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

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

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Original languageEnglish (US)
Pages (from-to)109-118
Number of pages10
JournalAmerican Journal of Clinical Pathology
Volume157
Issue number1
DOIs
StatePublished - Jan 6 2022

Keywords

  • Anti-spike antibodies
  • Antibodies
  • COVID-19
  • Coronavirus
  • Diagnostics
  • Immunoassay
  • SAR-CoV-2
  • Semiquantitative
  • Serology
  • Spike protein

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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