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

Author:

Theel Elitza S.1ORCID,Couturier Marc Roger23,Filkins Laura4,Palavecino Elizabeth5,Mitchell Stephanie6ORCID,Campbell Sheldon78,Pentella Michael910,Butler-Wu Susan11ORCID,Jerke Kurt12,Dharmarha Vaishali13,McNult Peggy13,Schuetz Audrey N.1ORCID

Affiliation:

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

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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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