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Jerke, Kurt

A5020832678 | I1330654748

Mayo Clinic

Madigan Army Medical Center

Citations 1

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

Journal of Clinical Microbiology | October 6, 2020 | Volume: 59 | Issue: 1 | Pages: No page available

10.1128/jcm.02148-20 | PMID 33020185

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.