SARS-CoV-2 Serology: Much Hype, Little Data

Abstract

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), has led to significant morbidity and mortality throughout the world ( 1,). In response to a lack of COVID-19 testing the FDA issued guidance regarding serologic assays, stating that although manufacturers could use the Emergency Use Authorization (EUA) pathway for approval, serologic assays could also be marketed in the US bypassing this approval process ( 2,). This has led to a dramatic availability of serologic tests, most of which are from companies with little to no track record in the in vitro diagnostic market. At the time of writing, more than 100 manufacturers have notified the FDA that they are offering or plan to offer serologic testing in the US and only 4 have received EUA ( 3). This represents an unprecedented release of manufacturer developed laboratory tests that have not been reviewed by the FDA. Some have appeared in nonpeer-reviewed preprint servers and have both gained attention and generated criticism in the lay press. Nonetheless, calls for COVID-19 serologic testing have continued to gain momentum. Serology has been suggested to have 3 roles in the COVID-19 pandemic; (a) diagnosis, (b) identification of convalescent plasma donors, and (c) screening populations with the purpose of determining exposure and immunity.