Intended Use: The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. The Flowflex SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
Objective: A multi-site clinical study was conducted in China and USA to evaluate the performance of the Flowflex SARS-CoV-2 Antigen Rapid Test when compared to RT-PCR method.
Study AcceptanceCriteria: Total Sensitivity≥85%, Total Specificity≥98%
Study Conclusions: Using a total of 605 specimens tested at multiple sites in U.S and China, the Flowflex SARS-CoV-2 Antigen Rapid Test has sensitivity of 97.1%, specificity of 99.5%, and accuracy of 98.8% when comparing with FDA EUA RT-PCR.