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Abbott's rapid coronavirus test misses nearly half of positive cases, study finds | TheHill
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The analysis of Abbott's ID NOW system, which has not been peer-reviewed, found the test to be "unacceptable" in a clinical setting.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.
"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 Trump. 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.
