As the world rushes to create accurate, efficient diagnostics tests to detect the coronavirus, it comes with some worry that the U.S. Food and Drug Administration (FDA) is stating one of these widespread test kits may be inaccurate.
On Thursday, the FDA issued an alert stating that new data put together by researchers from New York University (NYU) may point towards the fact that Abbott Laboratories' rapid ID NOW coronavirus test may be pushing out false results. Specifically, negative results.
The FDA is keeping a very close eye on the matter. "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test."
That said, ID NOW is still able to correctly identify positive results of COVID-19, so it will continue to be used in that regard. If someone, however, receives a negative result back, this has to be cross-checked now.
The FDA's alert was shared a day after the NYU researchers shared their study, which claimed that ID NOW's test missed a third of samples collected with swabs that tested positive with the rival Cepheid coronavirus test.
It's a delicate matter as people with negative test results can carry on with their lives thinking they won't spread the virus when in fact they may well be doing so, and the researchers called the test's performance "unacceptable."
Abbott is rejecting these claims and stating that the researchers are using the test "in ways that it was not designed to be used."
"While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport, and conformity to the way the test was designed to be run," Abbott said in a statement on Thursday. "ID NOW is intended to be used near the patient with a direct swab test method."
There are a number of COVID-19 tests operating around the world, hopefully, they are accurately diagnosing the virus.
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