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FDA Creates Path for Development of At-Home COVID-19 Testing


The United States Food and Drug Administration (FDA) released a template for companies to use in obtaining emergency use authorization for rapid COVID-19 testing that can be performed in homes, offices, schools, and other non-medical settings without a prescription. The template provides guidance on the baseline for performance, including sensitivity and specificity, and how samples should be collected and analyzed. While the sensitivity of such tests will not be as reliable as laboratory-based tests, the FDA asserts that the potential benefits of improved access to testing outweigh this risk. Read more here.

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