Application, verification, and implementation of SARS-CoV-2 serologic assays with emergency use authorization

American Society for Microbiology Clinical and Public Health Microbiology Committee, Subcommittee on Laboratory Practices

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish (US)
Article numbere02148-20
JournalJournal of clinical microbiology
Volume59
Issue number1
DOIs
StatePublished - Jan 2021

Keywords

  • Antibody
  • Emergency use authorization
  • Serology
  • Severe acute respiratory syndrome coronavirus 2
  • Verification

ASJC Scopus subject areas

  • Microbiology (medical)

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