A peer-reviewed study by researchers at NSF International and Novateur Ventures has found significant variability in the accuracy of commercially available Covid-19 antibody tests.
Published independent performance data of five chemiluminescence immunoassay (CLIA), 15 enzyme-linked immunosorbent assay (ELISA) and 42 rapid diagnostic (RD) antibody tests that are currently on the market were reviewed for this study to understand their limits and potential. Overall, 13 top-performing antibody tests were identified based on independent evaluations of their sensitivity and specificity data (>95% accuracy).
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Novateur Ventures advisor in scientific affairs Abdi Ghaffari said: “Granting FDA Emergency Use Authorization to several companies to accelerate the manufacturing of diagnostic tests was a good move, but it must be accompanied by informed and clear guidelines on preferred and minimally acceptable profiles of the Covid-19 antibody tests designed for a specific indication.”
