America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test

While many coronavirus tests provide results within hours or days,
America’s Food and Drug Administration “has authorized the
emergency use” of a new rapid coronavirus test from medical device
manufacturer Abbott that could results in less than 15 minutes,
reports NBC News: The FDA told Abbott it authorized the test’s use
after determining that “it is reasonable to believe that your
product may be effective in diagnosing COVID-19,” based on the
scientific evidence presented. The agency added that the “known and
potential benefits” of the test outweigh potential risks, such as
false positives or negatives. The technology being used for the new
test is similar to the one found in rapid flu tests, according to
the FDA’s authorization letter and Abbott. The FDA also said Friday
it has issued at least 19 other emergency use authorizations for
diagnostic tests to detect COVID-19, and that it is working with
more than 220 test developers who are expected to submit
emergency-use authorization requests soon… Abbott said it is
ramping up production to deliver 50,000 tests to the U.S. health
care system starting next week.


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Source: *FS – All – Science News 2 Net
America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test