The Role of Antibody Testing for SARS-CoV-2: Is There One?-Reference-Cited by-同舟云学术

The Role of Antibody Testing for SARS-CoV-2: Is There One?

Published:2020-07-23 Issue:8 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Theel Elitza S.¹,Slev Patricia²³,Wheeler Sarah⁴,Couturier Marc Roger²³,Wong Susan J.⁵,Kadkhoda Kamran⁶

Affiliation:

1. Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA

2. ARUP Laboratories, Salt Lake City, Utah, USA

3. Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA

4. Division of Clinical Immunopathology, Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA

5. Wadsworth Center, New York State Department of Health, Albany, New York, USA

6. Immunopathology Laboratory, Robert J. Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio, USA

Abstract

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) brought with it rapid development of both molecular and serologic assays for identification of COVID-19 infections. While Food and Drug Administration (FDA) emergency use authorization (EUA) is required for clinical application of SARS-CoV-2 molecular tests, submission for EUA is currently a voluntary process for manufacturers of serologic assays. The absence of FDA oversight of serologic tests is concerning given that the commercially available serologic assays are highly variable, differing in their format, the antibody class detected, the targeted antigen, and the acceptable specimen types.

Funder

Mayo Clinic

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.00797-20

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