FDA approves at-home rapid test for influenza, COVID-19
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The FDA issued an emergency use authorization for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, according to an FDA roundup news release.
The test, manufactured by CorDx Inc., is for individuals displaying respiratory infection symptoms consistent with COVID-19 within the first 5 days of symptom onset. The single-use test is intended to detect and differentiate influenza A and B and SARS-CoV-2. According to the CorDx website, the 3-in-1 multiplex test is a lateral flow immunoassay device that provides a novel 10-minute diagnostic solution using samples collected via nasal swabs.
Samples can be self-collected by individuals aged 14 years and older, whereas those aged younger down to age 2 years should have nasal swab specimens collected by an adult, according to the FDA release.
The FDA’s decision to issue an emergency use authorization for the CorDx at-home test was based on validation data gathered through the NIH Independent Test Assessment Program, which was established as an FDA and NIH collaboration.
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- CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test. https://cordx.com/product/zt2/cordx-tyfast-flu-a-b-covid-19-at-home-multiplex-rapid-test. Accessed April 5, 2024.
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