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Chan, Clarence W; Yi, Xin; Lenza, Michael; Baldwin, Angel D; Jakalski, Jennifer; Tesic, Vera; Yeo, Kiang-Teck J

Analytical and Clinical Evaluation of the Semiquantitative Elecsys Anti–SARS-CoV-2 Spike Protein Receptor Binding Domain Antibody Assay on the Roche cobas e602 Analyzer

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  • Media type: E-Article
  • Title: Analytical and Clinical Evaluation of the Semiquantitative Elecsys Anti–SARS-CoV-2 Spike Protein Receptor Binding Domain Antibody Assay on the Roche cobas e602 Analyzer
  • Contributor: Chan, Clarence W; Yi, Xin; Lenza, Michael; Baldwin, Angel D; Jakalski, Jennifer; Tesic, Vera; Yeo, Kiang-Teck J
  • imprint: Oxford University Press (OUP), 2022
  • Published in: American Journal of Clinical Pathology
  • Language: English
  • DOI: 10.1093/ajcp/aqab092
  • ISSN: 0002-9173; 1943-7722
  • Keywords: General Medicine
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Objectives</jats:title> <jats:p>To analytically and clinically evaluate the semiquantitative Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>The S-Ab assay is a 1-step, double-antigen sandwich electrochemiluminescent immunoassay that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 spike protein in serum or plasma. The S-Ab assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin), cross-reactivity, and clinical performance, and was compared to the qualitative Elecsys anti-nucleocapsid (N-Ab) immunoassay, a lateral flow device that qualitatively detects S-Ab and N-Ab, and an anti-spike enzyme-linked immunosorbent assay (ELISA).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>S-Ab assay is precise, exhibits linearity from 0.4 to 250 U/mL, is unaffected by significant cross-reactivity or interferences, and qualitatively demonstrates greater than 90% concordance with N-Ab assay and lateral flow device. Readouts of S-Ab assay correlate with ELISA, which in turn correlates strongly with SARS-CoV-2 virus neutralization assay, and exhibit 100% sensitivity and specificity for COVID-19 patient samples obtained at or more than 14 days after PCR positivity.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>The S-Ab assay is a robust clinical test for qualitative and semiquantitative detection of seropositivity following SARS-CoV-2 infection or spike-encoding mRNA COVID-19 vaccination.</jats:p> </jats:sec>
  • Access State: Open Access