Dataset Information

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.

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.

SUBMITTER: Chan CW

PROVIDER: S-EPMC8499855 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Critical evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays is needed to guide clinical decision-making and ensure that these assays provide optimal benefit to patients and the public. Here, three commercially available assays with widespread distribution capabilities are compared. A total of 667 specimens, 103 from patients with confirmed SARS-CoV-2 infections and 564 collected prior to the emergence of SARS-CoV-2, were analyzed in parallel using the Roche Elecsys SARS-CoV-2 total antibody and Abbott Alinity SARS-CoV-2 IgG assays; a subset of 55 samples from patients with confirmed SARS-CoV-2 infections was additionally evaluated using the Abbott Architect SARS-CoV-2 IgM assay. Qualitative agreement between the Abbott IgG and Roche total antibody assays was 98.7% (658/667), with Cohen's kappa value of 0.919 (95% confidence interval [CI], 0.867 to 0.972). Qualitative agreements with the Abbott IgM assay were 92.7% (51/55, Abbott IgG) and 85.5% (47/55, Roche total antibody). Diagnostic specificities determined using pre-COVID-19 samples for the Abbott IgG and Roche total antibody assays were 99.65% (95% CI, 98.72 to 99.90%) and 100.00% (95% CI, 99.32 to 100.00%), respectively, spanning claims made by each manufacturer. Diagnostic sensitivities increased for all three assays with increasing time since the onset of symptoms. Among 51 patients with confirmed SARS-CoV-2 infections, 23 (45.1%), 24 (47.1%), and 22 (43.1%) were reactive by the Abbott IgG, Roche total antibody, and Abbott IgM assays, respectively, with sampling times 0 to 56 days post-positive PCR (median/mean, 2/6.2 days). Combining IgG and IgM screening identified 4/55 additional samples with detectable antibodies that would not have been observed using the assays independently. Notably, one immunocompromised patient with confirmed SARS-CoV-2 infection showed no detectable antibodies using any of the three assays 43 days after onset of symptoms.