1. 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.
- Author
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Tacker DH, Bashleben C, Long TC, Theel ES, Knight V, Kadkhoda K, Rhoads DD, Linden MA, and Fink SL
- Subjects
- COVID-19 blood, COVID-19 immunology, COVID-19 virology, Humans, Immunoglobulin G blood, Reproducibility of Results, United States, Antibodies, Viral blood, COVID-19 diagnosis, COVID-19 Serological Testing methods, COVID-19 Serological Testing standards, Laboratory Proficiency Testing, SARS-CoV-2 immunology
- 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., (© 2021 College of American Pathologists.)
- Published
- 2021
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