FDA grants emergency approval for 15-minute corona
The U.S. Food and Drug Administration has authorized the emergency use of a new
The U.S. Food and Drug Administration has authorized the emergency use of a new rapid coronavirus test that could give patients results in less than 15 minutes.
Abbott, the medical device company that created the test, said Friday that it can deliver "results in as little as five minutes and negative results in 13 minutes."
Other approved tests are able to provide results within hours or days.
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.
More than 110 laboratories are already doing COVID-19 tests under FDA policies and guidelines, the agency said.
Abbott said it is ramping up production to deliver 50,000 tests to the U.S. health care system starting next week.
"Testing remains a crucial step in controlling the novel COVID-19 pandemic. Continuing to supply healthcare providers with new technologies to help curb the spread of infection is a top priority for public health officials and healthcare providers," the company said in a statement.
Source : aol.com/news