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Protocols Verify Emergency Use Authorization (EUA) SARS-CoV-2 Antibody Tests

June 24, 2020

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SARS-CoV-2 serologic assays that have received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) are important tools for the detection of SARS-CoV-2 antibodies. Serologic tests advance our understanding of epidemiology and seroprevalence rates, play an important role in screening for potential convalescent plasma donors and may be useful in select clinical situations to facilitate the diagnosis of COVID-19. As numerous serologic SARS-COV-2 assays, including lateral flow assays (LFAs), enzyme linked immunosorbent assays (ELISAs) and chemiluminescent immunoassays (CLIAs), are continuing to receive EUA from the FDA, the demand for sensitive and specific SARS-CoV-2 serologic testing is high. Clear guidance is therefore needed to ensure tests are performing properly before data can be collected and accurately interpreted.
 
°®¶¹´«Ã½ has developed step-by-step procedures to help labs develop efficient and effective verification protocols for serologic assays. These guidelines are designed to help validate analytic sensitivity and specificity (reactivity/cross reactivity) and class specificity (IgG/IgM), as well as identify quality control standards, safety requirements and limitations of LFAs, ELISAs and CLIAs.
 
These procedures will help with the verification process, allowing tests to not only be made available faster, but also ensuring that the data are accurate.
 
 

Contact Information

Vaishali Dharmarha, clinmicro@asmusa.org

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