TY - JOUR
T1 - Application, verification, and implementation of SARS-CoV-2 serologic assays with emergency use authorization
AU - American Society for Microbiology Clinical and Public Health Microbiology Committee, Subcommittee on Laboratory Practices
AU - Theel, Elitza S.
AU - Couturier, Marc Roger
AU - Filkins, Laura
AU - Palavecino, Elizabeth
AU - Mitchell, Stephanie
AU - Campbell, Sheldon
AU - Pentella, Michael
AU - Butler-Wu, Susan
AU - Jerke, Kurt
AU - Dharmarha, Vaishali
AU - McNult, Peggy
AU - Schuetz, Audrey N.
N1 - Funding Information:
Elitza S. Theel received research funding from Ortho-Clinical Diagnostics and serves as an advisor for Roche Diagnostics and Accelerate Diagnostics. Conflicts of interest for Marc Roger Couturier include Apacor and Techcyte (research reagents) and BioFire Diagnostics (household income from spouse). Laura Filkins reports BioFire investigator-initiated study funding. Audrey N. Schuetz serves on the advisory board for Pattern Bioscience. The views expressed in this publication are those of the authors and do not reflect the official policy or position of the Department of the Army, the Department of Defense, or the U.S. Government.
Publisher Copyright:
Copyright © 2020 American Society for Microbiology. All Rights Reserved.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Antibody
KW - Emergency use authorization
KW - Serology
KW - Severe acute respiratory syndrome coronavirus 2
KW - Verification
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U2 - 10.1128/JCM.02148-20
DO - 10.1128/JCM.02148-20
M3 - Review article
C2 - 33020185
AN - SCOPUS:85098508545
SN - 0095-1137
VL - 59
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 1
M1 - e02148-20
ER -