Performance evaluation of antibody-based point-of-care devices intended for the identification of immune responses to SARS-CoV-2

Furuya, Andrea K.M.; Wagner, Christine; Connors, Julia; Bodnar, Janine; Miller, Thomas; Ryman, Nko Lea; Warszycki, Casey J.; Wong, Susan J.; Walsh, Anne C.; McDonough, Kathleen A.; Lee, William T.

The novel coronavirus outbreak caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) was first identified in December of 2019 in Wuhan, China. The local outbreak quickly rose to pandemic level that has spread to more than 188 countries with more than 19 million cases and 732 467 deaths worldwide. The current recommendation for testing is RT-PCR based tests of nasopharyngeal or alternatively nasal- and/or oropharyngeal swabs that detect infection with SARS-CoV-2 to diagnose acute infection. However, there is an urgent need for a quick and accurate antibody-based point-of-care (POC) test method to quickly identify evidence of SARS-CoV-2 infection among people who might be missed through active case finding and surveillance efforts. Serology tests measure the presence of antibodies in serum after infection. Here we compared the performance characteristics of six commercially available antibody-based POC devices and their potential for identification of individuals infected at some time by SARS-CoV-2.