Utility of Roche Elecsys anti-SARS-CoV-2 S in ascertaining post-vaccine neutralizing antibodies

Abstract

With widespread global COVID-19 vaccine coverage, a scalable, cost-effective, and standardized tool to ascertain post-vaccine immunity is a dire need. Neither clinical evaluations of vaccine efficacy, nor live virus antibody neutralization assays fulfill these criteria. Commercially available anti-S binding immunological assays have the potential to fill this gap, but need to be systematically evaluated for their utility to serve as surrogates for the aforementioned, widely accepted tools of determining vaccine efficacy. In this study, we evaluated an anti-S binding immunological assay (Roche Elecsys Anti-SARS-CoV-2 S) by utilizing two hundred and fifty-five archived serum specimens, either pre-pandemic, or those exposed to natural infections or vaccines with their neutralizing titers pre-determined through a live virus, pseudotyped antibody neutralization assay. Roche Elecsys Anti-SARS-CoV-2 S demonstrated good sensitivity (98%) and specificity (99%), just as has been reported in some other previously conducted studies using this assay. Only a mild correlation, however, with the live virus pseudotyped lentivirus antibody neutralization assay (Spearman's r = 0.26) was observed. We conclude that, as such, Elecsys Anti-SARS-CoV-2 S has a high sensitivity and specificity for detecting anti-SARS-CoV-2 S proteins, though the assay does not always correlate well with live virus assays for quantitative outcomes.