Wednesday, April 1, 2020

The Food and Drug Administration approval for testing kit by Bodysphere Inc. result for COVID-19 in 2 minutes.

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.
These antibody tests could help people know if they are able to go back to work, as well as aid researchers in tracking the scale and death rate of the disease — key data for current and future pandemic policies.
They're especially useful for determining whether health care workers have some immunity and are at lower risk if they go back to work.

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.
The big picture: The FDA has been rushing to approve tests from companies that promise quicker results.
Abbott Laboratories received emergency authorization last week to produce portable coronavirus tests, which the company indicates can detect the virus within five minutes.

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