The Food and Drug Administration (FDA) is making it easier for people to self-test for COVID-19 and the flu simultaneously at home.
This week, the agency approved Healgen Scientific’s Rapid Check COVID-19/Flu A&B antigen test for home use without a prescription. Other at-home combination tests that can detect both COVID-19 and influenza already exist, but they are currently only available under emergency use authorization.
The Healgen test is the first combined at-home COVID-19 and flu test approved for sale for non-emergency use.
“As we enter this year’s flu season with respiratory illnesses like COVID-19 on many of our minds, our ability to effectively and efficiently detect these pathogens could impact our daily lives,” Michelle said. Dr. Tarver said. The FDA’s Center for Devices and Radiological Health said in a statement Monday. “Today’s approval expands the options for individuals with respiratory symptoms to receive health information from the comfort of their own home.”
Healgen.com
Like other viral test kits on the market, Healgen’s product uses nasal swab samples to identify proteins from SARS-CoV-2 (the virus that causes COVID-19) or Influenza A and B (the virus that causes COVID-19). Detect whether it is present or not. the two most common flu strains). According to the FDA, results from at-home tests for COVID-19 and the flu appear in about 15 minutes.
The Hilgen test is intended for self-use by individuals 14 years of age or older, or children 2 years of age or older if administered by adults. According to the FDA analysis, the test correctly identified 99% of SARS-CoV-2 negative samples and 92% of positive samples. 99.9% of influenza A and B samples were negative; The positivity rates for flu A and flu B samples were 92.5% and 90.5%, respectively.
“As with all rapid antigen tests, which are generally less sensitive than molecular tests, there is a risk of false-negative test results,” the FDA said, adding that individuals with persistent symptoms should seek follow-up with a health care provider.
