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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Evaluation of serological SARS-CoV-2 lateral flow assays for rapid point-of-care testing
Journal of Clinical Microbiology, Volume 59, No. 2, Article e02020-20, Year 2021
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Description
Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays. The performances of 15 different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies were compared on a well-characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (collected an average of 45 days after symptom onset) were used to assess sensitivity. Sixty samples from the prepandemic era (negative control) that were known to represent infections with other respiratory viruses (rhinoviruses A, B, and C and/or coronavirus 229E, HKU1, and NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed using five lateral flow assays (LFAs) and a panel of 272 longitudinal samples from 47 patients for whom the time since symptom onset was known. Among the assays that were evaluated, the sensitivity and specificity for any reactive band ranged from 55% to 97% and from 78% to 100%, respectively. Assessing the performance of the IgM and the IgG bands alone, sensitivity and specificity ranged from 0% to 88% and 80% to 100% for IgM and from 25% to 95% and 90% to 100% for IgG, respectively. Longitudinal testing revealed that the median times after symptom onset to a positive result were 7 days (interquartile range [IQR], 5.4 to 9.8) for IgM and 8.2 days (IQR, 6.3 to 11.3) for IgG. The testing performances differed widely among LFAs, with greatest amount of variation related to the sensitivity of the assays. The IgM band was the band most likely to misclassify prepandemic samples. The appearances of IgM and IgG bands occurred almost simultaneously. Copyright © 2021 American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Manabe, Yukari C.
United States, Baltimore
Johns Hopkins University
Miller, Jernelle
United States, Baltimore
Johns Hopkins University
Klock, Ethan
United States, Baltimore
Johns Hopkins University
Kirby, Charles S.
United States, Baltimore
Johns Hopkins University
Baker, Owen R.
United States, Bethesda
National Institutes of Health Nih
Fernandez, Reinaldo E.
United States, Baltimore
Johns Hopkins University
Eby, Yolanda J.
United States, Baltimore
Johns Hopkins University
Hardick, Justin P.
United States, Baltimore
Johns Hopkins University
Shaw-Saliba, Kathryn
United States, Baltimore
Johns Hopkins University
Rothman, Richard E.
United States, Baltimore
Johns Hopkins University
Caturegli, Patrizio P.
United States, Baltimore
Johns Hopkins University
Redd, Andrew D.
United States, Baltimore
Johns Hopkins University
United States, Bethesda
National Institutes of Health Nih
Tobian, Aaron A.R.
United States, Baltimore
Johns Hopkins University
Bloch, Evan M.
United States, Baltimore
Johns Hopkins University
Larman, Harry Benjamin
United States, Baltimore
Johns Hopkins University
Quinn, Thomas Charles
United States, Baltimore
Johns Hopkins University
United States, Bethesda
National Institutes of Health Nih
Clarke, William A.
United States, Baltimore
Johns Hopkins University
Laeyendecker, Oliver B.
United States, Baltimore
Johns Hopkins University
United States, Bethesda
National Institutes of Health Nih
Statistics
Citations: 31
Authors: 18
Affiliations: 2
Identifiers
Doi:
10.1128/JCM.02020-20
ISSN:
00951137
Research Areas
Covid
Study Design
Cohort Study