December 16, 2020
HHS Secretary Azar Statement on EUA for At-Home Use of BinaxNOW Card Test
On Wednesday, the Food and Drug Administration issued a new emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card Home Test, allowing individuals to perform the test at home with a prescription. The test will be offered in partnership with a telehealth service that will guide users step-by-step and report all test results to the relevant public health authorities in accordance with local, state and federal requirements
HHS Secretary Alex Azar issued the following statement:
“FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home. HHS’s testing leadership have worked closely with companies like Abbott for months to accelerate the availability of these exciting new options, part of our commitment to bringing the best of the public and private sectors together to beat COVID-19. We are performing tens of millions of rapid tests per month now, and we are working to ensure this data can be quickly and accurately reported to public health authorities.”
Throughout this fall, HHS has been in the process of distributing 150 million federally purchased Ag Card tests to states and other recipients, and Abbott is currently producing tens of millions of tests per month. The BinaxNOW card test costs $5 and can be read in 15 minutes or less.
The previous EUA for the BinaxNOW card test only allowed for the device to be employed by medical personnel or trained operators in certain non-clinical environments operating through a CLIA certificate.