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. 2021 May 1;145(5):536-542.
doi: 10.5858/arpa.2020-0811-SA.

Interlaboratory Agreement of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serologic Assays in the Expedited College of American Pathologists Proficiency Testing Program

Danyel H Tacker  1 , Christine Bashleben  2 , Thomas C Long  3 , Elitza S Theel  4 , Vijaya Knight  5 , Kamran Kadkhoda  6 , Daniel D Rhoads  7 , Michael A Linden  8 , Susan L Fink  9
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Interlaboratory Agreement of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serologic Assays in the Expedited College of American Pathologists Proficiency Testing Program

Danyel H Tacker et al. Arch Pathol Lab Med. .

Abstract

Context.—: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a recently emerged, currently pandemic virus, and the etiologic agent of coronavirus disease 2019 (COVID-19). Clinical testing for antibodies to SARS-CoV-2 has rapidly become widespread, but data regarding the interlaboratory performance of these serologic assays are limited.

Objective.—: To describe the development and initial results of the College of American Pathologists (CAP) SARS-CoV-2 Serology Survey.

Design.—: Members from the CAP Microbiology and Diagnostic Immunology and Flow Cytometry Committees formed a working group to support development of a new proficiency testing survey for anti-SARS-CoV-2 antibody assays. Supplemental questions in the survey assessed the state of SARS-CoV-2 serologic testing among participating laboratories as of July 2020. Results were analyzed for agreement by immunoglobulin (Ig) isotype tested, assay manufacturer, and methodology.

Results.—: A total of 4125 qualitative results were received from 1110 laboratories participating in the first survey. Qualitative agreement for assays measuring anti-SARS-CoV-2 total antibodies or IgG was greater than 90% for all 3 samples in the survey. Qualitative agreement for IgM and IgA for the negative sample was greater than 95%, but lacked consensus for the other 2 samples.

Conclusions.—: These initial data suggest overall excellent agreement and comparable performance for most qualitative anti-SARS-CoV-2 IgG and total antibody assays across all participating clinical laboratories, regardless of specific target antigen or assay methodology.

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Figures

Figure 1.
Figure 1.. Supplemental Question 2 Responses
Pareto Chart of Responses to Supplemental Question 2 on the COVS-A 2020 Proficiency Testing survey. Left y-axis, count of binned responses; right y-axis, cumulative percent of responses; x-axis, reported volume in bins.
See this image and copyright information in PMC

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