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Modern Healthcare Illustration / Getty Images With rapid antigen tests for SARS-CoV-2 slow to come to market, officials at the US Food and Drug Administration have tried to signal via a number of public comments that the agency would be flexible regarding test performance requirements and use models. These indications of flexibility have largely failed to speed development and commercialization of rapid antigen tests, however, as test vendors, wary of falling short of agency requirements, have instead stuck to the more stringent specifications presented in the FDA s test templates. Early in the COVID-19 pandemic, rapid antigen tests were identified as a potentially key technology for slowing transmission of SARS-CoV-2 with calls for these tests growing as it became evident that molecular test capacity was not able to keep up with demand and was unlikely to ever reach a level where regular testing at population scale would be possible.

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