Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) testing is used for serosurveillance and will be important to evaluate vaccination status. Given the urgency to release coronavirus disease 2019 (COVID-19) serology tests, most manufacturers have developed qualitative tests. To evaluate clinical performance of 6 different SARS-CoV-2 IgG assays and their quantitative results to better elucidate the clinical role of serology testing in COVID-19. Six SARS-CoV-2 IgG assays were tested using remnant specimens from 190 patients. Sensitivity and specificity were evaluated for each assay with the current manufacturer's cutoff and a lower cutoff. A numeric result analysis and discrepancy analysis were performed. Specificity was higher than 93% for all assays, and sensitivity was higher than 80% for all assays (≥7 days post-polymerase chain reaction testing). Inpatients with more severe disease had higher numeric values compared with health care workers with mild or moderate disease. Several discrepant serology results were those just below the manufacturers' cutoff. Severe acute respiratory syndrome coronavirus 2 IgG antibody testing can aid in the diagnosis of COVID-19, especially with negative polymerase chain reaction. Quantitative COVID-19 IgG results are important to better understand the immunologic response and disease course of this novel virus and to assess immunity as part of future vaccination programs.
Highlights
Context.—Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) testing is used for serosurveillance and will be important to evaluate vaccination status
Sensitivity analysis for the 6 SARS-CoV-2 IgG assays with their current cutoff ranged from 95.1% (Einstein enzyme-linked immunosorbent assay (ELISA)) to 80.8% (Babson G1)
Given the urgency to develop these tests and lack of standardized material, most SARS-CoV-2 IgG antibody tests were developed and approved as qualitative assays with a positive or negative result reported based on a cutoff value
Summary
Context.—Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) testing is used for serosurveillance and will be important to evaluate vaccination status. Objective.—To evaluate clinical performance of 6 different SARS-CoV-2 IgG assays and their quantitative results to better elucidate the clinical role of serology testing in COVID-19. From the Departments of Pathology (Forest, Orner, Goldstein, Campbell, Cadoff, Weiss, Fox, Prystowsky, Wolgast), Microbiology and Immunology (Wirchnianski, Bortz, Laudermilch, Florez, Chandran), Biochemistry (Malonis, Georgiev, Vergnolle, Lai), and Epidemiology and Population Medicine (Lo), Albert Einstein College of Medicine, Bronx, New York; the Department of Chemistry and Life Sciences, United States Military Academy, West Point, New York (Florez, Barnhill); and the Department of Radiology, Uniformed Services University of Health Science, Bethesda, Maryland (Barnhill). Lai, Fox, Prystowsky, and Weiss are inventors on a patent application related to a COVID-19 diagnostic antibody test. Chandran is an inventor on a patent application related to a COVID19 neutralization assay Both applications are assigned to Albert Einstein College of Medicine. Quantitative COVID-19 IgG results are important to better understand the immunologic response and disease course of this novel virus and to assess immunity as part of future vaccination programs
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