FDA authorizes 2-minute test kit for COVID-19 antibodies

FDA authorizes 2-minute test kit for COVID-19 antibodies

[Ed. – Very good news, although it won’t detect the infection before the antibodies develop. That limits the utility as a precautionary measure, but most people being tested are symptomatic already, as I understand it.]

The Food and Drug Administration issued an emergency approval Tuesday for a serological testing kit produced by Bodysphere Inc. that can detect a positive or negative result for COVID-19 in two minutes.

Why it matters: Access to testing has improved in the U.S. thanks to commercial labs, but the average wait time for a patient’s results is four to five days — with some reports of it taking more than a week.


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Yes, but: The Bodysphere two-minute test can only detect the coronavirus in people who have had the infection for several days, meaning the test can’t be used too early on when the body hasn’t produced enough antibodies.

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