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Variable Performance in 6 Commercial SARS-CoV-2 Antibody Assays May Affect Convalescent Plasma and Seroprevalence Screening.
Zilla, Megan; Wheeler, Bradley J; Keetch, Christian; Mitchell, Gretchen; McBreen, Jeffrey; Wells, Alan; Shurin, Michael R; Peck-Palmer, Octavia; Wheeler, Sarah E.
  • 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.
  • Shurin MR; Departments of Pathology, Bioengineering, and Computational and Systems Biology, Pittsburgh, PA.
  • Peck-Palmer O; Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA.
  • Wheeler SE; Departments of Pathology and Immunology, Pittsburgh, PA.
Am J Clin Pathol ; 155(3): 343-353, 2021 02 11.
Article in English | MEDLINE | ID: covidwho-913143
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Am J Clin Pathol Year: 2021 Document Type: Article Affiliation country: Ajcp

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Am J Clin Pathol Year: 2021 Document Type: Article Affiliation country: Ajcp