The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

4 years ago
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https://techcrunch.com/2020/03/27/the-fda-just-okayed-multiple-15-minute-blood-tests-to-screen-for-coronavirus-but-there-are-caveats/

On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market.

The tests, which are ‘serological,’ meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).

The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

Mar 27, 2020, 8:42pm UTC
https://techcrunch.com/2020/03/27/the-fda-just-okayed-multiple-15-minute-blood-tests-to-screen-for-coronavirus-but-there-are-caveats/ > On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market. > The tests, which are ‘serological,’ meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).