Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays

Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW (R) and Sofia (R)). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms <= 7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia (R), BinaxNOW (TM), and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia (R), and 82% (73% - 88%) BinaxNOW (TM). The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.