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URLhttps://www.cidrap.umn.edu/high-false-negative-rate-limits-value-rapid-covid-tests-kids
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Meta TitleHigh false-negative rate limits value of rapid COVID tests for kids | CIDRAP
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A meta-analysis published this week in BMJ shows that COVID-19 rapid antigen tests for children don't meet minimum performance standards set by the World Health Organization (WHO) and the US Food and Drug Administration (FDA). Already shown to be far less sensitive in adults than their manufacturers report, rapid antigen tests, also called lateral flow tests, are widely used in children to screen for COVID-19 in schools, homes, and healthcare settings. Amid scarcity of the over-the-counter tests, US households can now order four such tests from a US government website for free. While experts say these nasal-swab tests—sold under brand names such as BinaxNOW and BD Veritor—have some value in disrupting virus transmission, it's important to understand their limitations—especially amid the current surge of cases caused by the highly transmissible and evasive Omicron (B.1.1.529) variant. "I think an important point to remember is that with rapid antigen tests, positive results are generally meaningful, but negative results have to be taken with a grain of salt," Kelly Wroblewski, MPH, director of infectious diseases at the Association of Public Health Laboratories, told CIDRAP News. Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News, calls interpreting negative test results "a huge challenge." "The average consumer isn't going to know what this means. Many people will get a negative result and go to dinner with Grandma and Grandpa." Poor sensitivity, acceptable specificity In the first meta-analysis of its kind, a team led by University of Manchester researchers in the United Kingdom evaluated 17 studies involving 6,355 children that compared rapid antigen test results with those from the gold-standard: reverse transcription polymerase chain reaction (RT-PCR) test. The studies assessed eight tests from six different brands. Overall pooled diagnostic sensitivity and specificity of the rapid tests were 64.2% and 99.1%, respectively. In children with symptoms, diagnostic sensitivity and specificity were 71.8% and 98.7%, respectively, and in those without symptoms, sensitivity and specificity were 56.2% and 98.6%, respectively. For reference, WHO and FDA performance standards for rapid antigen tests specify a minimum sensitivity of 80% and a minimum specificity of 97%. Sensitivity is the probability that a test correctly identifies all positive cases; the higher the sensitivity, the lower the likelihood of false-negative results. Specificity, on the other hand, is the ability to identify those who don't have a condition; the higher the specificity, the lower the risk of false-positive results. Of the 12 peer-reviewed studies in journals and 5 published on preprint servers, only 1 was at low risk of bias. The researchers concluded that the real-world performance of rapid antigen tests in children varied widely, only a few tests had relevant data, and the risk of bias was unclear due to poor reporting. "Evidence gaps identified in this systematic review demonstrate current research needs to support evidence-based decision making," they wrote. "In particular, evidence is needed on the real-life performance of tests in schools (self-testing performed by children) and kindergarten (sample collection in toddlers by laypersons). … Moreover, the implementation of routine audits of testing programmes may allow monitoring of test performance in practice outside of studies." Many questions remain Rapid antigen tests for COVID-19 first became available in May 2020, when the FDA issued emergency use authorization for Quidel Corporation's Sofia 2 SARS Antigen FIA. Since then, dozens of such tests have come to market. They are convenient and can generate results in as fast as 15 minutes. By comparison—and depending on demand and availability—several days may pass before more accurate PCR results are available. On Dec 28, 2021, the FDA reported on its website that preliminary research on the performance of rapid antigen tests in patients infected with Omicron suggests that "antigen tests do detect the omicron variant but may have reduced sensitivity," referring to the potential for false-negative results. The FDA should have released clearer information sooner, Osterholm said, citing cases whereby "an individual is negative for multiple days in a lateral flow test, including on the day a PCR test shows that they are, in fact, positive. We're still trying to clarify what the results tells us about one's infection status and whether it tells us anything about how infectious you are and able to transmit the virus." Tests don't eliminate risks The uncertainty about whether negative rapid antigen tests can be trusted—as well as the similarity of COVID-19 symptoms and those caused by allergies or other common infectious diseases—has caused confusion for parents trying to make decisions about school and other activities. Wroblewski recommends that parents of symptomatic children who receive a negative result from a rapid antigen test seek a PCR test for confirmation. If a child tests negative on a rapid test and has no symptoms but was exposed to COVID-19 at school or elsewhere, following up with another rapid test a day or two later could be prudent, she said. "I think parents can, to a certain extent, use their judgment," with negative test results, Wroblewski said. "If your kid has the sniffles but no severe symptoms, no fever, you can probably send them to school with a mask. But if they've had an exposure and have a sniffle, maybe just keep them home. Even if it's not COVID, they could have something else that's infectious." However, if children test positive and have symptoms, they should be considered infected and kept home from school and other activities, Osterholm said. The important thing to understand is that rapid tests are not perfect, Wroblewski said. "If your child is asymptomatic and you're using rapid antigen tests to identify those asymptomatic infections before they go to school, see grandparents, or get on a plane, you're not going to eliminate the risk that someone is actually infected and might move to positive in the next 24 hours," she said. "You're mitigating the risk."
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Topics & Projects - - [Antimicrobial Stewardship](https://www.cidrap.umn.edu/antimicrobial-stewardship/superbugs-you) - [Chronic Wasting Disease](https://www.cidrap.umn.edu/chronic-wasting-disease/cwd-pod) - [Osterholm Update](https://www.cidrap.umn.edu/osterholm-update) Podcasts - [Newsletters](https://www.cidrap.umn.edu/newsletter) - - [About CIDRAP](https://www.cidrap.umn.edu/about-cidrap) - [CIDRAP in the News](https://www.cidrap.umn.edu/cidrap-news) - [Our Staff](https://www.cidrap.umn.edu/about-us/cidrap-staff) - [Our Director](https://www.cidrap.umn.edu/michael-t-osterholdm-phd-mph) - [Osterholm in the Press](https://www.cidrap.umn.edu/osterholm-quotes) - [Shop Merchandise](https://www.mnalumnimarket.com/collections/cidrap?utm_source=website&utm_medium=website&utm_campaign=CIDRAPdonate&utm_content=CIDRAP "(opens in a new window)") - [Contact Us](https://www.cidrap.umn.edu/contact-us) About Search - [Support](https://www.cidrap.umn.edu/support) [Menu](https://www.cidrap.umn.edu/high-false-negative-rate-limits-value-rapid-covid-tests-kids#off-canvas "Menu") # High false-negative rate limits value of rapid COVID tests for kids Mary Van Beusekom \| News Writer \| CIDRAP News January 21, 2022 [COVID-19](https://www.cidrap.umn.edu/covid-19) ![Mother swabbing child for rapid COVID-19 test](https://www.cidrap.umn.edu/sites/default/files/styles/article_detail/public/images/news/mother_swabbing_child_rapid_test.jpg?itok=emkySwjS) ![Mother swabbing child for rapid COVID-19 test](https://www.cidrap.umn.edu/sites/default/files/styles/thumbnail/public/media/article/mother_swabbing_child_rapid_test.jpg?itok=5wLskG1v) > tatyana\_tomsickova / iStock Share A [meta-analysis](https://ebm.bmj.com/content/early/2022/01/04/bmjebm-2021-111828 "(opens in a new window)") published this week in *BMJ* shows that COVID-19 rapid antigen tests for children don't meet minimum performance standards set by the World Health Organization (WHO) and the US Food and Drug Administration (FDA). Already shown to be far less sensitive in adults than their manufacturers report, rapid antigen tests, also called lateral flow tests, are widely used in children to screen for COVID-19 in schools, homes, and healthcare settings. Amid scarcity of the over-the-counter tests, US households can now order four such tests from a US government [website](https://www.covidtests.gov/ "(opens in a new window)") for free. While experts say these nasal-swab tests—sold under brand names such as BinaxNOW and BD Veritor—have some value in disrupting virus transmission, it's important to understand their limitations—especially amid the current surge of cases caused by the highly transmissible and evasive Omicron (B.1.1.529) variant. "I think an important point to remember is that with rapid antigen tests, positive results are generally meaningful, but negative results have to be taken with a grain of salt," Kelly Wroblewski, MPH, director of infectious diseases at the Association of Public Health Laboratories, told CIDRAP News. Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News, calls interpreting negative test results "a huge challenge." "The average consumer isn't going to know what this means. Many people will get a negative result and go to dinner with Grandma and Grandpa." ### Poor sensitivity, acceptable specificity In the first meta-analysis of its kind, a team led by University of Manchester researchers in the United Kingdom evaluated 17 studies involving 6,355 children that compared rapid antigen test results with those from the gold-standard: reverse transcription polymerase chain reaction (RT-PCR) test. The studies assessed eight tests from six different brands. Overall pooled diagnostic sensitivity and specificity of the rapid tests were 64.2% and 99.1%, respectively. In children with symptoms, diagnostic sensitivity and specificity were 71.8% and 98.7%, respectively, and in those without symptoms, sensitivity and specificity were 56.2% and 98.6%, respectively. For reference, WHO and FDA performance standards for rapid antigen tests specify a minimum sensitivity of 80% and a minimum specificity of 97%. Sensitivity is the probability that a test correctly identifies all positive cases; the higher the sensitivity, the lower the likelihood of false-negative results. Specificity, on the other hand, is the ability to identify those who don't have a condition; the higher the specificity, the lower the risk of false-positive results. Of the 12 peer-reviewed studies in journals and 5 published on preprint servers, only 1 was at low risk of bias. The researchers concluded that the real-world performance of rapid antigen tests in children varied widely, only a few tests had relevant data, and the risk of bias was unclear due to poor reporting. "Evidence gaps identified in this systematic review demonstrate current research needs to support evidence-based decision making," they wrote. "In particular, evidence is needed on the real-life performance of tests in schools (self-testing performed by children) and kindergarten (sample collection in toddlers by laypersons). … Moreover, the implementation of routine audits of testing programmes may allow monitoring of test performance in practice outside of studies." ### Many questions remain Rapid antigen tests for COVID-19 first became available in May 2020, when the FDA issued emergency use authorization for Quidel Corporation's Sofia 2 SARS Antigen FIA. Since then, dozens of such tests have come to market. They are convenient and can generate results in as fast as 15 minutes. By comparison—and depending on demand and availability—several days may pass before more accurate PCR results are available. On Dec 28, 2021, the FDA reported on its [website](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests#omicronvariantimpact "(opens in a new window)") that preliminary research on the performance of rapid antigen tests in patients infected with Omicron suggests that "antigen tests do detect the omicron variant but may have reduced sensitivity," referring to the potential for false-negative results. The FDA should have released clearer information sooner, Osterholm said, citing cases whereby "an individual is negative for multiple days in a lateral flow test, including on the day a PCR test shows that they are, in fact, positive. We're still trying to clarify what the results tells us about one's infection status and whether it tells us anything about how infectious you are and able to transmit the virus." ### Tests don't eliminate risks The uncertainty about whether negative rapid antigen tests can be trusted—as well as the similarity of COVID-19 symptoms and those caused by allergies or other common infectious diseases—has caused confusion for parents trying to make decisions about school and other activities. Wroblewski recommends that parents of symptomatic children who receive a negative result from a rapid antigen test seek a PCR test for confirmation. If a child tests negative on a rapid test and has no symptoms but was exposed to COVID-19 at school or elsewhere, following up with another rapid test a day or two later could be prudent, she said. "I think parents can, to a certain extent, use their judgment," with negative test results, Wroblewski said. "If your kid has the sniffles but no severe symptoms, no fever, you can probably send them to school with a mask. But if they've had an exposure and have a sniffle, maybe just keep them home. Even if it's not COVID, they could have something else that's infectious." However, if children test positive and have symptoms, they should be considered infected and kept home from school and other activities, Osterholm said. The important thing to understand is that rapid tests are not perfect, Wroblewski said. "If your child is asymptomatic and you're using rapid antigen tests to identify those asymptomatic infections before they go to school, see grandparents, or get on a plane, you're not going to eliminate the risk that someone is actually infected and might move to positive in the next 24 hours," she said. "You're mitigating the risk." ## Related news Previous Next [Long COVID takes \$1 trillion global economic toll each year, analysis suggests November 24, 2025 Laine Bergeson ![woman at computer](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/longcovidbrainfog.jpg?itok=V3nVFwft)](https://www.cidrap.umn.edu/covid-19/long-covid-takes-1-trillion-global-economic-toll-each-year-analysis-suggests) [Surveys find strong confidence in childhood vaccines but deepening partisan divides; most adults reject COVID shot November 19, 2025 Laine Bergeson ![baby at doctor's office](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/baby_boy_docs_office.jpg?itok=fhmjby3V)](https://www.cidrap.umn.edu/covid-19/surveys-find-strong-confidence-childhood-vaccines-deepening-partisan-divides-most-adults) [Data: Risks of vascular, inflammatory conditions in kids higher after COVID infection than vaccination November 5, 2025 Mary Van Beusekom ![Young child in hospital bed](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/Young%20child%20in%20hospital%20bed.png?itok=OtEWzJcU)](https://www.cidrap.umn.edu/covid-19/data-risks-vascular-inflammatory-conditions-kids-higher-after-covid-infection-vaccination) [Fewer people are being vaccinated against respiratory diseases December 5, 2025 Liz Szabo ![Young woman and vaccine tray](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/Young%20woman%20vaccination%20tray-AAP.jpg?itok=yi7OgXb6)](https://www.cidrap.umn.edu/adult-non-flu-vaccines/fewer-people-are-being-vaccinated-against-respiratory-diseases) [US measles outbreak tops 1,800 cases as respiratory illness surveillance returns December 3, 2025 Stephanie Soucheray ![sick child](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/iStock-2225348450.jpg?itok=36CL3nVG)](https://www.cidrap.umn.edu/measles/us-measles-outbreak-tops-1800-cases-respiratory-illness-surveillance-returns) [FDA official proposes ā€˜impossible’ standards for vaccine testing that could curtail access to immunizations December 1, 2025 Liz Szabo ![Boy getting vaccinated](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/Boy%20getting%20vaccinated.jpg?itok=kmtRh26G)](https://www.cidrap.umn.edu/childhood-vaccines/fda-official-proposes-impossible-standards-vaccine-testing-could-curtail-access) [COVID patients have higher rates of depression, anxiety, headache, and fatigue before diagnosis, study suggests November 26, 2025 Laine Bergeson ![woman on couch with headache](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/woman_on_couch_with_headache_0.jpg?itok=-ghhI6Dl)](https://www.cidrap.umn.edu/covid-19/covid-patients-have-higher-rates-depression-anxiety-headache-and-fatigue-diagnosis-study) [Study maps 8 long-COVID symptom patterns in adults November 25, 2025 Laine Bergeson ![woman with headache](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/woman%20with%20headache.jpg?itok=qWdGhaB1)](https://www.cidrap.umn.edu/covid-19/study-maps-8-long-covid-symptom-patterns-adults) [Long COVID takes \$1 trillion global economic toll each year, analysis suggests November 24, 2025 Laine Bergeson ![woman at computer](https://www.cidrap.umn.edu/sites/default/files/styles/hand_curated_related_teaser/public/article/longcovidbrainfog.jpg?itok=V3nVFwft)](https://www.cidrap.umn.edu/covid-19/long-covid-takes-1-trillion-global-economic-toll-each-year-analysis-suggests) [Surveys find strong confidence in childhood vaccines but deepening partisan divides; 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[FDA official proposes ā€˜impossible’ standards for vaccine testing that could curtail access to immunizations Vinay Prasad claimed—but provided no evidence—that COVID-19 vaccines caused the death of 10 children. Liz Szabo December 1, 2025 ![Boy getting vaccinated](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/Boy%20getting%20vaccinated.jpg?itok=hAnPj74r)](https://www.cidrap.umn.edu/childhood-vaccines/fda-official-proposes-impossible-standards-vaccine-testing-could-curtail-access) 2. [Death toll climbs in Ethiopia's Marburg outbreak Three new deaths have been confirmed in the outbreak, bringing the death toll to 8. Chris Dall December 1, 2025](https://www.cidrap.umn.edu/marburg/death-toll-climbs-ethiopias-marburg-outbreak) 3. [Vaccinating newborns against hepatitis B saves lives. Why might a CDC panel stop recommending it? The universal HBV birth dose has prevented an estimated 90,100 childhood deaths since 1991, but a federal vaccine advisory group may vote to end the practice. Liz Szabo December 3, 2025 ![Doctor vaccinating newborn](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/iStock-1147681995.jpg?itok=A-i6Imq5)](https://www.cidrap.umn.edu/childhood-vaccines/vaccinating-newborns-against-hepatitis-b-saves-lives-why-might-cdc-panel-stop) 4. [During chaotic meeting, CDC advisers handpicked by RFK Jr. postpone vote on changing hepatitis B vaccine recommendations Although the hepatitis B vaccine is widely heralded as a public health success story, Kennedy has long targeted the vaccine as unnecessary and dangerous. Liz Szabo Mary Van Beusekom Chris Dall December 4, 2025 ![CDC sign](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/CDC%20sign-CDC.jpg?itok=_srO6ONI)](https://www.cidrap.umn.edu/childhood-vaccines/during-chaotic-meeting-cdc-advisers-handpicked-rfk-jr-postpone-vote-changing) 5. [New review finds no evidence to support delaying universal hepatitis B birth-dose vaccination Analysis of more than 400 studies reveals no evidence that delaying the universal hepatitis B vaccine birth dose improves safety or effectiveness. Laine Bergeson December 2, 2025 ![Mom in hospital with newborn](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/Mom%20in%20hospital%20with%20newborn.jpg?itok=fgXbEXTP)](https://www.cidrap.umn.edu/childhood-vaccines/new-review-finds-no-evidence-support-delaying-universal-hepatitis-b-birth-dose) 6. [US flu activity on the rise Only 1 state—Louisiana—reported high influenza-like illness. Stephanie Soucheray December 2, 2025](https://www.cidrap.umn.edu/influenza-general/us-flu-activity-rise) 7. [US measles outbreak tops 1,800 cases as respiratory illness surveillance returns Current US hot spots are Utah, Arizona, and South Carolina. Stephanie Soucheray December 3, 2025 ![sick child](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/iStock-2225348450.jpg?itok=UoyvqIdy)](https://www.cidrap.umn.edu/measles/us-measles-outbreak-tops-1800-cases-respiratory-illness-surveillance-returns) 8. [Days ahead of ACIP meeting, chair moves to senior HHS position Martin Kulldorff, PhD, has been appointed chief science officer for the Office of the Assistant Secretary for Planning and Evaluation. Chris Dall December 2, 2025 ![Martin Kulldorff](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/512px-Martin_Kulldorff.jpg?itok=NUKoSTG8)](https://www.cidrap.umn.edu/childhood-vaccines/days-ahead-acip-meeting-chair-moves-senior-hhs-position) 9. [CDC advisers drop decades-old universal hepatitis B birth dose recommendation, suggest blood testing after 1 dose The measures, which passed despite vehement protests from several members, drew swift rebuke from the medical community. Mary Van Beusekom Laine Bergeson Liz Szabo Chris Dall December 5, 2025 ![CDC headquarters from outside](https://www.cidrap.umn.edu/sites/default/files/styles/article_teaser/public/article/cdc_headquarters-cdc.jpg?itok=8TfkBufM)](https://www.cidrap.umn.edu/anti-science/cdc-advisers-drop-decades-old-universal-hepatitis-b-birth-dose-recommendation-suggest) 10. 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