They have been authorized by the FDA under an emergency use authorization. The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older. The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. As COVID-19 continues to evolve, recent research and regulatory guidance has confirmed that frequent testing – particularly when you are unsure when you were exposed – can increase the chances of catching the virus when it is detectable in people with or without symptoms. One of the benefits of at-home tests is that they can be done frequently and provide answers within minutes. Why is that? While the Omicron variant contains mutations to the spike protein, our tests do not rely on the spike gene to detect the virus. Our team of researchers have confirmed that our BinaxNOW tests continue to detect the Omicron variant and its sub-variants, including XBB.1.5. And to have perpetually confounding nick-names, such as the most recent "Kraken" variant.ĭespite the alphabet soup of variant names, it's important for our COVID-19 tests to continue to detect the virus. It's in their nature to change and adapt to keep themselves alive. Update 2: BinaxNOW Keeps Up with Changing Variants The FDA has also included a full list of all at-home COVID-19 tests that have an EUA and whether they have an extended expiration.
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