EXPRESS: Evaluation of the MP Rapid 2019-NCOV IgM/IgG Combo POCT test vs an established platform-based method.

Jassam, Nuthar; Barth, Julian H; Allgar, Victoria; Glover, Sarah; Stevenson, Fiona; Lauber, Neil; Houghton, Victoria; Hanif, Zeb; Child, Jenny; Clark, Brendan

BACKGROUND Accurate and rapid testing for SARS-COV-2 antibodies could improve the diagnosis and management of COVID-19. In this study we aim to evaluate the diagnostic accuracy of a commercially available point of care lateral flow kit independently and in comparison to an established platform based system. METHOD Samples from 144 PCR-confirmed COVID-19 cases and 130 pre-pandemic negative controls were tested in parallel by MP Rapid 2019-NCOV IgM/IgG Combo test and Roche Elecsys. Comparison of results based on serum and capillary blood testing was undertaken. RESULTS Sensitivity at day 15 onwards was 100% for both methods. Between days 1 and 7 post admission, the IgM/IgG Combo test and Roche Elecsys shown sensitivity of (74% (95%CI: 62%-85%) vs 67% (95% CI: 55%-79%, p=0.3947). Combo test specificities were 100% for IgG, 98.5% for IgM. vs Roche Elecsys specificity of 100%. Concordance analysis showed 98.5% agreement to the Roche Elecsys method (Cohenâs Kappa 0.96 95% CI (0.92-0.99)). Capillary blood results showed complete agreement with serum samples using the Combo test.Conclusion; In comparison to Roche Elecsys, our data shows that the MP Rapid 2019-NCOV IgM/IgG Combo test provides a high-confidence assay system for the detection of previous exposure to SARS-COV-2 infection with advantage of affording near-patient testing.