FDA authorizes 15-minute coronavirus test
By Arman Azad
(CNN) Federal health officials on Friday approved a coronavirus test that can provide results in less than 15 minutes, using the same technology that powers some rapid flu tests.
Teased by Vice President Mike Pence in a Thursday press briefing, the new diagnostic test could accelerate testing in the United States, allowing for rapid results in doctors’ offices. But shortages of critical equipment used to collect patient specimens, like masks and swabs, could blunt its impact.
The US Food and Drug Administration authorized the test for emergency use, signaling that federal regulators were satisfied with the test’s validation data and believe its benefits outweigh any risks, such as false positives or negatives.
The test’s maker, Abbott Laboratories, said it expects to deliver 50,000 tests per day beginning next week. The technology behind the test looks for genes that are present in the virus, similar to PCR (polymerase chain reaction) tests already on the market.
The platform used to run the test weighs less than 7 pounds, according to Abbott, and could be deployed “where testing is needed most.”
Last week, the FDA authorized another rapid test from molecular diagnostics company Cepheid, which provides results in about 45 minutes. Most laboratory tests for the coronavirus take anywhere from a few hours to days to receive results.
A new COVID-19 test can return results in 5 minutes
It can run at urgent care clinics and doctors’ offices
A new COVID-19 test from the medical device company Abbott can return positive results in five minutes — and it can be run in a doctor’s office. The test was approved for emergency use in the United States by the Food and Drug Administration last night.
The test uses Abbott’s small, portable ID NOW platform, and doesn’t have to be sent to a central lab for analysis. Instead, it can be done directly in an emergency room or urgent care clinic, which could cut down on the days-long wait time some patients now face for test results. Doctors could take a swab from a patient’s nose or throat and insert it directly into the machine, and have results within 15 minutes (it can take up to 13 minutes if the sample is negative for the virus).
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“We project that roughly 56 percent of our population – 25.5 million people – will be infected with the virus over an eight week period,” Governor Newsom of California wrote on 3/19/2020.