subsection - [5\.1 Costs and cost-effectiveness](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Costs_and_cost-effectiveness) - [5\.2 Global market value](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Global_market_value) - [6 Notes](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#Notes) - [7 References](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#References) Toggle the table of contents # COVID-19 rapid antigen test 27 languages - [العربية](https://ar.wikipedia.org/wiki/%D8%A7%D9%84%D8%A7%D8%AE%D8%AA%D8%A8%D8%A7%D8%B1_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D8%B6%D8%AF_%D8%A7%D9%84%D8%B3%D8%B1%D9%8A%D8%B9_%D9%84%D9%83%D9%88%D9%81%D9%8A%D8%AF-19 "الاختبار المستضد السريع لكوفيد-19 – Arabic") - [Български](https://bg.wikipedia.org/wiki/%D0%91%D1%8A%D1%80%D0%B7_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD%D0%B5%D0%BD_%D1%82%D0%B5%D1%81%D1%82_COVID-19 "Бърз антигенен тест COVID-19 – Bulgarian") - [Čeština](https://cs.wikipedia.org/wiki/Rychl%C3%BD_antigenn%C3%AD_test_na_covid-19 "Rychlý antigenní test na covid-19 – Czech") - [Ελληνικά](https://el.wikipedia.org/wiki/COVID-19_%CE%B3%CF%81%CE%AE%CE%B3%CE%BF%CF%81%CE%B7_%CE%B4%CE%BF%CE%BA%CE%B9%CE%BC%CE%AE_%CE%B1%CE%BD%CF%84%CE%B9%CE%B3%CF%8C%CE%BD%CE%BF%CF%85 "COVID-19 γρήγορη δοκιμή αντιγόνου – Greek") - [Español](https://es.wikipedia.org/wiki/Prueba_r%C3%A1pida_de_ant%C3%ADgeno_COVID-19 "Prueba rápida de antígeno COVID-19 – Spanish") - [Eesti](https://et.wikipedia.org/wiki/COVID-19_antigeeni_kiirtestid "COVID-19 antigeeni kiirtestid – Estonian") - [فارسی](https://fa.wikipedia.org/wiki/%D8%A2%D8%B2%D9%85%D8%A7%DB%8C%D8%B4_%D8%B3%D8%B1%DB%8C%D8%B9_%D8%A2%D9%86%D8%AA%DB%8C%E2%80%8C%DA%98%D9%86_%DA%A9%D9%88%D9%88%DB%8C%D8%AF_%DB%B1%DB%B9 "آزمایش سریع آنتی‌ژن کووید ۱۹ – Persian") - [Suomi](https://fi.wikipedia.org/wiki/COVID-19-pikatestit "COVID-19-pikatestit – Finnish") - [Galego](https://gl.wikipedia.org/wiki/Proba_r%C3%A1pida_de_ant%C3%ADxeno_COVID-19 "Proba rápida de antíxeno COVID-19 – Galician") - [Hausa](https://ha.wikipedia.org/wiki/Gwajin_COVID-19_Cikin_Saurin_Antigen "Gwajin COVID-19 Cikin Saurin Antigen – Hausa") - [Hrvatski](https://hr.wikipedia.org/wiki/Brzi_testovi_na_antigen_COVID-19 "Brzi testovi na antigen COVID-19 – Croatian") - [Magyar](https://hu.wikipedia.org/wiki/Covid19-antig%C3%A9n_gyorsteszt "Covid19-antigén gyorsteszt – Hungarian") - [Bahasa Indonesia](https://id.wikipedia.org/wiki/Tes_cepat_antigen_Covid-19 "Tes cepat antigen Covid-19 – Indonesian") - [Italiano](https://it.wikipedia.org/wiki/Test_antigenico_rapido_per_SARS-CoV-2 "Test antigenico rapido per SARS-CoV-2 – Italian") - [日本語](https://ja.wikipedia.org/wiki/%E6%8A%97%E5%8E%9F%E6%A4%9C%E6%9F%BB%E3%82%AD%E3%83%83%E3%83%88 "抗原検査キット – Japanese") - [ಕನ್ನಡ](https://kn.wikipedia.org/wiki/%E0%B2%95%E0%B3%8B%E0%B2%B5%E0%B2%BF%E0%B2%A1%E0%B3%8D-%E0%B3%A7%E0%B3%AF/%E0%B2%95%E0%B3%8D%E0%B2%B7%E0%B2%BF%E0%B2%AA%E0%B3%8D%E0%B2%B0_%E0%B2%AA%E0%B3%8D%E0%B2%B0%E0%B2%A4%E0%B2%BF%E0%B2%9C%E0%B2%A8%E0%B2%95_%E0%B2%AA%E0%B2%B0%E0%B3%80%E0%B2%95%E0%B3%8D%E0%B2%B7%E0%B3%86%E0%B2%97%E0%B2%B3%E0%B3%81 "ಕೋವಿಡ್-೧೯/ಕ್ಷಿಪ್ರ ಪ್ರತಿಜನಕ ಪರೀಕ್ಷೆಗಳು – Kannada") - [한국어](https://ko.wikipedia.org/wiki/%EC%BD%94%EB%A1%9C%EB%82%9819_%EC%8B%A0%EC%86%8D%ED%95%AD%EC%9B%90%EA%B2%80%EC%82%AC "코로나19 신속항원검사 – Korean") - [Latviešu](https://lv.wikipedia.org/wiki/COVID-19_%C4%81trais_antig%C4%93nu_tests "COVID-19 ātrais antigēnu tests – Latvian") - [Nederlands](https://nl.wikipedia.org/wiki/COVID-19-antigeen-sneltests "COVID-19-antigeen-sneltests – Dutch") - [Português](https://pt.wikipedia.org/wiki/Teste_r%C3%A1pido_de_antig%C3%A9nios_COVID-19 "Teste rápido de antigénios COVID-19 – Portuguese") - [Română](https://ro.wikipedia.org/wiki/Teste_rapide_de_antigeni_COVID-19 "Teste rapide de antigeni COVID-19 – Romanian") - [Русский](https://ru.wikipedia.org/wiki/%D0%91%D1%8B%D1%81%D1%82%D1%80%D1%8B%D0%B9_%D1%82%D0%B5%D1%81%D1%82_%D0%BD%D0%B0_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD_COVID-19 "Быстрый тест на антиген COVID-19 – Russian") - [Slovenčina](https://sk.wikipedia.org/wiki/R%C3%BDchly_antig%C3%A9nov%C3%BD_test_COVID-19 "Rýchly antigénový test COVID-19 – Slovak") - [Slovenščina](https://sl.wikipedia.org/wiki/Hitri_antigenski_test_COVID-19 "Hitri antigenski test COVID-19 – Slovenian") - [Українська](https://uk.wikipedia.org/wiki/%D0%95%D0%BA%D1%81%D0%BF%D1%80%D0%B5%D1%81-%D1%82%D0%B5%D1%81%D1%82%D0%B8_%D0%BD%D0%B0_%D0%B0%D0%BD%D1%82%D0%B8%D0%B3%D0%B5%D0%BD_COVID-19 "Експрес-тести на антиген COVID-19 – Ukrainian") - [اردو](https://ur.wikipedia.org/wiki/%D8%B1%DB%8C%D8%A7%D9%BE%DA%88_%D8%A7%DB%8C%D9%86%D9%B9%DB%8C%D8%AC%D9%86_%D9%B9%DB%8C%D8%B3%D9%B9_$%DA%A9%D9%88%D9%88%DA%88_19$ "ریاپڈ اینٹیجن ٹیسٹ (کووڈ 19) – Urdu") - [中文](https://zh.wikipedia.org/wiki/2019%E5%86%A0%E7%8B%80%E7%97%85%E6%AF%92%E7%97%85%E5%BF%AB%E9%80%9F%E6%8A%97%E5%8E%9F%E6%AA%A2%E6%B8%AC "2019冠狀病毒病快速抗原檢測 – Chinese") [Edit links](https://www.wikidata.org/wiki/Special:EntityPage/Q106915773#sitelinks-wikipedia "Edit interlanguage links") - [Article](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test "View the content page [c]") - [Talk](https://en.wikipedia.org/wiki/Talk:COVID-19_rapid_antigen_test "Discuss improvements to the content page [t]") English - 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[Wikimedia Commons](https://commons.wikimedia.org/wiki/Category:COVID-19_rapid_antigen_tests) - [Wikidata item](https://www.wikidata.org/wiki/Special:EntityPage/Q106915773 "Structured data on this page hosted by Wikidata [g]") Appearance move to sidebar hide From Wikipedia, the free encyclopedia Diagnostic test for a SARS-CoV-2 infection Medical diagnostic method \| COVID-19 rapid antigen test \| \| \|---\|---\| \| [![](https://upload.wikimedia.org/wikipedia/commons/thumb/6/6c/Lateral_flow_covid_19_negative_and_positive_test.jpg/250px-Lateral_flow_covid_19_negative_and_positive_test.jpg)](https://en.wikipedia.org/wiki/File:Lateral_flow_covid_19_negative_and_positive_test.jpg)Negative (left, showing Control line) and positive (right, showing Control and Test lines) results \| \| \| [Synonyms](https://en.wikipedia.org/wiki/Synonym "Synonym") \| SARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test[\[a\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-1) \| \| Purpose \| To diagnose [SARS-CoV-2](https://en.wikipedia.org/wiki/SARS-CoV-2 "SARS-CoV-2") infections ([COVID-19](https://en.wikipedia.org/wiki/COVID-19 "COVID-19")) \| \| [LOINC](https://en.wikipedia.org/wiki/LOINC "LOINC") \| [94558-4](https://s.details.loinc.org/LOINC/94558-4.html?sections=Comprehensive), [95209-3](https://s.details.loinc.org/LOINC/95209-3.html?sections=Comprehensive), [96119-3](https://s.details.loinc.org/LOINC/96119-3.html?sections=Comprehensive), [97097-0](https://s.details.loinc.org/LOINC/97097-0.html?sections=Comprehensive) \| COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 [lateral flow tests](https://en.wikipedia.org/wiki/Lateral_flow_test "Lateral flow test") or LFTs, are [rapid antigen tests](https://en.wikipedia.org/wiki/Rapid_antigen_test "Rapid antigen test") used to detect [SARS-CoV-2](https://en.wikipedia.org/wiki/Severe_acute_respiratory_syndrome_coronavirus_2 "Severe acute respiratory syndrome coronavirus 2") infection ([COVID-19](https://en.wikipedia.org/wiki/COVID-19 "COVID-19")). They are quick to implement with minimal training, cost a fraction of other forms of [COVID-19 testing](https://en.wikipedia.org/wiki/COVID-19_testing "COVID-19 testing"), and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.[\[1\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2) Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret\[s\] their test result themselves".[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) [False positives](https://en.wikipedia.org/wiki/False_positive "False positive") are very rare; the tests' [specificity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") is 98%-99%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) However, the tests have a [sensitivity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") of 70%-72%,[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) which is lower than COVID-19 [polymerase chain reaction](https://en.wikipedia.org/wiki/Polymerase_chain_reaction "Polymerase chain reaction") (PCR) tests' sensitivity of 88%-96%.[\[6\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pecoraro2022-7)[\[7\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pu2022-8)[\[b\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-9) Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the [viral load](https://en.wikipedia.org/wiki/Viral_load "Viral load") is higher.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)[\[8\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Oxford2020-10)[\[9\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Guglielmi2020-11) ## Uses \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=1 "Edit section: Uses")\] ### Use in diagnosis \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=2 "Edit section: Use in diagnosis")\] COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a "confirmed case of SARS-CoV-2 infection" in two ways.[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) First, the person with a positive Antigen-RDT could meet a "probable case definition" such as having recent loss of smell or taste without any known cause, or could meet certain "suspect criteria" such as having a severe acute respiratory illness.[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Second, the person with a positive Antigen-RDT could be asymptomatic but a "contact of a probable or confirmed case."[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a "confirmed case."[\[11\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NZ2022-13) ### Use in screening \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=3 "Edit section: Use in screening")\] Between 2020 and 2021, studies using [mathematical models](https://en.wikipedia.org/wiki/Mathematical_model "Mathematical model") estimated the benefit of frequent RATs in [screening](https://en.wikipedia.org/wiki/Screening_$medicine$ "Screening (medicine)") populations for COVID-19. Paltiel et al studied a hypothetical college campus with 5000 students.[\[12\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) Screening all students every two days with a "low-sensitivity, high-specificity test" (such as a RAT) would be able to control an outbreak of COVID-19.[\[12\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) [Mina](https://en.wikipedia.org/wiki/Michael_Mina_$epidemiologist$ "Michael Mina (epidemiologist)") et al theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would "capture most infections while they are still infectious."[\[13\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) The quick results of RATs would serve to limit asymptomatic spread.[\[13\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) Larremore et al simulated various COVID-19 population screening strategies.[\[14\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) The researchers found that "effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity."[\[14\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) ### Humanitarian uses \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=4 "Edit section: Humanitarian uses")\] In addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.[\[15\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-17) Furthermore, following the closure of national borders in Europe following the emergence of the [Alpha variant](https://en.wikipedia.org/wiki/Alpha_variant "Alpha variant") just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,[\[16\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-18) effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.[\[17\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-19)[\[18\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-20) [Médecins Sans Frontières](https://en.wikipedia.org/wiki/M%C3%A9decins_Sans_Fronti%C3%A8res "Médecins Sans Frontières") strongly endorsed the use of rapid tests in lower- and middle-income countries, noting "COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level".[\[19\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-21) ### Use for "return to normal" \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=5 "Edit section: Use for \"return to normal\"")\] Spain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,[\[20\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-22) and a free music concert held in [Barcelona](https://en.wikipedia.org/wiki/Barcelona "Barcelona") for individuals who took a rapid test.[\[21\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-23) A similar approach was taken in [Albania](https://en.wikipedia.org/wiki/Albania "Albania") to enable music festivals.[\[22\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-24) However, many experts were unsure of this approach believing that "rapid tests are not the solution to restart normal life"[\[23\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-25) but might be used in conjunction with other infection control techniques.[\[24\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-26) ## Concerns about use \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=6 "Edit section: Concerns about use")\] [![](https://upload.wikimedia.org/wikipedia/commons/thumb/9/90/COVID-19_rapid_antigen_test_Certification.jpg/250px-COVID-19_rapid_antigen_test_Certification.jpg)](https://en.wikipedia.org/wiki/File:COVID-19_rapid_antigen_test_Certification.jpg) A certification of quality for a COVID-19 rapid antigen home test. ### False negatives (low sensitivity) \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=7 "Edit section: False negatives (low sensitivity)")\] Although the [specificity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") of RATs are high (98%-99%),[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) in 2020 RATs were criticized for having a [sensitivity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.[\[25\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Service2020-27)[\[26\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Saxena2020-28)[\[27\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Halliday2020-29) As of 2022, [systematic reviews](https://en.wikipedia.org/wiki/Systematic_review "Systematic review") determined that the pooled sensitivities of RATs were 70%-72%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) In one systematic review, the range of sensitivities across studies was 37%-90%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4) As the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) recommends RATs with "≥ 80% sensitivity",[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) many RATs do not meet the WHO recommendation. In the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) RATs were more sensitive when samples had more viral load, as measured by a low PCR "cycle threshold," and less sensitive when the samples had less viral load.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) A 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) ### Potential for false negative results due to new variants \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=8 "Edit section: Potential for false negative results due to new variants")\] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the [SARS-CoV-2 Alpha variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Alpha_variant "SARS-CoV-2 Alpha variant"). The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours [Public Health England](https://en.wikipedia.org/wiki/Public_Health_England "Public Health England") laboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the [capsid](https://en.wikipedia.org/wiki/Capsid "Capsid") protein and not the [spike protein](https://en.wikipedia.org/wiki/Coronavirus_spike_protein "Coronavirus spike protein").[\[30\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-32) Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.[\[31\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.[\[31\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the [Delta variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Delta_variant "SARS-CoV-2 Delta variant") and 69.6%-78.3% for the [Omicron variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Omicron_variant "SARS-CoV-2 Omicron variant") across a range of [viral loads](https://en.wikipedia.org/wiki/Viral_load "Viral load"); however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.[\[32\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bayart2022-34) ### False positive results when instructions not followed \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=9 "Edit section: False positive results when instructions not followed")\] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be [false positive](https://en.wikipedia.org/wiki/False_positives_and_false_negatives#False_positive_error "False positives and false negatives"). Beginning in December 2020, [TikTok](https://en.wikipedia.org/wiki/TikTok "TikTok") videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.[\[33\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Lorch2022-35) Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended [buffer solution](https://en.wikipedia.org/wiki/Buffer_solution "Buffer solution") produced false positives.[\[34\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.[\[34\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) ### Slow deployment and uptake \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=10 "Edit section: Slow deployment and uptake")\] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.[\[35\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Holliday2021-37) ### Toxicity of components \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=11 "Edit section: Toxicity of components")\] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.[\[36\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-38) On 24 February 2022, [Health Canada](https://en.wikipedia.org/wiki/Health_Canada "Health Canada") issued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives[\[37\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-39) [sodium azide](https://en.wikipedia.org/wiki/Sodium_azide "Sodium azide") and ProClin.[\[38\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-40) ## Methods \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=12 "Edit section: Methods")\] An [antigen](https://en.wikipedia.org/wiki/Antigen "Antigen") is a foreign [molecule](https://en.wikipedia.org/wiki/Molecule "Molecule") or molecular [structure](https://en.wikipedia.org/wiki/Structure "Structure") that can cause an [immune response](https://en.wikipedia.org/wiki/Immune_response "Immune response"). COVID-19 rapid antigen tests (RATs) detect antigenic [proteins](https://en.wikipedia.org/wiki/Protein "Protein") on the surface of or in the interior of the SARS-CoV-2 [coronavirus](https://en.wikipedia.org/wiki/Coronavirus "Coronavirus"). Of the COVID-19 RATs that had received an [emergency use authorization](https://en.wikipedia.org/wiki/Emergency_use_authorization "Emergency use authorization") (EUA) from the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") (FDA) by January 2022, all detected [nucleocapsid](https://en.wikipedia.org/wiki/Nucleocapsid "Nucleocapsid") proteins, and one also detected the receptor-binding domain of the [coronavirus spike protein](https://en.wikipedia.org/wiki/Coronavirus_spike_protein "Coronavirus spike protein").[\[39\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.[\[40\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EUCommonList2020-42) [![](https://upload.wikimedia.org/wikipedia/commons/thumb/d/d3/Lateral_Flow_Assay.jpg/330px-Lateral_Flow_Assay.jpg)](https://en.wikipedia.org/wiki/File:Lateral_Flow_Assay.jpg) Rapid antigen test functioning by [lateral flow assay](https://en.wikipedia.org/wiki/Lateral_flow_assay "Lateral flow assay"). A typical COVID-19 RAT is a [lateral flow test](https://en.wikipedia.org/wiki/Lateral_flow_test "Lateral flow test") (LFT).[\[39\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 [\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) For an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.[\[42\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\[43\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) The liquid is pulled through the strip by wicking ([capillary action](https://en.wikipedia.org/wiki/Capillary_action "Capillary action")), encountering different chemically-enhanced regions embedded within the strip. First, at a "conjugate pad," soluble antibodies with gold [nanoparticles](https://en.wikipedia.org/wiki/Nanoparticle "Nanoparticle") are picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Then, at the test line (which may be labelled "T"), [antibodies](https://en.wikipedia.org/wiki/Antibodies "Antibodies") specific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Finally at the control line (which may be labelled "C"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) If there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)[\[42\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\[43\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) ## History of development and deployment \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=13 "Edit section: History of development and deployment")\] Main article: [Development of COVID-19 tests](https://en.wikipedia.org/wiki/Development_of_COVID-19_tests "Development of COVID-19 tests") ### 2020 \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=14 "Edit section: 2020")\] [![](https://upload.wikimedia.org/wikipedia/commons/thumb/f/f5/Covid-19_rapid_test_in_Rwanda.jpg/330px-Covid-19_rapid_test_in_Rwanda.jpg)](https://en.wikipedia.org/wiki/File:Covid-19_rapid_test_in_Rwanda.jpg) COVID-19 rapid test being administered in Rwanda In May 2020, the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") (FDA) issued the first [emergency use authorization](https://en.wikipedia.org/wiki/Emergency_use_authorization "Emergency use authorization") (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by [Quidel](https://en.wikipedia.org/wiki/Quidel "Quidel").[\[44\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAQuidel2020-46) In August 2020, the [United States Department of Health and Human Services](https://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services "United States Department of Health and Human Services") announced that the US government would be purchasing 150 million BinaxNOW RATs produced by [Abbott Laboratories](https://en.wikipedia.org/wiki/Abbott_Laboratories "Abbott Laboratories") "to expand strategic, evidence-based testing."[\[45\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-HHS2020-47) Later the agency announced that 100 million of the tests were to be sent to governors to use "at their discretion," for example to reopen schools.[\[46\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Blad2020-48) By September 2020, it was reported that the United Kingdom's [Moonshot program](https://en.wikipedia.org/wiki/Operation_Moonshot "Operation Moonshot") would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.[\[47\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Iacobucci2020-49) In that month, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) released interim guidance on COVID-19 "antigen-detecting rapid diagnostic tests" (Ag-RDTs) including recommendations for their use, selection, and implementation.[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The interim guidance noted that Ag-RDTs were easier to implement and less expensive than [nucleic acid](https://en.wikipedia.org/wiki/Nucleic_acid "Nucleic acid") amplification tests (NAATs).[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) [Health Canada](https://en.wikipedia.org/wiki/Health_Canada "Health Canada") approved its first COVID-19 RAT in October 2020, the Abbott Panbio test.[\[49\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tasker2020-51) As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.[\[50\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52)[\[51\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bonislawski2020-53) RATs began to be rolled out across Portuguese schools and care homes.[\[52\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-54) One of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by [Public Health England](https://en.wikipedia.org/wiki/Public_Health_England "Public Health England") and [University of Oxford](https://en.wikipedia.org/wiki/University_of_Oxford "University of Oxford"), with a preliminary report released in November 2020.[\[53\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Oxford2020a-55) The researchers undertook an evaluation of 64 LFDs that proceeded in several phases.[\[54\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) Of the four LFDs with "desirable performance characteristics," one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.[\[54\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) [![](https://upload.wikimedia.org/wikipedia/commons/thumb/e/e7/NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg/250px-NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)](https://en.wikipedia.org/wiki/File:NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg) Contents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system. On 2 November 2020, [Slovakia](https://en.wikipedia.org/wiki/Slovakia "Slovakia") became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD [Biosensor](https://en.wikipedia.org/wiki/Biosensor "Biosensor") antigen test and performed swabbing on the population.[\[55\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-57)[\[56\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-58) Two research studies on the Slovakia experience were published in early 2021, one by professor [Martin Kahanec](https://en.wikipedia.org/w/index.php?title=Martin_Kahanec&action=edit&redlink=1 "Martin Kahanec (page does not exist)") from [Central European University](https://en.wikipedia.org/wiki/Central_European_University "Central European University") and his coauthors and another one by Martin Pavelka from the [London School of Hygiene & Tropical Medicine](https://en.wikipedia.org/wiki/London_School_of_Hygiene_%26_Tropical_Medicine "London School of Hygiene & Tropical Medicine") and his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.[\[1\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2)[\[57\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pavelka2021-59) The United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the [Prime Minister](https://en.wikipedia.org/wiki/Prime_Minister_of_the_United_Kingdom "Prime Minister of the United Kingdom"), [Boris Johnson](https://en.wikipedia.org/wiki/Boris_Johnson "Boris Johnson"), started city-wide screening of [Liverpool](https://en.wikipedia.org/wiki/Liverpool "Liverpool") as part of the accelerated technology evaluation.[\[58\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-60)[\[59\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Littlejohns2020-61) Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at [Durham University](https://en.wikipedia.org/wiki/Durham_University "Durham University"), who had the infrastructure and expertise to manage the rapid test programme,[\[60\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-62) but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[\[61\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-63) Rapid tests were also implemented within the [National Health Service](https://en.wikipedia.org/wiki/National_Health_Service "National Health Service") (NHS) for staff to reduce possible transmission to patients,[\[62\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-64) local authorities [\[63\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-65) and care homes to enable visits to visit residents.[\[64\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-66)[\[65\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-67) On 18 November 2020, [Wales](https://en.wikipedia.org/wiki/Wales "Wales") completed the first whole borough testing at [Merthyr Tydfil](https://en.wikipedia.org/wiki/Merthyr_Tydfil "Merthyr Tydfil").[\[66\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-68)[\[67\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-69) Global efforts to step up evaluations of rapid tests were initiated by the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the [Bill and Melinda Gates Foundation](https://en.wikipedia.org/wiki/Bill_and_Melinda_Gates_Foundation "Bill and Melinda Gates Foundation") that limited costs for low- and middle-income countries.[\[68\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-70)[\[69\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-71) Austria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[\[70\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-72)[\[71\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-73) By the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[\[72\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-74) the United Kingdom,[\[73\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-75) and the US.[\[74\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-76) These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,[\[75\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-77) travel hubs in Indonesia,[\[76\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-78) and across India.[\[77\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-79) Professor [William A. Haseltine](https://en.wikipedia.org/wiki/William_A._Haseltine "William A. Haseltine") of Harvard said that "rapid, self-administered testing could stem the ever-surging tide of disease and death."[\[78\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-80) However, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the \$900 billion in COVID-19 relief contained within the [Consolidated Appropriations Act, 2021](https://en.wikipedia.org/wiki/Consolidated_Appropriations_Act,_2021 "Consolidated Appropriations Act, 2021"). The bill was criticized for not specifically supporting COVID rapid self-tests.[\[79\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-81) Meanwhile, the FDA authorized the Abbott BinaxNOW RAT "for prescription use at home."[\[80\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAAbbott2020-82)[\[81\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Wan2020-83) Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.[\[82\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-84) In the UK in December 2020, the [Medicines and Healthcare products Regulatory Agency](https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency "Medicines and Healthcare products Regulatory Agency") approved the Innova rapid test for self-testing of asymptomatic people.[\[83\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mahase2020-85) The United Kingdom's chief clinical medic, Dr [Susan Hopkins](https://en.wikipedia.org/wiki/Susan_Hopkins "Susan Hopkins"), noted that rapid tests provided a means to find "people that...we couldn't otherwise find".[\[84\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-86) Noting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the [European Commission](https://en.wikipedia.org/wiki/European_Commission "European Commission") (EC) met in December 2020 and developed a common European framework for "use, validation and mutual recognition of rapid tests", committing 100 million euros for the purchase of tests from [Roche](https://en.wikipedia.org/wiki/Hoffmann-La_Roche "Hoffmann-La Roche") and [Abbott](https://en.wikipedia.org/wiki/Abbott_Laboratories "Abbott Laboratories").[\[85\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EC2020-87) [Stella Kyriakides](https://en.wikipedia.org/wiki/Stella_Kyriakides "Stella Kyriakides"), commissioner for Health and Food Safety, said "Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic."[\[85\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EC2020-87) ### 2021 \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=15 "Edit section: 2021")\] By January 2021, the [Council of the European Union](https://en.wikipedia.org/wiki/Council_of_the_European_Union "Council of the European Union") advocated greater use of rapid tests, noting that "should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered."[\[86\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EUCouncil2021-88) In the US, newly inaugurated US president [Joe Biden](https://en.wikipedia.org/wiki/Joe_Biden "Joe Biden") released a national strategy for COVID-19 that pledged to "fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available."[\[87\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Biden2021-89) In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.[\[88\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAOTC2021-90) Innova voluntarily launched a [Class I recall](https://en.wikipedia.org/wiki/FDA_recall_policies#Class_I "FDA recall policies") in the US of more than 77,000 of its RATs in April 2021.[\[89\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) Two months later, the FDA warned Americans to stop using the test because it had "significant concerns that the performance of the test has not been adequately established."[\[89\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) A week after the FDA's warning about the Innova test, UK's [Medicines and Healthcare products Regulatory Agency](https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency "Medicines and Healthcare products Regulatory Agency") (MHRA) cleared the rapid diagnostic's use and extended its authorization.[\[90\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Hale2021-92) In October 2021, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) updated its interim guidance on Ag-RDTs.[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of "higher-than-acceptable false positive test results for SARS-CoV-2".[\[91\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAEllume2021-93) In December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.[\[92\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) In response, Dr [Leana Wen](https://en.wikipedia.org/wiki/Leana_Wen "Leana Wen") was quoted as saying that the number of tests "does not come even close to what's needed."[\[92\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) ### 2022 \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=16 "Edit section: 2022")\] US president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.[\[93\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2022-95) In March 2022, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) issued interim guidance on self-testing with Ag-RDTs.[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) The WHO made a strong recommendation that COVID-19 Ag-RDT self-testing "should be offered in addition to professionally administered testing services."[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.[\[94\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA2022-96) ### 2024 \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=17 "Edit section: 2024")\] In October 2024, the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A\&B Antigen Test.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) Other OTC flu/COVID tests are available under emergency use authorization.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) ## Economic aspects \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=18 "Edit section: Economic aspects")\] ### Costs and cost-effectiveness \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=19 "Edit section: Costs and cost-effectiveness")\] In late 2020, it was noted that in the US RATs cost [US\$](https://en.wikipedia.org/wiki/US$ "US$")5-\$23, in contrast with PCR tests which cost at least \$75.[\[50\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52) In a Danish study published in 2021, RATs cost about \$5.70 per test, as opposed to PCRs at \$10.80 per test.[\[96\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Jakobsen2021-98) A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.[\[97\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Diel2021-99) A 2021 study concluded that if the US is willing to pay \$100,000 per [year of life lost](https://en.wikipedia.org/wiki/Years_of_potential_life_lost "Years of potential life lost") averted, then weekly or monthly testing of the population using RATs is likely to be [cost-effective](https://en.wikipedia.org/wiki/Cost-effectiveness_analysis "Cost-effectiveness analysis").[\[98\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-pmid33549196-100) Another 2021 study estimated [incremental cost-effectiveness ratios](https://en.wikipedia.org/wiki/Incremental_cost-effectiveness_ratio "Incremental cost-effectiveness ratio") of "\$7890 per infection averted and \$1 430 000 per death averted" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.[\[99\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2021-101) ### Global market value \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=20 "Edit section: Global market value")\] Estimates of value of the worldwide market for RATs vary. One estimate was that the market size was \$28 billion in 2021 with a [compound annual growth rate](https://en.wikipedia.org/wiki/Compound_annual_growth_rate "Compound annual growth rate") (CAGR) of -21.7%, leading to a size of \$14 billion in 2028.[\[100\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-MarketReportsWorld2022-102) A second estimate suggested that the market value was \$4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of \$743 million in 2027.[\[101\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Arizton2022-103) A third estimate found a value of \$5.3 billion in 2020, which was "anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027."[\[102\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-MarketStudyReport2021-104) ## Notes \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=21 "Edit section: Notes")\] 1. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-1) "Point of care test" and "rapid test" could refer to "rapid antigen test" but could also refer to tests that use PCR or other technologies. 2. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-9) The study by Pecoraro et al found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88. [Portal](https://en.wikipedia.org/wiki/Wikipedia:Contents/Portals "Wikipedia:Contents/Portals"): - ![icon](https://upload.wikimedia.org/wikipedia/commons/thumb/d/d6/WHO_Rod.svg/20px-WHO_Rod.svg.png) [Medicine](https://en.wikipedia.org/wiki/Portal:Medicine "Portal:Medicine") ## References \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=22 "Edit section: References")\] 1. ^ [*a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-1) Kahanec M, Lafférs L, Schmidpeter B (2021). ["The impact of repeated mass antigen testing for COVID-19 on the prevalence of the disease"](https://doi.org/10.1007%2Fs00148-021-00856-z). J Popul Econ. 34* (4): 1105–1140\. [doi](https://en.wikipedia.org/wiki/Doi_$identifier$ "Doi (identifier)"):[10\.1007/s00148-021-00856-z](https://doi.org/10.1007%2Fs00148-021-00856-z). [PMC](https://en.wikipedia.org/wiki/PMC_$identifier$ "PMC (identifier)") [8241209](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8241209). [PMID](https://en.wikipedia.org/wiki/PMID_$identifier$ "PMID (identifier)") [34219976](https://pubmed.ncbi.nlm.nih.gov/34219976). 2. ^ [*a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-1) [c](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-2) Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report). [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO). 9 March 2022. [hdl](https://en.wikipedia.org/wiki/Hdl_$identifier$ "Hdl (identifier)"):[10665/352350](https://hdl.handle.net/10665%2F352350). WHO/2019-nCoV/Ag-RDTs/Self\_testing/2022.1. 3. ^ [a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-1) [c](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-2) [d](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-3) [e](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-4) [f](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-5) [g](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-6) [h](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Khalid2022_4-7) Khalid MF, Selvam K, Jeffry AJ, Salmi MF, Najib MA, Norhayati MN, et al. (4 January 2022). ["Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis"](https://doi.org/10.3390%2Fdiagnostics12010110). Diagnostics. 12* (1): 110. [doi](https://en.wikipedia.org/wiki/Doi_$identifier$ "Doi (identifier)"):[10\.3390/diagnostics12010110](https://doi.org/10.3390%2Fdiagnostics12010110). [PMC](https://en.wikipedia.org/wiki/PMC_$identifier$ "PMC (identifier)") [8774565](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774565). [PMID](https://en.wikipedia.org/wiki/PMID_$identifier$ "PMID (identifier)") [35054277](https://pubmed.ncbi.nlm.nih.gov/35054277). 4. ^ [*a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-1) [c](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-2) [d](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-3) [e](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-4) [f](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-5) [g](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Br%C3%BCmmer2022_5-6) Brümmer LE, Katzenschlager S, McGrath S, Schmitz S, Gaeddert M, Erdmann C, et al. (26 May 2022). ["Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors"](https://doi.org/10.1371%2Fjournal.pmed.1004011). PLOS Med. 19* (5) e1004011. [doi](https://en.wikipedia.org/wiki/Doi_$identifier$ "Doi (identifier)"):[10\.1371/journal.pmed.1004011](https://doi.org/10.1371%2Fjournal.pmed.1004011). [PMC](https://en.wikipedia.org/wiki/PMC_$identifier$ "PMC (identifier)") [9187092](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187092). [PMID](https://en.wikipedia.org/wiki/PMID_$identifier$ "PMID (identifier)") [35617375](https://pubmed.ncbi.nlm.nih.gov/35617375). 5. ^ [*a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-1) [c](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-2) [d](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-3) [e](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-4) [f](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-5) [g](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Tapari2022_6-6) Tapari A, Braliou GG, Papaefthimiou M, Mavriki H, Kontou PI, Nikolopoulos GK, et al. (4 June 2022). ["Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis"](https://doi.org/10.3390%2Fdiagnostics12061388). 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[^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Paltiel2021_101-0) Paltiel AD, Zheng A, Sax PE (2021). ["Clinical and Economic Effects of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission"](https://doi.org/10.7326%2FM21-0510). Ann Intern Med. 174 (6): 803–810\. [doi](https://en.wikipedia.org/wiki/Doi_$identifier$ "Doi (identifier)"):[10\.7326/M21-0510](https://doi.org/10.7326%2FM21-0510). [PMC](https://en.wikipedia.org/wiki/PMC_$identifier$ "PMC (identifier)") [9317280](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9317280). [PMID](https://en.wikipedia.org/wiki/PMID_$identifier$ "PMID (identifier)") [33683930](https://pubmed.ncbi.nlm.nih.gov/33683930). 100. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-MarketReportsWorld2022_102-0) ["Global COVID-19 Rapid Antigen Test Kits Market Research Report 2022"](https://www.marketreportsworld.com/global-covid-19-rapid-antigen-test-kits-market-21059402). Market Reports World. 10 June 2022. [Archived](https://web.archive.org/web/20230219234704/https://www.marketreportsworld.com/global-covid-19-rapid-antigen-test-kits-market-21059402) from the original on 19 February 2023. Retrieved 10 July 2022. 101. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Arizton2022_103-0) ["COVID-19 Rapid Antigen Test Kits Market - Global Outlook & Forecast 2022-2027"](https://www.arizton.com/market-reports/covid-19-rapid-antigen-test-kit-market). Arizton Advisory & Intelligence. June 2022. [Archived](https://web.archive.org/web/20220710233516/https://www.arizton.com/market-reports/covid-19-rapid-antigen-test-kit-market) from the original on 10 July 2022. Retrieved 10 July 2022. 102. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-MarketStudyReport2021_104-0) ["Global COVID-19 Antigen Test Market Size study, by Product & Service (Platforms, Reagents & Kits and Services), by End-Use (Clinics & Hospitals, Home Care, Diagnostic Labs and Others) and Regional Forecasts 2021–2027"](https://web.archive.org/web/20220815044715/https://www.marketstudyreport.com/reports/global-covid-19-antigen-test-market-size-research). Market Study Report. 17 July 2021. Archived from [the original](https://www.marketstudyreport.com/reports/global-covid-19-antigen-test-market-size-research) on 15 August 2022. 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Readable Markdown	From Wikipedia, the free encyclopedia \| COVID-19 rapid antigen test \| \| \|---\|---\| \| [![](https://upload.wikimedia.org/wikipedia/commons/thumb/6/6c/Lateral_flow_covid_19_negative_and_positive_test.jpg/250px-Lateral_flow_covid_19_negative_and_positive_test.jpg)](https://en.wikipedia.org/wiki/File:Lateral_flow_covid_19_negative_and_positive_test.jpg)Negative (left, showing Control line) and positive (right, showing Control and Test lines) results \| \| \| [Synonyms](https://en.wikipedia.org/wiki/Synonym "Synonym") \| SARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test[\[a\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-1) \| \| Purpose \| To diagnose [SARS-CoV-2](https://en.wikipedia.org/wiki/SARS-CoV-2 "SARS-CoV-2") infections ([COVID-19](https://en.wikipedia.org/wiki/COVID-19 "COVID-19")) \| \| [LOINC](https://en.wikipedia.org/wiki/LOINC "LOINC") \| [94558-4](https://s.details.loinc.org/LOINC/94558-4.html?sections=Comprehensive), [95209-3](https://s.details.loinc.org/LOINC/95209-3.html?sections=Comprehensive), [96119-3](https://s.details.loinc.org/LOINC/96119-3.html?sections=Comprehensive), [97097-0](https://s.details.loinc.org/LOINC/97097-0.html?sections=Comprehensive) \| COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 [lateral flow tests](https://en.wikipedia.org/wiki/Lateral_flow_test "Lateral flow test") or LFTs, are [rapid antigen tests](https://en.wikipedia.org/wiki/Rapid_antigen_test "Rapid antigen test") used to detect [SARS-CoV-2](https://en.wikipedia.org/wiki/Severe_acute_respiratory_syndrome_coronavirus_2 "Severe acute respiratory syndrome coronavirus 2") infection ([COVID-19](https://en.wikipedia.org/wiki/COVID-19 "COVID-19")). They are quick to implement with minimal training, cost a fraction of other forms of [COVID-19 testing](https://en.wikipedia.org/wiki/COVID-19_testing "COVID-19 testing"), and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.[\[1\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2) Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret\[s\] their test result themselves".[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) [False positives](https://en.wikipedia.org/wiki/False_positive "False positive") are very rare; the tests' [specificity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") is 98%-99%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) However, the tests have a [sensitivity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") of 70%-72%,[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) which is lower than COVID-19 [polymerase chain reaction](https://en.wikipedia.org/wiki/Polymerase_chain_reaction "Polymerase chain reaction") (PCR) tests' sensitivity of 88%-96%.[\[6\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pecoraro2022-7)[\[7\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pu2022-8)[\[b\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-9) Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the [viral load](https://en.wikipedia.org/wiki/Viral_load "Viral load") is higher.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6)[\[8\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Oxford2020-10)[\[9\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Guglielmi2020-11) COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a "confirmed case of SARS-CoV-2 infection" in two ways.[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) First, the person with a positive Antigen-RDT could meet a "probable case definition" such as having recent loss of smell or taste without any known cause, or could meet certain "suspect criteria" such as having a severe acute respiratory illness.[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Second, the person with a positive Antigen-RDT could be asymptomatic but a "contact of a probable or confirmed case."[\[10\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHOCaseDefinition2020-12) Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a "confirmed case."[\[11\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NZ2022-13) Between 2020 and 2021, studies using [mathematical models](https://en.wikipedia.org/wiki/Mathematical_model "Mathematical model") estimated the benefit of frequent RATs in [screening](https://en.wikipedia.org/wiki/Screening_$medicine$ "Screening (medicine)") populations for COVID-19. Paltiel et al studied a hypothetical college campus with 5000 students.[\[12\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) Screening all students every two days with a "low-sensitivity, high-specificity test" (such as a RAT) would be able to control an outbreak of COVID-19.[\[12\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2020-14) [Mina](https://en.wikipedia.org/wiki/Michael_Mina_$epidemiologist$ "Michael Mina (epidemiologist)") et al theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would "capture most infections while they are still infectious."[\[13\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) The quick results of RATs would serve to limit asymptomatic spread.[\[13\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mina2020-15) Larremore et al simulated various COVID-19 population screening strategies.[\[14\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) The researchers found that "effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity."[\[14\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Larremore2021-16) In addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.[\[15\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-17) Furthermore, following the closure of national borders in Europe following the emergence of the [Alpha variant](https://en.wikipedia.org/wiki/Alpha_variant "Alpha variant") just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,[\[16\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-18) effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.[\[17\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-19)[\[18\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-20) [Médecins Sans Frontières](https://en.wikipedia.org/wiki/M%C3%A9decins_Sans_Fronti%C3%A8res "Médecins Sans Frontières") strongly endorsed the use of rapid tests in lower- and middle-income countries, noting "COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level".[\[19\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-21) ### Use for "return to normal" \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=5 "Edit section: Use for \"return to normal\"")\] Spain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,[\[20\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-22) and a free music concert held in [Barcelona](https://en.wikipedia.org/wiki/Barcelona "Barcelona") for individuals who took a rapid test.[\[21\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-23) A similar approach was taken in [Albania](https://en.wikipedia.org/wiki/Albania "Albania") to enable music festivals.[\[22\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-24) However, many experts were unsure of this approach believing that "rapid tests are not the solution to restart normal life"[\[23\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-25) but might be used in conjunction with other infection control techniques.[\[24\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-26) [![](https://upload.wikimedia.org/wikipedia/commons/thumb/9/90/COVID-19_rapid_antigen_test_Certification.jpg/250px-COVID-19_rapid_antigen_test_Certification.jpg)](https://en.wikipedia.org/wiki/File:COVID-19_rapid_antigen_test_Certification.jpg) A certification of quality for a COVID-19 rapid antigen home test. ### False negatives (low sensitivity) \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=7 "Edit section: False negatives (low sensitivity)")\] Although the [specificity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") of RATs are high (98%-99%),[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) in 2020 RATs were criticized for having a [sensitivity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity "Sensitivity and specificity") as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.[\[25\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Service2020-27)[\[26\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Saxena2020-28)[\[27\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Halliday2020-29) As of 2022, [systematic reviews](https://en.wikipedia.org/wiki/Systematic_review "Systematic review") determined that the pooled sensitivities of RATs were 70%-72%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) In one systematic review, the range of sensitivities across studies was 37%-90%.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4) As the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) recommends RATs with "≥ 80% sensitivity",[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) many RATs do not meet the WHO recommendation. In the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) RATs were more sensitive when samples had more viral load, as measured by a low PCR "cycle threshold," and less sensitive when the samples had less viral load.[\[3\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Khalid2022-4)[\[4\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Br%C3%BCmmer2022-5)[\[5\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tapari2022-6) A 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.[\[29\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Chu2022-31) ### Potential for false negative results due to new variants \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=8 "Edit section: Potential for false negative results due to new variants")\] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the [SARS-CoV-2 Alpha variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Alpha_variant "SARS-CoV-2 Alpha variant"). The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours [Public Health England](https://en.wikipedia.org/wiki/Public_Health_England "Public Health England") laboratories were able to confirm that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the [capsid](https://en.wikipedia.org/wiki/Capsid "Capsid") protein and not the [spike protein](https://en.wikipedia.org/wiki/Coronavirus_spike_protein "Coronavirus spike protein").[\[30\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-32) Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.[\[31\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.[\[31\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bourassa2021-33) A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the [Delta variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Delta_variant "SARS-CoV-2 Delta variant") and 69.6%-78.3% for the [Omicron variant](https://en.wikipedia.org/wiki/SARS-CoV-2_Omicron_variant "SARS-CoV-2 Omicron variant") across a range of [viral loads](https://en.wikipedia.org/wiki/Viral_load "Viral load"); however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.[\[32\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bayart2022-34) ### False positive results when instructions not followed \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=9 "Edit section: False positive results when instructions not followed")\] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be [false positive](https://en.wikipedia.org/wiki/False_positives_and_false_negatives#False_positive_error "False positives and false negatives"). Beginning in December 2020, [TikTok](https://en.wikipedia.org/wiki/TikTok "TikTok") videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.[\[33\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Lorch2022-35) Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended [buffer solution](https://en.wikipedia.org/wiki/Buffer_solution "Buffer solution") produced false positives.[\[34\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.[\[34\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Patriquin2021-36) ### Slow deployment and uptake \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=10 "Edit section: Slow deployment and uptake")\] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.[\[35\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Holliday2021-37) ### Toxicity of components \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=11 "Edit section: Toxicity of components")\] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.[\[36\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-38) On 24 February 2022, [Health Canada](https://en.wikipedia.org/wiki/Health_Canada "Health Canada") issued a public advisory warning that there had been a recent increase in calls to poison control centers associated with RATs, which contained the preservatives[\[37\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-39) [sodium azide](https://en.wikipedia.org/wiki/Sodium_azide "Sodium azide") and ProClin.[\[38\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-40) An [antigen](https://en.wikipedia.org/wiki/Antigen "Antigen") is a foreign [molecule](https://en.wikipedia.org/wiki/Molecule "Molecule") or molecular [structure](https://en.wikipedia.org/wiki/Structure "Structure") that can cause an [immune response](https://en.wikipedia.org/wiki/Immune_response "Immune response"). COVID-19 rapid antigen tests (RATs) detect antigenic [proteins](https://en.wikipedia.org/wiki/Protein "Protein") on the surface of or in the interior of the SARS-CoV-2 [coronavirus](https://en.wikipedia.org/wiki/Coronavirus "Coronavirus"). Of the COVID-19 RATs that had received an [emergency use authorization](https://en.wikipedia.org/wiki/Emergency_use_authorization "Emergency use authorization") (EUA) from the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") (FDA) by January 2022, all detected [nucleocapsid](https://en.wikipedia.org/wiki/Nucleocapsid "Nucleocapsid") proteins, and one also detected the receptor-binding domain of the [coronavirus spike protein](https://en.wikipedia.org/wiki/Coronavirus_spike_protein "Coronavirus spike protein").[\[39\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.[\[40\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EUCommonList2020-42) [![](https://upload.wikimedia.org/wikipedia/commons/thumb/d/d3/Lateral_Flow_Assay.jpg/330px-Lateral_Flow_Assay.jpg)](https://en.wikipedia.org/wiki/File:Lateral_Flow_Assay.jpg) Rapid antigen test functioning by [lateral flow assay](https://en.wikipedia.org/wiki/Lateral_flow_assay "Lateral flow assay"). A typical COVID-19 RAT is a [lateral flow test](https://en.wikipedia.org/wiki/Lateral_flow_test "Lateral flow test") (LFT).[\[39\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Drain2022-41): Table S1 [\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) For an LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.[\[42\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\[43\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) The liquid is pulled through the strip by wicking ([capillary action](https://en.wikipedia.org/wiki/Capillary_action "Capillary action")), encountering different chemically-enhanced regions embedded within the strip. First, at a "conjugate pad," soluble antibodies with gold [nanoparticles](https://en.wikipedia.org/wiki/Nanoparticle "Nanoparticle") are picked up by the liquid, attaching to any SARS-CoV-2 antigens present in the sample.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Then, at the test line (which may be labelled "T"), [antibodies](https://en.wikipedia.org/wiki/Antibodies "Antibodies") specific to SARS-CoV-2 are anchored to the strip; these bind to any SARS-CoV-2 antigens, capturing the associated nanoparticles.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) Finally at the control line (which may be labelled "C"), antibodies that can attach to the antibodies with nanoparticles are anchored, capturing the remaining nanoparticles.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43) If there are no SARS-CoV-2 antigens present, then the gold nanoparticles are carried by the liquid, continue through the test line, and then captured at the control line, showing a single indicating a negative test. However, if there are antigens present, then some of the nanoparticles will be stopped at the test line and the rest will be stopped at the control line, showing two lines indicating a positive test.[\[41\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Shirazi2021-43)[\[42\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WelshGovt2022-44)[\[43\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Frew2021-45) ## History of development and deployment \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=13 "Edit section: History of development and deployment")\] [![](https://upload.wikimedia.org/wikipedia/commons/thumb/f/f5/Covid-19_rapid_test_in_Rwanda.jpg/330px-Covid-19_rapid_test_in_Rwanda.jpg)](https://en.wikipedia.org/wiki/File:Covid-19_rapid_test_in_Rwanda.jpg) COVID-19 rapid test being administered in Rwanda In May 2020, the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") (FDA) issued the first [emergency use authorization](https://en.wikipedia.org/wiki/Emergency_use_authorization "Emergency use authorization") (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by [Quidel](https://en.wikipedia.org/wiki/Quidel "Quidel").[\[44\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAQuidel2020-46) In August 2020, the [United States Department of Health and Human Services](https://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services "United States Department of Health and Human Services") announced that the US government would be purchasing 150 million BinaxNOW RATs produced by [Abbott Laboratories](https://en.wikipedia.org/wiki/Abbott_Laboratories "Abbott Laboratories") "to expand strategic, evidence-based testing."[\[45\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-HHS2020-47) Later the agency announced that 100 million of the tests were to be sent to governors to use "at their discretion," for example to reopen schools.[\[46\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Blad2020-48) By September 2020, it was reported that the United Kingdom's [Moonshot program](https://en.wikipedia.org/wiki/Operation_Moonshot "Operation Moonshot") would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.[\[47\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Iacobucci2020-49) In that month, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) released interim guidance on COVID-19 "antigen-detecting rapid diagnostic tests" (Ag-RDTs) including recommendations for their use, selection, and implementation.[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The interim guidance noted that Ag-RDTs were easier to implement and less expensive than [nucleic acid](https://en.wikipedia.org/wiki/Nucleic_acid "Nucleic acid") amplification tests (NAATs).[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) The [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.[\[48\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2020-50) [Health Canada](https://en.wikipedia.org/wiki/Health_Canada "Health Canada") approved its first COVID-19 RAT in October 2020, the Abbott Panbio test.[\[49\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Tasker2020-51) As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.[\[50\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52)[\[51\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Bonislawski2020-53) RATs began to be rolled out across Portuguese schools and care homes.[\[52\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-54) One of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by [Public Health England](https://en.wikipedia.org/wiki/Public_Health_England "Public Health England") and [University of Oxford](https://en.wikipedia.org/wiki/University_of_Oxford "University of Oxford"), with a preliminary report released in November 2020.[\[53\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Oxford2020a-55) The researchers undertook an evaluation of 64 LFDs that proceeded in several phases.[\[54\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) Of the four LFDs with "desirable performance characteristics," one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.[\[54\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Peto2021-56) [![](https://upload.wikimedia.org/wikipedia/commons/thumb/e/e7/NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg/250px-NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg)](https://en.wikipedia.org/wiki/File:NHS_COVID-19_Rapid_Antigen_Test_Kit_2.jpg) Contents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system. On 2 November 2020, [Slovakia](https://en.wikipedia.org/wiki/Slovakia "Slovakia") became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD [Biosensor](https://en.wikipedia.org/wiki/Biosensor "Biosensor") antigen test and performed swabbing on the population.[\[55\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-57)[\[56\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-58) Two research studies on the Slovakia experience were published in early 2021, one by professor [Martin Kahanec](https://en.wikipedia.org/w/index.php?title=Martin_Kahanec&action=edit&redlink=1 "Martin Kahanec (page does not exist)") from [Central European University](https://en.wikipedia.org/wiki/Central_European_University "Central European University") and his coauthors and another one by Martin Pavelka from the [London School of Hygiene & Tropical Medicine](https://en.wikipedia.org/wiki/London_School_of_Hygiene_%26_Tropical_Medicine "London School of Hygiene & Tropical Medicine") and his team. Both studies suggested that rapid antigen mass testing helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.[\[1\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Kahanec2021-2)[\[57\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Pavelka2021-59) The United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November 2020, the [Prime Minister](https://en.wikipedia.org/wiki/Prime_Minister_of_the_United_Kingdom "Prime Minister of the United Kingdom"), [Boris Johnson](https://en.wikipedia.org/wiki/Boris_Johnson "Boris Johnson"), started city-wide screening of [Liverpool](https://en.wikipedia.org/wiki/Liverpool "Liverpool") as part of the accelerated technology evaluation.[\[58\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-60)[\[59\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Littlejohns2020-61) Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at [Durham University](https://en.wikipedia.org/wiki/Durham_University "Durham University"), who had the infrastructure and expertise to manage the rapid test programme,[\[60\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-62) but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[\[61\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-63) Rapid tests were also implemented within the [National Health Service](https://en.wikipedia.org/wiki/National_Health_Service "National Health Service") (NHS) for staff to reduce possible transmission to patients,[\[62\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-64) local authorities [\[63\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-65) and care homes to enable visits to visit residents.[\[64\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-66)[\[65\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-67) On 18 November 2020, [Wales](https://en.wikipedia.org/wiki/Wales "Wales") completed the first whole borough testing at [Merthyr Tydfil](https://en.wikipedia.org/wiki/Merthyr_Tydfil "Merthyr Tydfil").[\[66\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-68)[\[67\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-69) Global efforts to step up evaluations of rapid tests were initiated by the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on 10 November 2020, aided by agreement from the [Bill and Melinda Gates Foundation](https://en.wikipedia.org/wiki/Bill_and_Melinda_Gates_Foundation "Bill and Melinda Gates Foundation") that limited costs for low- and middle-income countries.[\[68\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-70)[\[69\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-71) Austria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[\[70\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-72)[\[71\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-73) By the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[\[72\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-74) the United Kingdom,[\[73\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-75) and the US.[\[74\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-76) These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,[\[75\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-77) travel hubs in Indonesia,[\[76\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-78) and across India.[\[77\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-79) Professor [William A. Haseltine](https://en.wikipedia.org/wiki/William_A._Haseltine "William A. Haseltine") of Harvard said that "rapid, self-administered testing could stem the ever-surging tide of disease and death."[\[78\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-80) However, further deployment of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the \$900 billion in COVID-19 relief contained within the [Consolidated Appropriations Act, 2021](https://en.wikipedia.org/wiki/Consolidated_Appropriations_Act,_2021 "Consolidated Appropriations Act, 2021"). The bill was criticized for not specifically supporting COVID rapid self-tests.[\[79\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-81) Meanwhile, the FDA authorized the Abbott BinaxNOW RAT "for prescription use at home."[\[80\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAAbbott2020-82)[\[81\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Wan2020-83) Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.[\[82\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-84) In the UK in December 2020, the [Medicines and Healthcare products Regulatory Agency](https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency "Medicines and Healthcare products Regulatory Agency") approved the Innova rapid test for self-testing of asymptomatic people.[\[83\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Mahase2020-85) The United Kingdom's chief clinical medic, Dr [Susan Hopkins](https://en.wikipedia.org/wiki/Susan_Hopkins "Susan Hopkins"), noted that rapid tests provided a means to find "people that...we couldn't otherwise find".[\[84\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-86) Noting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the [European Commission](https://en.wikipedia.org/wiki/European_Commission "European Commission") (EC) met in December 2020 and developed a common European framework for "use, validation and mutual recognition of rapid tests", committing 100 million euros for the purchase of tests from [Roche](https://en.wikipedia.org/wiki/Hoffmann-La_Roche "Hoffmann-La Roche") and [Abbott](https://en.wikipedia.org/wiki/Abbott_Laboratories "Abbott Laboratories").[\[85\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EC2020-87) [Stella Kyriakides](https://en.wikipedia.org/wiki/Stella_Kyriakides "Stella Kyriakides"), commissioner for Health and Food Safety, said "Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic."[\[85\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EC2020-87) By January 2021, the [Council of the European Union](https://en.wikipedia.org/wiki/Council_of_the_European_Union "Council of the European Union") advocated greater use of rapid tests, noting that "should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered."[\[86\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-EUCouncil2021-88) In the US, newly inaugurated US president [Joe Biden](https://en.wikipedia.org/wiki/Joe_Biden "Joe Biden") released a national strategy for COVID-19 that pledged to "fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available."[\[87\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Biden2021-89) In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.[\[88\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAOTC2021-90) Innova voluntarily launched a [Class I recall](https://en.wikipedia.org/wiki/FDA_recall_policies#Class_I "FDA recall policies") in the US of more than 77,000 of its RATs in April 2021.[\[89\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) Two months later, the FDA warned Americans to stop using the test because it had "significant concerns that the performance of the test has not been adequately established."[\[89\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAInnova2021-91) A week after the FDA's warning about the Innova test, UK's [Medicines and Healthcare products Regulatory Agency](https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency "Medicines and Healthcare products Regulatory Agency") (MHRA) cleared the rapid diagnostic's use and extended its authorization.[\[90\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Hale2021-92) In October 2021, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) updated its interim guidance on Ag-RDTs.[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.[\[28\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2021-30) Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of "higher-than-acceptable false positive test results for SARS-CoV-2".[\[91\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDAEllume2021-93) In December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.[\[92\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) In response, Dr [Leana Wen](https://en.wikipedia.org/wiki/Leana_Wen "Leana Wen") was quoted as saying that the number of tests "does not come even close to what's needed."[\[92\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2021-94) US president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.[\[93\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-NPR2022-95) In March 2022, the [World Health Organization](https://en.wikipedia.org/wiki/World_Health_Organization "World Health Organization") (WHO) issued interim guidance on self-testing with Ag-RDTs.[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) The WHO made a strong recommendation that COVID-19 Ag-RDT self-testing "should be offered in addition to professionally administered testing services."[\[2\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-WHO2022-3) An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.[\[94\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA2022-96) In October 2024, the US [Food and Drug Administration](https://en.wikipedia.org/wiki/Food_and_Drug_Administration "Food and Drug Administration") granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A\&B Antigen Test.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) Other OTC flu/COVID tests are available under emergency use authorization.[\[95\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-FDA_PR_202401007-97) ### Costs and cost-effectiveness \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=19 "Edit section: Costs and cost-effectiveness")\] In late 2020, it was noted that in the US RATs cost [US\$](https://en.wikipedia.org/wiki/US$ "US$")5-\$23, in contrast with PCR tests which cost at least \$75.[\[50\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Rubin2020-52) In a Danish study published in 2021, RATs cost about \$5.70 per test, as opposed to PCRs at \$10.80 per test.[\[96\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Jakobsen2021-98) A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.[\[97\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Diel2021-99) A 2021 study concluded that if the US is willing to pay \$100,000 per [year of life lost](https://en.wikipedia.org/wiki/Years_of_potential_life_lost "Years of potential life lost") averted, then weekly or monthly testing of the population using RATs is likely to be [cost-effective](https://en.wikipedia.org/wiki/Cost-effectiveness_analysis "Cost-effectiveness analysis").[\[98\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-pmid33549196-100) Another 2021 study estimated [incremental cost-effectiveness ratios](https://en.wikipedia.org/wiki/Incremental_cost-effectiveness_ratio "Incremental cost-effectiveness ratio") of "\$7890 per infection averted and \$1 430 000 per death averted" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.[\[99\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Paltiel2021-101) ### Global market value \[[edit](https://en.wikipedia.org/w/index.php?title=COVID-19_rapid_antigen_test&action=edit&section=20 "Edit section: Global market value")\] Estimates of value of the worldwide market for RATs vary. One estimate was that the market size was \$28 billion in 2021 with a [compound annual growth rate](https://en.wikipedia.org/wiki/Compound_annual_growth_rate "Compound annual growth rate") (CAGR) of -21.7%, leading to a size of \$14 billion in 2028.[\[100\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-MarketReportsWorld2022-102) A second estimate suggested that the market value was \$4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of \$743 million in 2027.[\[101\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-Arizton2022-103) A third estimate found a value of \$5.3 billion in 2020, which was "anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027."[\[102\]](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_note-MarketStudyReport2021-104) 1. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-1) "Point of care test" and "rapid test" could refer to "rapid antigen test" but could also refer to tests that use PCR or other technologies. 2. [^](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-9) The study by Pecoraro et al found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88. 1. ^ [*a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-Kahanec2021_2-1) 2. ^ [a](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-0) [b](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-1) [c](https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test#cite_ref-WHO2022_3-2) Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Interim guidance (Report). 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