FDA has provided emergency use authorization for Abbott’s easy-to-use COVID-19 antigen test
The U.S. Food and Drug Administration issued Emergency Use Authorisation (EUA) for BinaxNOW COVID-19 Ag Card rapid test to detect the COVID-19 infection. The product will be available at $5. Abbott has announced the results will be available in 15 minutes, the test is similar to the pregnancy test.
Abbott has announced that BinaxNOW uses later flow technology, whose efficacy was proven and expected to provide reliable results. There is no need for any other device, and Abbott claims that it helps in quick detection.
Abbott will launch a mobile application called NAVICA for Android and iPhones; the application will display a digital pass for people who tested negative. Further, the company claimed that this helps the organizations to facilitate the entry of employees.
In the data submitted by Abbott to the U.S. Food and Drug Administration, the device has shown 97.1% sensitivity (positive percentage agreement) and 98.5% (negative percentage agreement) in patients within the first week who had symptoms.
How does the device work?
A healthcare provider collects the sample from the nose using a swab, adds the sample to the card along with the testing reagent. After 15 minutes, results will be visible; one line indicated COVID negative, and two lines indicated COVID positive result.
The FDA has allowed the use of the device at doctor’s office, emergency room or school.
From October 2020, Abbott announced that it is planning to make up 50 million kits available in the U.S.
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