The U.S. Food and Drug Administration (F.D.A.) authorized a rapid coronavirus diagnostics test developed by Abbott Laboratories
The antigen test, called BinaxNOW, had previously been authorized by the F.D.A. to be administered by trained healthcare personnel only, but the new clearance will allow patients to test themselves at home, guided by a telehealth app.
The test costs $25 for at-home use. The test it designed to be delivered to patients 15 years or older that suspect they may have contracted the coronavirus. Patients are prompted to collect a viral sample with a nasal swab, which is then inserted into a card that uses a chemical solution to determine whether or not SARS-CoV-2 is present in the sample. Abbott has partnered with the telehealth company eMed to help guide users through the test through an app that ultimately provides the results.
While Abbott's diagnostics test will aid in the ongoing effort to increase broader availability to diagnostics testing, the healthcare prescription will still be a barrier to entry.
On Tuesday, the F.D.A. issued an emergency use authorization (E.U.A.) for the first over-the-counter, fully at-home diagnostics test developed by Ellume which can be used by any individual aged 2 year or older, thus massively broadening testing access.
"By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patients can but it, swab their nose, run the test and find out their results in as little as 20 minutes," said F.D.A. Commissioner Stephen Hahn, according to the Associated Press.
"As we continue to authorize additional tests for home use, we are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options form the comfort and safety of their own homes."
The F.D.A. notes that, in general, antigen tests are not as sensitive as molecular tests, which require laboratory analysis. This means that antigen tests are more likely to show false positives or negatives when compared to molecular tests.
The regulatory agency recommends that those who test positive for SARS-CoV-2 self-isolate and seek additional guidance from their healthcare provider. Individuals who test negative may require additional testing to rule out false negatives, especially if the patient is symptomatic.
The F.D.A. has authorized more than 225 diagnostic tests for COVID-19 since the pandemic began, including over 25 tests that allow for home collection of samples, which are then sent to a lab for testing.