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. 2020 Dec 17;59(1):e02148-20.
doi: 10.1128/JCM.02148-20. Print 2020 Dec 17.

Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

Elitza S Theel  1 , Marc Roger Couturier  2   3 , Laura Filkins  4 , Elizabeth Palavecino  5 , Stephanie Mitchell  6 , Sheldon Campbell  7   8 , Michael Pentella  9   10 , Susan Butler-Wu  11 , Kurt Jerke  12 , Vaishali Dharmarha  13 , Peggy McNult  13 , Audrey N Schuetz  14
Affiliations

Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

Elitza S Theel et al. J Clin Microbiol. .

Abstract

Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single-antibody and multiantibody isotype detection assays, which may provide either differentiated or nondifferentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays.

Keywords: antibody; emergency use authorization; serology; severe acute respiratory syndrome coronavirus 2; verification.

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References

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