Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories

FDA has authorized EUAs for both viral and antibody tests for COVID-19. Viral (nucleic acid and antigen) tests are used to diagnose the presence of SARS-CoV-2 infections. In contrast, antibody tests can detect IgG, IgA, and IgM antibodies from an immune response to SARS-CoV-2.

Whenever possible, laboratories should rely on viral tests to diagnose the presence of SARS-CoV-2 infections. However, a negative result from viral testing does not rule out COVID-19.

Most of the PCR-based tests that use two or more targets are likely to have high specificity (few false positives). However, there is some variation in the stated sensitivity of the different assays, and sensitivity is highly dependent on the stage of the disease. For this reason, negative results should always be interpreted in the context of the exposure history and symptoms of the patient.

Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infections or to inform infection status. Negative results from antibody testing do not rule out SARS-CoV-2 infections, particularly for those individuals who have been exposed to the virus and are still within the estimated incubation period. Until the performance characteristics of antibody tests have been evaluated, it is possible that positive results from such testing may be due to past or present infections with a coronavirus other than SARS-CoV-2.

If a laboratory initially uses antibody testing for diagnostic purposes, follow-up testing using a viral test should be performed.

Read: Important Information on the Use of Serological (Antibody) Tests for COVID-19: FDA Letter to Healthcare Providersexternal icon

More: FDA EUA Authorized Serology Test Performanceexternal icon

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