I've heard about antibody testing for COVID-19. What is antibody testing? Is it the same as testing to diagnose COVID-19?
Answer From William F. Marshall, III M.D.
With all the talk about coronavirus disease 2019 (COVID-19) testing in the news, it's not surprising that there's confusion about tests and how they differ. Antibody testing determines whether you had COVID-19 in the past and now have antibodies against the virus. A test to diagnose COVID-19 determines if you currently have the disease. Here's what you need to know about testing.
When is antibody testing done and why is it important?
Antibody testing, also known as serology testing, is usually done after full recovery from COVID-19. Eligibility may vary, depending on the availability of tests. A health care professional takes a blood sample, usually by a finger prick or by drawing blood from a vein in the arm. Then the sample is tested to determine whether you've developed antibodies against the virus. The immune system produces these antibodies — proteins that are critical for fighting and clearing out the virus.
If test results show that you have antibodies, it indicates that you were likely infected with COVID-19 at some time in the past. It may also mean that you have some immunity. But there's a lack of evidence on whether having antibodies means you're protected against reinfection with COVID-19. The level of immunity and how long immunity lasts are not yet known. Ongoing studies will eventually reveal more data on this.
The timing and type of antibody test affects accuracy. If you have testing too early in the course of infection, when the immune response is still building up in your body, the test may not detect antibodies. So antibody testing is not recommended until at least 14 days after the onset of symptoms. The U.S. Food and Drug Administration (FDA) authorized specific antibody tests, but tests with questionable accuracy are still on the market.
Another benefit of accurate antibody testing is that people who've recovered from COVID-19 may be eligible to donate plasma, a part of their blood. This plasma could be used to treat others with severe disease and boost the ability to fight the virus. Doctors call this convalescent plasma.
What tests are used to diagnose COVID-19?
The FDA approved these types of tests for diagnosing a COVID-19 infection:
- PCR test. Also called a molecular test, this COVID-19 test detects genetic material of the virus using a lab technique called polymerase chain reaction (PCR). A fluid sample is collected with a nasal swab or a throat swab, or you may spit into a tube to produce a saliva sample. Results may be available in minutes if analyzed onsite or a few days — or longer in locations with test processing delays — if sent to an outside lab. PCR tests are very accurate when properly performed by a health care professional, but the rapid test can miss some cases.
- Antigen test. This COVID-19 test detects certain proteins in the virus. Using a nasal swab to get a fluid sample, antigen tests can produce results in minutes. Others may be sent to a lab for analysis. A positive antigen test result is considered accurate when instructions are carefully followed, but there's an increased chance of false-negative results — meaning it's possible to be infected with the virus but have a negative result. Depending on the situation, the doctor may recommend a PCR test to confirm a negative antigen test result.
The FDA granted emergency use authorization for certain at-home COVID-19 test kits. You can collect your own sample of nasal fluid or saliva at home. Most of these tests require a doctor's prescription. The accuracy of these tests varies, so a negative test does not completely rule out having the COVID-19 virus. Only get an at-home test that's authorized by the FDA or approved by your local health department.
What do I do if I'm interested in a COVID-19 diagnostic test or an antibody test?
You can contact your local or state health department or visit the department's website for information on testing. If you have symptoms of COVID-19, contact your doctor to discuss your situation and find out how to prepare for your appointment before seeking a COVID-19 test in person.
Access to either test depends on where you live, test availability and whether you're viewed as eligible. In the U.S., collaborative efforts to make more tests available are ongoing. The nationwide goal is to test more people as more tests become available.
How can diagnostic and antibody testing help reduce the spread of COVID-19?
With COVID-19 diagnostic testing, people who test positive and have symptoms can get care earlier. Contacts can be traced and self-isolation or quarantine started sooner to help stop the spread of the virus.
But no COVID-19 test is 100% accurate. It's possible to test negative yet actually be infected (false-negative result) or to test positive and not be infected (false-positive result). So it's vital to continue to follow COVID-19 guidelines from the Centers for Disease Control and Prevention, such as social distancing and wearing a mask when appropriate, until further notice.
Results of antibody tests indicate how many people had COVID-19 and recovered, including those who didn't have symptoms. This aids in determining who might have immunity, though to what extent and for how long is not yet known.
William F. Marshall, III M.D.
Dec. 12, 2020
- AskMayoExpert. COVID-19: Testing — Suspected COVID-19: PCR testing. Mayo Clinic; 2020.
- Patel R, et al. Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of diagnostic testing for SARS-CoV-2/COVID-19. MBio. 2020; doi:10.1128/mBio.00722-20.
- Evaluating and testing persons for Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html. Accessed Oct. 28, 2020.
- EUA authorized serology test performance. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance. Accessed Oct. 28, 2020.
- Beware of fraudulent coronavirus tests, vaccines and treatments. U.S. Food & Drug Administration. https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments. Accessed Oct. 29, 2020.
- West CP, et al. COVID-19 testing: The threat of false-negative results. Mayo Clinic Proceedings. 2020; doi: 10.1016/j.mayocp.2020.04.004.
- Coronavirus (COVID-19) update: Serological tests. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests. Accessed April 16, 2020.
- Mayo Clinic. EAP for convalescent plasma no longer enrolling; the FDA authorized emergency use. https://www.uscovidplasma.org. Accessed Nov. 3, 2020.
- Abbasi J. The promise and peril of antibody testing for COVID-19. JAMA. 2020; doi:10.1001/jama.2020.6170.
- Coronavirus (COVID-19) update: Serological test validation and education efforts. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts. Accessed April 28, 2020.
- "Immunity passports" in the context of COVID-19. World Health Organization. https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19. Accessed April 29, 2020.
- IDSA COVID-19 antibody testing primer. Infectious Diseases Society of America. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf. Accessed Oct. 30, 2020.
- Coronavirus (COVID-19) update: FDA authorizes first test for patient at-home sample collection. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection. Accessed April 29, 2020.
- Coronavirus testing basics. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics?utm_campaign. Accessed Oct. 30, 2020.
- Coronavirus Disease 2019 (COVID-19): COVID-19 testing overview. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Accessed Oct. 30, 2020.
- Coronavirus (COVID-19) update: FDA authorizes first diagnostic test using at-home collection of saliva specimens. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva. Accessed May 12, 2020.
- Coronavirus (COVID-19) update: FAQs on Testing for SARS-CoV-2. What is the difference between the types of tests available for SARS-CoV-2? U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#5eb3418a8c19f. Accessed Oct. 27, 2020.
- Coronavirus (COVID-19) update: FDA authorizes first antigen test to help in the rapid detection of the virus that causes COVID-19 in patients. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes. Accessed May 14, 2020.
- Marshall, WF III (expert opinion). Mayo Clinic. Aug. 15, 2020.
- Coronavirus (COVID-19) update: FDA posts new template for at-home and over-the-counter diagnostic tests for use in non-lab settings, such as homes, offices or schools. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non. Accessed Aug. 11, 2020.
- Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2 — Letter to clinical laboratory staff and health care providers. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-results-antigen-tests-rapid-detection-sars-cov-2-letter-clinical-laboratory. Accessed Nov. 4, 2020.
- Coronavirus Disease 2019 (COVID-19): Using antibody tests for COVID-19. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests.html. Accessed Nov. 4, 2020.
- AskMayoExpert. COVID-19: Testing — Serologic antibody testing. Mayo Clinic; 2020.
- COVID-19 nasal swab type now determined at time of collection and may limit test "add-on" options: IP nurses will still complete the NP swab. Physical Medicine and Rehabilitation Newsletter — RST. Mayo Clinic. Nov. 18, 2020.
- Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home. Accessed Nov. 19, 2020.
- Interim guidance for antigen testing for SARS-CoV-2. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html. Accessed Dec. 10, 2020.
- Coronavirus (COVID-19) update: FDA authorizes first direct-to-consumer COVID-19 test system. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-direct-consumer-covid-19-test-system. Accessed Dec. 10, 2020.