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FDA Warns Of False Negatives Resulting From New COVID-19 Strain

By Kelly Lienhard / January 11, 2021 at 3:01 PM
FDA is working to identify new mutant strains of COVID-19 and analyze how they respond to current diagnostic tests, agency chief Stephen Hahn told reporters on a Friday (Jan. 8) press briefing, just a few hours before FDA alerted health care providers it has identified three emergency authorized tests that could produce false negative results with a potential mutated variant of SARS-CoV-2. Accula’s SARS-CoV-2 test, TaqPath’s COVID-19 Combo Kit and Linea’s COVID-19 Assay Kit could be impacted by genetic mutations...


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