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Tytuł:
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Variable Performance in 6 Commercial SARS-CoV-2 Antibody Assays May Affect Convalescent Plasma and Seroprevalence Screening.
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Autorzy:
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Zilla M; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.
Wheeler BJ; School of Computing and Information, Pittsburgh, PA.
Keetch C; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.
Mitchell G; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.
McBreen J; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.
Wells A; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.; Departments of Pathology, Bioengineering, and Computational and Systems Biology, Pittsburgh, PA.
Shurin MR; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.; Departments of Pathology and Immunology, Pittsburgh, PA.
Peck-Palmer O; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.; Departments of Pathology, Critical Care Medicine, and Clinical and Translational Science, Pittsburgh, PA.
Wheeler SE; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.; Department of Pathology, University of Pittsburgh, Pittsburgh, PA.
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Źródło:
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American journal of clinical pathology [Am J Clin Pathol] 2021 Feb 11; Vol. 155 (3), pp. 343-353.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: 2016- : Oxford : Oxford University Press
Original Publication: Philadelphia [etc.] Lippincott [etc.]
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MeSH Terms:
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Antibodies, Viral/*blood
COVID-19/*blood
COVID-19/*therapy
Enzyme-Linked Immunosorbent Assay/*standards
Enzyme-Linked Immunosorbent Assay/methods ; Humans ; Immunization, Passive ; Plasma ; SARS-CoV-2 ; Sensitivity and Specificity ; Seroconversion ; Seroepidemiologic Studies ; COVID-19 Serotherapy
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Contributed Indexing:
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Keywords: Antibody; COVID-19; Coronavirus; SARS-CoV-2; Serology
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Substance Nomenclature:
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0 (Antibodies, Viral)
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Entry Date(s):
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Date Created: 20201106 Date Completed: 20210218 Latest Revision: 20221207
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Update Code:
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20240105
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PubMed Central ID:
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PMC7665309
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DOI:
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10.1093/ajcp/aqaa228
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PMID:
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33155015
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Objectives: Serologic detection of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is needed for definition of convalescent plasma donors, for confounding SARS-CoV-2 presentation, and for seroprevalence studies. Reliable serologic assays with independent validation are required.
Methods: Six SARS-CoV-2 antibody assays from Beckman Coulter, Euroimmun (IgG, IgA), Roche, and Siemens (Centaur, Vista) were assessed for specificity (n = 184), sensitivity (n = 154), and seroconversion in a defined cohort with clinical correlates and molecular SARS-CoV-2 results.
Results: Assay specificity was 99% or greater for all assays except the Euroimmun IgA (95%). Sensitivity at more than 21 days from symptom onset was 84%, 95%, 72%, 98%, 67%, and 96% for Beckman Coulter, Centaur, Vista, Roche, Euroimmun IgA, and Euroimmun IgG, respectively. Average day of seroconversion was similar between assays (8-10 d), with 2 patients not producing nucleocapsid antibodies during hospitalization.
Conclusions: SARS-CoV-2 nucleocapsid antibodies may be less reliably produced early in disease than spike protein antibodies. Assessment of convalescent plasma donors at more than 30 days from symptom onset and seroprevalence studies should use assays with defined sensitivity at time points of interest because not all assays detected antibodies reliably at more than 30 days.
(© American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
