U.S. regulator is reviewing Abbott's fast COVID test after studies raise accuracy concerns

(Reuters) – The U.S. Food and Drug Administration said on Thursday that Abbott Laboratories’ (ABT.N) speedy coronavirus test, which can deliver results within minutes and is used at the White House, could potentially be inaccurate but can still be used to test patients.

The regulator said in a statement that early data about the Abbott ID Now test suggested it could produce potentially inaccurate results, particularly by failing to detect people who have the illness.

It added that it was reviewing data on the test’s accuracy and working with Abbott to find other ways to study the test. Abbott has agreed to conduct multiple studies of the test that will each include at least 150 COVID-19-positive patients in a variety of healthcare settings, the FDA said.

“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, director of the office of in vitro diagnostics and radiological health at the FDA.

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Abbott has distributed more than 1.8 million ID NOW tests.

On Wednesday, New York University researchers said the tests could be missing a third to nearly half of positive cases. The study was not peer reviewed. nL1N2CV2SJ

A study conducted by the Cleveland Clinic in April showed the test detected the virus in around 85% of cases, still lower than some other COVID-19 tests.

“While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use,” the FDA said in its statement.

Abbott has also criticized the studies, saying in a statement on Thursday that the number of patients studied by NYU was small and that some studies had used the test in ways it was not intended to be.

It also said there were other studies that showed a much higher rate of accuracy for its tests, including a study done in a testing clinic in Detroit that said the ID NOW test was accurate 98% of the time.

“The availability and ease-of-access of ID NOW, which delivers results in minutes rather than a day or more, is helping to reduce the risk of infection in society by detecting more positive results than would otherwise be found,” Abbott said in a statement.