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For Health Care Providers
This overview describes current information on the types of tests used to detect SARS-CoV-2 infection and their intended uses. This information is intended for use by healthcare providers, public health professionals, and those organizing and implementing testing in non-healthcare settings.
Test types
Resource
Information for the general public on COVID-19 testing is also
available
.
Viral tests
, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to
detect current infection
with SARS-CoV-2, determine the need for prevention measures, and inform a person's medical care.
Viral tests
Nucleic acid amplification tests (NAATs) are highly sensitive and highly specific tests that detect one or more viral ribonucleic acid (RNA) genes. PCR tests are the most common type of NAAT used for COVID-19 testing. Viral RNA may stay in a person's body for up to 90 days after they test positive. Therefore, NAATs should not be used to test someone who has tested positive in the last 90 days. Most NAATs need to be performed in a laboratory, although some are performed at the point-of-care. Most NAATs produce qualitative (positive/negative) results.
Antigen tests are immunoassays that detect the presence of specific viral proteins, called antigens. A positive test indicates current infection. Antigen tests generally have high specificity, similar to NAATs, but are less sensitive than most NAATs. Because antigen tests have lower sensitivity,
FDA recommends
that negative antigen tests be repeated up to three times, with each test 48 hours apart to confirm a negative result. Most antigen tests are less expensive than NAATs and can provide results in minutes. Antigen tests are available for at-home testing (self-testing), at the point of care, or in a laboratory.
As noted in the labeling for authorized over-the-counter antigen tests: Negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see
FDA guidance
on the use of at-home COVID-19 antigen tests.
Other diagnostic tests may be used to detect SARS-CoV-2 from non-traditional respiratory specimens, such as breath. These tests' results may be presumptive and require confirmation by NAAT. Please refer to
each test's Instructions for Use (IFU
) for specific interpretation.
Positive viral test results
indicate current infection and the person with COVID-19 should take steps to
prevent spreading
COVID-19 to others.
Negative viral test results
mean the test did not detect the virus, but this doesn't rule out that the person could have an infection. These results represent a snapshot of the time around specimen collection and could change if the same test was performed again in one or more days. Negative antigen test results should be repeated following
FDA guidance
.
Antibody (or serology) tests
are used to
test for the presence of antibodies
from previous infection or vaccination and can aid in fulfilling the case definition for
multisystem inflammatory syndrome in children (MIS-C)
and
adults (MIS-A)
.
1
Antibody testing does not diagnose current infection. Antibody testing is primarily used for public health surveillance and epidemiologic purposes. Antibody tests detect specific antibodies that target different parts (nucleocapsid or spike protein) of the virus. Detection of anti-nucleocapsid antibody indicates SARS-CoV-2 infection, while anti-spike protein antibody may be induced by COVID-19 vaccination or by SARS-CoV-2 infection. This should be considered when choosing whether to test for antibodies originating from past infection versus those from vaccination.
COVID-19 Test Monitoring
FDA continually monitors the accuracy of COVID-19 tests. Their
website
provides up-to-date information on the impact of viral mutations on COVID-19 tests. See FDA's list of
In Vitro Diagnostics Emergency Use Authorizations
for more information about the performance and interpretation of specific authorized tests.
Diagnostic testing
T
esting individuals with signs or symptoms consistent with COVID-19
Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT.
Additionally, consider other illnesses with similar symptoms that may require testing. For many diseases, including flu, early diagnosis and prompt treatment can be important for preventing severe illness.
Anyone who tests positive should take steps to
prevent spreading
COVID-19 to others or, if in a healthcare setting, be placed on
appropriate precautions
. Some people should receive
treatment
. Most people with COVID-19 have mild illness and can recover at home.
Vaccination and SARS-CoV-2 testing
Vaccination does not affect the results of someone's SARS-CoV-2 NAAT, antigen, or other diagnostic tests.
The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA
COVID-19 vaccines
use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination.
Antibody testing is not currently recommended to assess a person's protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person. Antibody testing can be used in the diagnosis of
Multisystem Inflammatory Syndrome in Children (MIS-C)
or
Multisystem Inflammatory Syndrome in Adults (MIS-A)
.
To evaluate for evidence of previous infection in a vaccinated individual, use an antibody test specifically evaluating IgM/IgG to the nucleocapsid protein. For example, specific antibody tests can be used for public health surveillance.
Table 1. NAAT and Antigen Test* Differences
NAATs
Antigen Tests*
Intended Use
Diagnose
current
infection
Diagnose
current
infection
Analyte Detected
Viral ribonucleic acid (RNA)
Viral antigens
Specimen Type(s)
Nasal, nasopharyngeal, oropharyngeal, sputum, saliva
Nasal, nasopharyngeal
Sensitivity
Varies by test, but generally high for laboratory-based tests and moderate-to-high for point-of-care (POC) tests
Less sensitive than NAATs. Varies by test and depending on the course of infection+*
Specificity
High
High
Test Complexity
Varies by test
Relatively easy to use
Authorized for Use at the Point of Care
Most are not, some are
Most are, some are not
Turnaround Time
Most 1ā3 days; some are rapid with results in 15 minutes
Ranges from 15 minutes to 30 minutes
Cost/Test
~$75-$100/test
~$5-$50/test
Advantages
Most sensitive test method available
Short turnaround time for NAAT POC tests, but few available
Usually does not need to be repeated to confirm results
Short turnaround time (approximately 15 minutes) ā
Cost-effective
Some can be performed at home, or anywhere else
Disadvantages
Longer turnaround time for lab-based tests (1ā3 days)
Higher cost per test
After an infection has ended, and the risk of transmission has passed, people may have detectable RNA and test positive for up to 90 days
Negative tests should be confirmed by NAAT or repeated as
recommended by FDA
Less sensitive (more false negative results) compared to NAATs, especially among asymptomatic people and with some variants
Notice
* As noted in the labeling for authorized over-the-counter antigen tests: negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see
FDA guidance
āÆon the use of at-home COVID-19 antigen tests.
ā The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently.
ā Refers to point-of-care antigen tests only.
Health Equity in SARS-CoV-2 testing
Social determinants of health may influence access to testing. For example, travel time may limit access to, and use of, testing services for those who have limited access to transportation and who live in areas with fewer public transit services and schedules. Racial and ethnic disparities in test site distribution have been found
2
. Other factors that may affect both access to, and use of, testing services include:
Lack of health insurance
Concern about the costs or co-pays
Occupational factors such as not being able to take time off work and lack of paid leave
Lack of accessible options for people with disabilities, and
Distrust of the government and healthcare systems
3,4,5,6
Delays in testing may also delay seeking care and treatment (when sick) as well as delays in prevention measures that could reduce the spread of the virus to others.
One component to move toward greater health equity is ensuring availability of resources, including access to testing for populations who have experienced longstanding, systemic health and social inequities. All population groups, including racial and ethnic minority groups, should have equal access to affordable, quality, and timely SARS-CoV-2 testingāwith fast turnaround time for results. Efforts should be made to address barriers that might overtly or inadvertently create inequalities in testing.
In addition, completeness of race and ethnicity data is an important factor in understanding the impact the virus has on racial and ethnic minority populations. When possible, healthcare providers and public health professionals should ask and record race and ethnicity for anyone receiving a reportable test result and ensure these data are reported with the personās test results to facilitate understanding the impact of COVID-19 on racial and ethnic minority populations.
Some strategies to achieve health equity in testing access and availability include:
Use a
social vulnerability index
to assist in selecting testing sites.
Increase the availability of free testing sites in communities. Employers, community-based, and faith-based organizations can be important partners to increase the number of free, community-based testing sites. This expansion ensures that wait times both for testing and reporting of results are decreased.
Increase accessible and culturally appropriate public messaging about the importance of testing and communicate these messages in multiple accessible formats, languages, and venues, particularly in communities at higher risk and disproportionately impacted by the virus.
References
Morris SB, Schwartz NG, Patel P, et al.
Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection ā United Kingdom and United States, March-August 2020
.
MMWR
Morb Mortal Wkly Rep
. 2020;69(40):1450-1456. Published 2020 Oct 9. doi:10.15585/mmwr.mm6940e1
Dalva-Baird NP, Alobuia WM, Bendavid E, Bhattacharya J.
Racial and ethnic inequities in the early distribution of U.S. COVID-19 testing sites and mortality
.
Eur J Clin Invest
. 2021;51(11):e13669. doi:10.1111/eci.13669
Economic Policy Institute.
Black Workers Face Two of the Most Lethal Preexisting Conditions for CoronavirusāRacism and Economic Inequality
[online]. 2020 [cited 2020 Jun 28].
Berchick, Edward R., Jessica C. Barnett, and Rachel D. Upton Current Population Reports, P60-267(RV),
Health Insurance Coverage in the United States: 2018
,
Government Printing Office, Washington, DC, 2019.
Institute of Medicine (US) Committee on the Consequences of Uninsurance.
Care Without Coverage: Too Little, Too Late
.
Washington (DC): National Academies Press (US); 2002.
Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Smedley BD, Stith AY, Nelson AR, eds.
Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care
. Washington (DC): National Academies Press (US); 2003.
August 29, 2024 |
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For Health Care Providers
# Overview of Testing for SARS-CoV-2
## What to know
This overview describes current information on the types of tests used to detect SARS-CoV-2 infection and their intended uses. This information is intended for use by healthcare providers, public health professionals, and those organizing and implementing testing in non-healthcare settings.
## Test types
### Resource
Information for the general public on COVID-19 testing is also [available](https://www.cdc.gov/covid/testing/index.html).
**Viral tests**, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to **detect current infection** with SARS-CoV-2, determine the need for prevention measures, and inform a person's medical care.
### Viral tests
- Nucleic acid amplification tests (NAATs) are highly sensitive and highly specific tests that detect one or more viral ribonucleic acid (RNA) genes. PCR tests are the most common type of NAAT used for COVID-19 testing. Viral RNA may stay in a person's body for up to 90 days after they test positive. Therefore, NAATs should not be used to test someone who has tested positive in the last 90 days. Most NAATs need to be performed in a laboratory, although some are performed at the point-of-care. Most NAATs produce qualitative (positive/negative) results.
- Antigen tests are immunoassays that detect the presence of specific viral proteins, called antigens. A positive test indicates current infection. Antigen tests generally have high specificity, similar to NAATs, but are less sensitive than most NAATs. Because antigen tests have lower sensitivity, [FDA recommends](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions#negative) that negative antigen tests be repeated up to three times, with each test 48 hours apart to confirm a negative result. Most antigen tests are less expensive than NAATs and can provide results in minutes. Antigen tests are available for at-home testing (self-testing), at the point of care, or in a laboratory.
- As noted in the labeling for authorized over-the-counter antigen tests: Negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see [FDA guidance](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions#negative) on the use of at-home COVID-19 antigen tests.
- Other diagnostic tests may be used to detect SARS-CoV-2 from non-traditional respiratory specimens, such as breath. These tests' results may be presumptive and require confirmation by NAAT. Please refer to [each test's Instructions for Use (IFU](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-other-tests-sars-cov-2)) for specific interpretation.
**Positive viral test results** indicate current infection and the person with COVID-19 should take steps to [prevent spreading](https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html) COVID-19 to others.
**Negative viral test results** mean the test did not detect the virus, but this doesn't rule out that the person could have an infection. These results represent a snapshot of the time around specimen collection and could change if the same test was performed again in one or more days. Negative antigen test results should be repeated following [FDA guidance](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety).
**Antibody (or serology) tests** are used to **test for the presence of antibodies** from previous infection or vaccination and can aid in fulfilling the case definition for [multisystem inflammatory syndrome in children (MIS-C)](https://www.cdc.gov/mis/hcp/clinical-overview/index.html) and [adults (MIS-A)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html#cdc_generic_section_2-mis-a-case-definition).1 Antibody testing does not diagnose current infection. Antibody testing is primarily used for public health surveillance and epidemiologic purposes. Antibody tests detect specific antibodies that target different parts (nucleocapsid or spike protein) of the virus. Detection of anti-nucleocapsid antibody indicates SARS-CoV-2 infection, while anti-spike protein antibody may be induced by COVID-19 vaccination or by SARS-CoV-2 infection. This should be considered when choosing whether to test for antibodies originating from past infection versus those from vaccination.
### COVID-19 Test Monitoring
FDA continually monitors the accuracy of COVID-19 tests. Their [website](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests) provides up-to-date information on the impact of viral mutations on COVID-19 tests. See FDA's list of [In Vitro Diagnostics Emergency Use Authorizations](https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas) for more information about the performance and interpretation of specific authorized tests.
## Diagnostic testing
***T**esting individuals with signs or symptoms consistent with COVID-19***
Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT.
Additionally, consider other illnesses with similar symptoms that may require testing. For many diseases, including flu, early diagnosis and prompt treatment can be important for preventing severe illness.
Anyone who tests positive should take steps to [prevent spreading](https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html) COVID-19 to others or, if in a healthcare setting, be placed on [appropriate precautions](https://www.cdc.gov/covid/hcp/infection-control/index.html). Some people should receive [treatment](https://www.cdc.gov/covid/treatment/index.html). Most people with COVID-19 have mild illness and can recover at home.
## Vaccination and SARS-CoV-2 testing
Vaccination does not affect the results of someone's SARS-CoV-2 NAAT, antigen, or other diagnostic tests.
The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA [COVID-19 vaccines](https://www.cdc.gov/covid/vaccines/stay-up-to-date.html#cdc_vaccine_recommendations_reason_benefit-how-well-covid-19-vaccines-work) use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination.
Antibody testing is not currently recommended to assess a person's protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person. Antibody testing can be used in the diagnosis of [Multisystem Inflammatory Syndrome in Children (MIS-C)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html) or [Multisystem Inflammatory Syndrome in Adults (MIS-A)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html#cdc_generic_section_2-mis-a-case-definition).
To evaluate for evidence of previous infection in a vaccinated individual, use an antibody test specifically evaluating IgM/IgG to the nucleocapsid protein. For example, specific antibody tests can be used for public health surveillance.
### Table 1. NAAT and Antigen Test\* Differences
| | NAATs | Antigen Tests\* |
|---|---|---|
| **Intended Use** | Diagnose *current* infection | Diagnose *current* infection |
| **Analyte Detected** | Viral ribonucleic acid (RNA) | Viral antigens |
| **Specimen Type(s)** | Nasal, nasopharyngeal, oropharyngeal, sputum, saliva | Nasal, nasopharyngeal |
| **Sensitivity** | Varies by test, but generally high for laboratory-based tests and moderate-to-high for point-of-care (POC) tests | Less sensitive than NAATs. Varies by test and depending on the course of infection+\* |
| **Specificity** | High | High |
| **Test Complexity** | Varies by test | Relatively easy to use |
| **Authorized for Use at the Point of Care** | Most are not, some are | Most are, some are not |
| **Turnaround Time** | Most 1ā3 days; some are rapid with results in 15 minutes | Ranges from 15 minutes to 30 minutes |
| **Cost/Test** | ~\$75-\$100/test | ~\$5-\$50/test |
| **Advantages** | Most sensitive test method available Short turnaround time for NAAT POC tests, but few available Usually does not need to be repeated to confirm results | Short turnaround time (approximately 15 minutes) ā Cost-effective Some can be performed at home, or anywhere else |
| **Disadvantages** | Longer turnaround time for lab-based tests (1ā3 days) Higher cost per test After an infection has ended, and the risk of transmission has passed, people may have detectable RNA and test positive for up to 90 days | Negative tests should be confirmed by NAAT or repeated as [recommended by FDA](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication) Less sensitive (more false negative results) compared to NAATs, especially among asymptomatic people and with some variants |
### Notice
\* As noted in the labeling for authorized over-the-counter antigen tests: negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see [FDA guidance](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety) on the use of at-home COVID-19 antigen tests.
ā The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently.
ā Refers to point-of-care antigen tests only.
## Health Equity in SARS-CoV-2 testing
- Social determinants of health may influence access to testing. For example, travel time may limit access to, and use of, testing services for those who have limited access to transportation and who live in areas with fewer public transit services and schedules. Racial and ethnic disparities in test site distribution have been found2. Other factors that may affect both access to, and use of, testing services include:
- Lack of health insurance
- Concern about the costs or co-pays
- Occupational factors such as not being able to take time off work and lack of paid leave
- Lack of accessible options for people with disabilities, and
- Distrust of the government and healthcare systems3,4,5,6
Delays in testing may also delay seeking care and treatment (when sick) as well as delays in prevention measures that could reduce the spread of the virus to others.
One component to move toward greater health equity is ensuring availability of resources, including access to testing for populations who have experienced longstanding, systemic health and social inequities. All population groups, including racial and ethnic minority groups, should have equal access to affordable, quality, and timely SARS-CoV-2 testingāwith fast turnaround time for results. Efforts should be made to address barriers that might overtly or inadvertently create inequalities in testing.
In addition, completeness of race and ethnicity data is an important factor in understanding the impact the virus has on racial and ethnic minority populations. When possible, healthcare providers and public health professionals should ask and record race and ethnicity for anyone receiving a reportable test result and ensure these data are reported with the personās test results to facilitate understanding the impact of COVID-19 on racial and ethnic minority populations.
Some strategies to achieve health equity in testing access and availability include:
- Use a [social vulnerability index](https://www.atsdr.cdc.gov/place-health/php/svi/?CDC_AAref_Val=https://www.atsdr.cdc.gov/placeandhealth/svi/index.html) to assist in selecting testing sites.
- Increase the availability of free testing sites in communities. Employers, community-based, and faith-based organizations can be important partners to increase the number of free, community-based testing sites. This expansion ensures that wait times both for testing and reporting of results are decreased.
- Increase accessible and culturally appropriate public messaging about the importance of testing and communicate these messages in multiple accessible formats, languages, and venues, particularly in communities at higher risk and disproportionately impacted by the virus.
## Additional information
⢠[Infection Prevention and Control Recommendations for Healthcare Personnel](https://www.cdc.gov/covid/hcp/infection-control/index.html)
⢠[COVID-19 Testing: What You Need to Know (for the public)](https://www.cdc.gov/covid/testing/index.html)
⢠[Laboratory Resources](https://www.cdc.gov/covid/php/lab/reporting-lab-data.html)
## References
1. Morris SB, Schwartz NG, Patel P, et al. [Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection ā United Kingdom and United States, March-August 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7561225/). *MMWR* *Morb Mortal Wkly Rep*. 2020;69(40):1450-1456. Published 2020 Oct 9. doi:10.15585/mmwr.mm6940e1
2. Dalva-Baird NP, Alobuia WM, Bendavid E, Bhattacharya J. [Racial and ethnic inequities in the early distribution of U.S. COVID-19 testing sites and mortality](https://pmc.ncbi.nlm.nih.gov/articles/PMC8420583/). *Eur J Clin Invest*. 2021;51(11):e13669. doi:10.1111/eci.13669
3. Economic Policy Institute. [Black Workers Face Two of the Most Lethal Preexisting Conditions for CoronavirusāRacism and Economic Inequality](https://www.epi.org/publication/black-workers-covid/) \[online\]. 2020 \[cited 2020 Jun 28\].
4. Berchick, Edward R., Jessica C. Barnett, and Rachel D. Upton Current Population Reports, P60-267(RV), [Health Insurance Coverage in the United States: 2018](https://www.census.gov/library/publications/2019/demo/p60-267.html)*,* Government Printing Office, Washington, DC, 2019.
5. Institute of Medicine (US) Committee on the Consequences of Uninsurance. [Care Without Coverage: Too Little, Too Late](https://www.ncbi.nlm.nih.gov/books/NBK220639/)*.* Washington (DC): National Academies Press (US); 2002.
6. Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Smedley BD, Stith AY, Nelson AR, eds. [Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care](https://www.ncbi.nlm.nih.gov/books/NBK220358/). Washington (DC): National Academies Press (US); 2003.
## On This Page
- [Test types](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_1-test-types)
- [Diagnostic testing](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_2-diagnostic-testing)
- [Vaccination and SARS-CoV-2 testing](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_3-vaccination-and-sars-cov-2-testing)
- [Health Equity in SARS-CoV-2 testing](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_4-health-equity-in-sars-cov-2-testing)
- [Additional information](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_5-additional-information)
- [References](https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html#cdc_generic_section_6-references)
## Related Pages
- [Clinical Care Quick Reference](https://www.cdc.gov/covid/hcp/clinical-care/index.html)
- [Clinical Presentation](https://www.cdc.gov/covid/hcp/clinical-care/covid19-presentation.html)
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- [Clinical Care for Outpatients](https://www.cdc.gov/covid/hcp/clinical-care/outpatient-treatment.html)
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[Clinical Course: Progression, Management, and Treatment](https://www.cdc.gov/covid/hcp/clinical-care/management-and-treatment.html)
August 29, 2024
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## Related Pages
- [Clinical Care Quick Reference](https://www.cdc.gov/covid/hcp/clinical-care/index.html)
- [Clinical Presentation](https://www.cdc.gov/covid/hcp/clinical-care/covid19-presentation.html)
- [Clinical Course: Progression, Management, and Treatment](https://www.cdc.gov/covid/hcp/clinical-care/management-and-treatment.html)
- [Clinical Considerations for Special Populations](https://www.cdc.gov/covid/hcp/clinical-care/considerations-special-groups.html)
- [Clinical Care for Outpatients](https://www.cdc.gov/covid/hcp/clinical-care/outpatient-treatment.html)
- [Underlying Conditions and the Higher Risk for Severe COVID-19](https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html)
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| Readable Markdown | August 29, 2024
For Health Care Providers
This overview describes current information on the types of tests used to detect SARS-CoV-2 infection and their intended uses. This information is intended for use by healthcare providers, public health professionals, and those organizing and implementing testing in non-healthcare settings.
## Test types
### Resource
Information for the general public on COVID-19 testing is also [available](https://www.cdc.gov/covid/testing/index.html).
**Viral tests**, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to **detect current infection** with SARS-CoV-2, determine the need for prevention measures, and inform a person's medical care.
### Viral tests
- Nucleic acid amplification tests (NAATs) are highly sensitive and highly specific tests that detect one or more viral ribonucleic acid (RNA) genes. PCR tests are the most common type of NAAT used for COVID-19 testing. Viral RNA may stay in a person's body for up to 90 days after they test positive. Therefore, NAATs should not be used to test someone who has tested positive in the last 90 days. Most NAATs need to be performed in a laboratory, although some are performed at the point-of-care. Most NAATs produce qualitative (positive/negative) results.
- Antigen tests are immunoassays that detect the presence of specific viral proteins, called antigens. A positive test indicates current infection. Antigen tests generally have high specificity, similar to NAATs, but are less sensitive than most NAATs. Because antigen tests have lower sensitivity, [FDA recommends](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions#negative) that negative antigen tests be repeated up to three times, with each test 48 hours apart to confirm a negative result. Most antigen tests are less expensive than NAATs and can provide results in minutes. Antigen tests are available for at-home testing (self-testing), at the point of care, or in a laboratory.
- As noted in the labeling for authorized over-the-counter antigen tests: Negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see [FDA guidance](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions#negative) on the use of at-home COVID-19 antigen tests.
- Other diagnostic tests may be used to detect SARS-CoV-2 from non-traditional respiratory specimens, such as breath. These tests' results may be presumptive and require confirmation by NAAT. Please refer to [each test's Instructions for Use (IFU](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-other-tests-sars-cov-2)) for specific interpretation.
**Positive viral test results** indicate current infection and the person with COVID-19 should take steps to [prevent spreading](https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html) COVID-19 to others.
**Negative viral test results** mean the test did not detect the virus, but this doesn't rule out that the person could have an infection. These results represent a snapshot of the time around specimen collection and could change if the same test was performed again in one or more days. Negative antigen test results should be repeated following [FDA guidance](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety).
**Antibody (or serology) tests** are used to **test for the presence of antibodies** from previous infection or vaccination and can aid in fulfilling the case definition for [multisystem inflammatory syndrome in children (MIS-C)](https://www.cdc.gov/mis/hcp/clinical-overview/index.html) and [adults (MIS-A)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html#cdc_generic_section_2-mis-a-case-definition).1 Antibody testing does not diagnose current infection. Antibody testing is primarily used for public health surveillance and epidemiologic purposes. Antibody tests detect specific antibodies that target different parts (nucleocapsid or spike protein) of the virus. Detection of anti-nucleocapsid antibody indicates SARS-CoV-2 infection, while anti-spike protein antibody may be induced by COVID-19 vaccination or by SARS-CoV-2 infection. This should be considered when choosing whether to test for antibodies originating from past infection versus those from vaccination.
### COVID-19 Test Monitoring
FDA continually monitors the accuracy of COVID-19 tests. Their [website](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests) provides up-to-date information on the impact of viral mutations on COVID-19 tests. See FDA's list of [In Vitro Diagnostics Emergency Use Authorizations](https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas) for more information about the performance and interpretation of specific authorized tests.
## Diagnostic testing
***T**esting individuals with signs or symptoms consistent with COVID-19***
Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT.
Additionally, consider other illnesses with similar symptoms that may require testing. For many diseases, including flu, early diagnosis and prompt treatment can be important for preventing severe illness.
Anyone who tests positive should take steps to [prevent spreading](https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html) COVID-19 to others or, if in a healthcare setting, be placed on [appropriate precautions](https://www.cdc.gov/covid/hcp/infection-control/index.html). Some people should receive [treatment](https://www.cdc.gov/covid/treatment/index.html). Most people with COVID-19 have mild illness and can recover at home.
## Vaccination and SARS-CoV-2 testing
Vaccination does not affect the results of someone's SARS-CoV-2 NAAT, antigen, or other diagnostic tests.
The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA [COVID-19 vaccines](https://www.cdc.gov/covid/vaccines/stay-up-to-date.html#cdc_vaccine_recommendations_reason_benefit-how-well-covid-19-vaccines-work) use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination.
Antibody testing is not currently recommended to assess a person's protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person. Antibody testing can be used in the diagnosis of [Multisystem Inflammatory Syndrome in Children (MIS-C)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html) or [Multisystem Inflammatory Syndrome in Adults (MIS-A)](https://www.cdc.gov/mis/hcp/case-definition-reporting/index.html#cdc_generic_section_2-mis-a-case-definition).
To evaluate for evidence of previous infection in a vaccinated individual, use an antibody test specifically evaluating IgM/IgG to the nucleocapsid protein. For example, specific antibody tests can be used for public health surveillance.
### Table 1. NAAT and Antigen Test\* Differences
| | NAATs | Antigen Tests\* |
|---|---|---|
| **Intended Use** | Diagnose *current* infection | Diagnose *current* infection |
| **Analyte Detected** | Viral ribonucleic acid (RNA) | Viral antigens |
| **Specimen Type(s)** | Nasal, nasopharyngeal, oropharyngeal, sputum, saliva | Nasal, nasopharyngeal |
| **Sensitivity** | Varies by test, but generally high for laboratory-based tests and moderate-to-high for point-of-care (POC) tests | Less sensitive than NAATs. Varies by test and depending on the course of infection+\* |
| **Specificity** | High | High |
| **Test Complexity** | Varies by test | Relatively easy to use |
| **Authorized for Use at the Point of Care** | Most are not, some are | Most are, some are not |
| **Turnaround Time** | Most 1ā3 days; some are rapid with results in 15 minutes | Ranges from 15 minutes to 30 minutes |
| **Cost/Test** | ~\$75-\$100/test | ~\$5-\$50/test |
| **Advantages** | Most sensitive test method available Short turnaround time for NAAT POC tests, but few available Usually does not need to be repeated to confirm results | Short turnaround time (approximately 15 minutes) ā Cost-effective Some can be performed at home, or anywhere else |
| **Disadvantages** | Longer turnaround time for lab-based tests (1ā3 days) Higher cost per test After an infection has ended, and the risk of transmission has passed, people may have detectable RNA and test positive for up to 90 days | Negative tests should be confirmed by NAAT or repeated as [recommended by FDA](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication) Less sensitive (more false negative results) compared to NAATs, especially among asymptomatic people and with some variants |
### Notice
\* As noted in the labeling for authorized over-the-counter antigen tests: negative results should be treated as presumptive (meaning that they are preliminary results). Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please see [FDA guidance](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety) on the use of at-home COVID-19 antigen tests.
ā The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently.
ā Refers to point-of-care antigen tests only.
## Health Equity in SARS-CoV-2 testing
- Social determinants of health may influence access to testing. For example, travel time may limit access to, and use of, testing services for those who have limited access to transportation and who live in areas with fewer public transit services and schedules. Racial and ethnic disparities in test site distribution have been found2. Other factors that may affect both access to, and use of, testing services include:
- Lack of health insurance
- Concern about the costs or co-pays
- Occupational factors such as not being able to take time off work and lack of paid leave
- Lack of accessible options for people with disabilities, and
- Distrust of the government and healthcare systems3,4,5,6
Delays in testing may also delay seeking care and treatment (when sick) as well as delays in prevention measures that could reduce the spread of the virus to others.
One component to move toward greater health equity is ensuring availability of resources, including access to testing for populations who have experienced longstanding, systemic health and social inequities. All population groups, including racial and ethnic minority groups, should have equal access to affordable, quality, and timely SARS-CoV-2 testingāwith fast turnaround time for results. Efforts should be made to address barriers that might overtly or inadvertently create inequalities in testing.
In addition, completeness of race and ethnicity data is an important factor in understanding the impact the virus has on racial and ethnic minority populations. When possible, healthcare providers and public health professionals should ask and record race and ethnicity for anyone receiving a reportable test result and ensure these data are reported with the personās test results to facilitate understanding the impact of COVID-19 on racial and ethnic minority populations.
Some strategies to achieve health equity in testing access and availability include:
- Use a [social vulnerability index](https://www.atsdr.cdc.gov/place-health/php/svi/?CDC_AAref_Val=https://www.atsdr.cdc.gov/placeandhealth/svi/index.html) to assist in selecting testing sites.
- Increase the availability of free testing sites in communities. Employers, community-based, and faith-based organizations can be important partners to increase the number of free, community-based testing sites. This expansion ensures that wait times both for testing and reporting of results are decreased.
- Increase accessible and culturally appropriate public messaging about the importance of testing and communicate these messages in multiple accessible formats, languages, and venues, particularly in communities at higher risk and disproportionately impacted by the virus.
## References
1. Morris SB, Schwartz NG, Patel P, et al. [Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection ā United Kingdom and United States, March-August 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7561225/). *MMWR* *Morb Mortal Wkly Rep*. 2020;69(40):1450-1456. Published 2020 Oct 9. doi:10.15585/mmwr.mm6940e1
2. Dalva-Baird NP, Alobuia WM, Bendavid E, Bhattacharya J. [Racial and ethnic inequities in the early distribution of U.S. COVID-19 testing sites and mortality](https://pmc.ncbi.nlm.nih.gov/articles/PMC8420583/). *Eur J Clin Invest*. 2021;51(11):e13669. doi:10.1111/eci.13669
3. Economic Policy Institute. [Black Workers Face Two of the Most Lethal Preexisting Conditions for CoronavirusāRacism and Economic Inequality](https://www.epi.org/publication/black-workers-covid/) \[online\]. 2020 \[cited 2020 Jun 28\].
4. Berchick, Edward R., Jessica C. Barnett, and Rachel D. Upton Current Population Reports, P60-267(RV), [Health Insurance Coverage in the United States: 2018](https://www.census.gov/library/publications/2019/demo/p60-267.html)*,* Government Printing Office, Washington, DC, 2019.
5. Institute of Medicine (US) Committee on the Consequences of Uninsurance. [Care Without Coverage: Too Little, Too Late](https://www.ncbi.nlm.nih.gov/books/NBK220639/)*.* Washington (DC): National Academies Press (US); 2002.
6. Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Smedley BD, Stith AY, Nelson AR, eds. [Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care](https://www.ncbi.nlm.nih.gov/books/NBK220358/). Washington (DC): National Academies Press (US); 2003.
August 29, 2024 |
| Shard | 5 (laksa) |
| Root Hash | 17308952984333333205 |
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