Performance of a rapid SARS-COV-2 serology test in whole blood and separated plasma

Vemulapati, S.

Rapid SARS-COV-2 related serology testing can help identify and manage the spread of infection in decentralized testing environments but the limitation in performance of existing tests in blood has restricted implementation of testing at the point-of-care. Optimization of existing rapid tests in whole blood will require significant effort in the short-term and there is a need for solutions to help bridge the gap in performance between plasma and whole blood. We demonstrate here the implementation of the H.E.R.M.E.S platform, a portable plasma separation system that can enhance the performance of blood-based diagnostic testing, with a commercially available SARS-COV-2 IgG/IgM serology rapid diagnostic test (RDT) in a blinded study with 61 human samples. We compare the performance of the RDT in whole blood and separated plasma and highlight that plasma yields a 39% increase in positivity agreement with PCR in samples collected from patients with early infections. We further legitimize the increase in positivity agreement rate with the help of an independent evaluation by 10 previously untrained users. The H.E.R.M.E.S plasma separation system circumvents the need for assay optimization in whole blood and furthers the legitimacy of incorporating SARS-COV-2 serology RDTs at the point-of-care. The data highlighted in this work makes a compelling case for the incorporation of the H.E.R.M.E.S system in large scale efforts to perform SARS-COV-2 serology testing in decentralized testing environments.