Evaluation of the Abbott Architect, Roche Elecsys and Virtus S1 SARS-CoV-2 antibody tests in community-managed COVID-19 cases

ABSTRACT

BackgroundAntibody testing can help define how protective immunity to SARS-CoV-2 is and how long this immunity lasts. Many antibody tests have been evaluated in hospitalised rather than community based COVID-19 cases. Virtus Respiratory Research Ltd (Virtus) has developed its own quantitative IgM and IgG SARS CoV-2 antibody assay. We report its validation and performance characteristics and compare its performance with the Abbott Architect and Roche Elecsys assays in community COVID cases. MethodsWe developed a quantitative antibody test to detect IgM and IgG to the SARS-CoV-2 S1 spike protein (the Virtus test) and validated this test in 107 "true positive" sera from 106 community-managed and 1 hospitalised COVID-19 cases and 208 "true negative" serum samples. We validated the Virtus test against a neutralising antibody test. We determined sensitivities of the Abbott test in the 107 true positive samples and the Roche test in a subset of 75 true positive samples. ResultsThe Virtus quantitative test was positive in 93 of 107 (87%) community cases of COVID-19 and both IgM and IgG levels correlated strongly with neutralising antibody titres (r=0.75 for IgM, r=0.71 for IgG, P<0.0001 for both antibodies). The specificity of the Virtus test was 98.6% for low level antibody positives, 99.5% for moderate positives and 100% for high or very high positives. The Abbott test had a sensitivity of 68%. In the 75 sample subset, the Virtus test was positive in 91%, the Roche test in 69%. ConclusionsThe Abbott and Roche tests had sensitives of 68% and 69% respectively in this community set of COVID-19 sera, while the Virtus test had sensitivities of 87% and 91% in the same sample sets. The strong positive correlation with virus neutralization suggests a positive Virtus quantitative antibody test is likely predictive of protective against recurrent COVID-19. FundingThe development of the Virtus test and sample testing with all antibody tests was funded by Virtus Respiratory Research Ltd. The research studies providing 111 of the 208 of the "true negative" samples was supported by MRC Grant numbers MR/M025330/1 and G1100238 and by the National Institute of Health Research (NIHR) Imperial Biomedical Research Centre (BRC), SLJ is a NIHR Emeritus Senior Investigator and is funded in part by European Research Council Advanced Grant 788575 and the Asthma UK Clinical Chair (grant CH11SJ). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.