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Writer's pictureOluchukwu M. Ezeala

FDA Grants Marketing Authorization for Single COVID-19 and Flu Test Kit.

Earlier this month, the U.S. Food and Drug Administration (FDA) approved the marketing of Healgen’s Rapid COVID-19/Flu A and B antigen combination test. This test is available over the counter (OTC) and is the first OTC COVID-19/Flu test to be approved outside of emergency use authorization. The test is effective in detecting SARS-CoV-2, the virus that causes COVID-19, as well as influenza A and B, which cause the flu. In a clinical study, the test correctly identified 99% of negative samples, and 90.5%–92.5% of positive samples for SARS-CoV-2 and influenza A and B. According to the FDA, this test can be used for those aged 2 years and older who show respiratory symptoms, and results can usually be expected within 15 minutes. Read more at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use?utm_source=MarketingCloud&utm_medium=email&utm_campaign=PT+Daily+October+8&utm_content=PT+Daily+October+8




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