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FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance

by | Mar 23, 2021

Evolution and mutation of SARS-CoV-2 virus has made COVID-19 diagnosis a moving target. On Feb. 22, 2021, the U.S. Food and Drug Administration issued new guidance telling developers of SARS-CoV-2 tests how to evaluate the impact of viral mutations on test performance. The guidance covers all three types of SARS-CoV-2 tests—molecular, serology and antigen—including both […]

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