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Abbott's rapid coronavirus test misses nearly half of positive cases, study finds

Abbott's rapid coronavirus test misses nearly half of positive cases, study finds
© getty: A box containing a 5-minute test for COVID-19 from Abbott Laboratories

A rapid coronavirus diagnostic test manufactured by Abbott may miss nearly half of all positive infections, according to a pre-published study from New York University.

The analysis of Abbott's ID NOW system, which has not been peer-reviewed, found the test to be "unacceptable" in a clinical setting.

But Abbott said it's not clear if the researchers used the samples correctly. A spokesperson said the company's own rate of false negatives that it has shared with the Food and Drug Administration (FDA) is .02 percent. 

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"In communications with the users of the test, it is performing as expected," Darcy Ross said in a statement to The Hill. "ID NOW is an important tool that delivers information where it’s needed most — taking the fight to the frontlines so that public health officials and healthcare providers can make critical decisions." 

The researchers said the NYU labs use tests that take too long to diagnose a patient with COVID-19 and they were searching for a quicker method. According to the company, the Abbott ID NOW test can produce positive results within 5 to 13 minutes and negative results within 13 minutes.

The ID NOW system is a point of care test, meaning it can be conducted in a hospital or other health facility without shipping the result back to a central lab.

The test is notably used by the White House on administration officials and other people who might come into close contact with President TrumpDonald John TrumpFox News president, top anchors advised to quarantine after coronavirus exposure: report Six notable moments from Trump and Biden's '60 Minutes' interviews Biden on attacks on mental fitness: Trump thought '9/11 attack was 7/11 attack' MORE. Trump spoke highly of the test when it was granted emergency use authorization by the FDA in March, and offered to send some of the machines to the Capitol to test lawmakers. 

The analysis found Abbott's test missed a third of samples collected with nasopharyngeal swabs, which are taken from the back of the nose, that tested positive with a rival test from Cepheid. 

When using samples collected with “dry" nasal swabs, Abbott test missed more than 48 percent of positive cases, the study said. The "dry" swabs do not go as deep into the nose and are what the company recommends for the test. 

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This is not the first time that the accuracy of the ID NOW system has been called into question.

In April, other researchers found the test had a high rate of false negatives, leading Abbott to issue labs a clarification to say they should not store samples in "viral transport media" before being tested to avoid the risk of dilution. 

The NYU study is in pre publication, meaning it has not been peer-reviewed or accepted into any medical journal. 

The study researchers noted the urgency to ramp up coronavirus testing “has eased the usual scrutiny” applied by FDA.

The agency has granted emergency use authorizations for multiple tests, including Abbott’s. The authorization is less rigorous than a normal approval, and is meant to review evidence while the product is on the market.