Using Real-World Data to Support Claim Expansion of the Cobas SARS-CoV-2 Test in Asymptomatic Testing: Data from the National Football League Occupational Surveillance Program

Based on data collected during this occupational testing protocol, our study provides strong evidence supporting real-world performance of this test in an asymptomatic population. These findings, complemented by data from an existing clinical study, provided the totality-of-evidence that supported the US Food and Drug Administration clearance for the expanded claim of the candidate test for the qualitative detection of SARS-CoV-2 in the asymptomatic population.