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

Elitza S Theel; Marc Roger Couturier; Laura Filkins; Elizabeth Palavecino; Stephanie Mitchell; Sheldon Campbell; Michael Pentella; Susan Butler-Wu; Kurt Jerke; Vaishali Dharmarha; Peggy McNult; Audrey N Schuetz

doi:10.1128/JCM.02148-20

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

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

Authors

Elitza S Theel¹, Marc Roger Couturier^{2

3}, Laura Filkins⁴, Elizabeth Palavecino⁵, Stephanie Mitchell⁶, Sheldon Campbell^{7

8}, Michael Pentella^{9

10}, Susan Butler-Wu¹¹, Kurt Jerke¹², Vaishali Dharmarha¹³, Peggy McNult¹³, Audrey N Schuetz¹⁴

Affiliations

¹ Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
² Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
³ ARUP Laboratories, Salt Lake City, Utah, USA.
⁴ Department of Pathology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁵ Department of Pathology, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
⁶ Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁷ Department of Laboratory Medicine, Yale School of Medicine, West Haven, Connecticut, USA.
⁸ Department of Pathology and Laboratory Medicine, VA Connecticut Health Care, West Haven, Connecticut, USA.
⁹ College of Public Health, University of Iowa, Iowa City, Iowa, USA.
¹⁰ State Hygienic Laboratory, University of Iowa, Coralville, Iowa, USA.
¹¹ Department of Pathology, Keck School of Medicine of USC, Los Angeles, California, USA.
¹² Department of Pathology and Area Laboratory Services, Madigan Army Medical Center, Joint Base Lewis-McChord, Washington, USA.
¹³ American Society for Microbiology, Washington, DC, USA.
¹⁴ Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA schuetz.audrey@mayo.edu.

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Neutralizing / blood
Antibodies, Viral / blood*
COVID-19 / diagnosis*
COVID-19 Serological Testing / methods*
Humans
Predictive Value of Tests
SARS-CoV-2 / immunology*
United States
United States Food and Drug Administration

Substances

Antibodies, Neutralizing
Antibodies, Viral