Abbott Virus Test Used at White House Faces Accuracy Concern
Date: 2020-05-15 16:21:55
The coronavirus test from Abbott Laboratories used at the White House to get rapid answers to whether someone is infected may miss as many as half of positive cases, according to a report from New York University that the company immediately disputed.
The analysis, which has yet to be confirmed, found that Abbott’s ID NOW missed at least one-third of positive cases detected with a rival test and as much as 48% when using the currently recommended dry nasal swabs, according to the report on BioRxiv, a server where researchers post early work before it has been reviewed by other scientists.
Abbott said the researchers didn’t use the test as intended and that the false-negative rate, as reported to the company, is 0.02%.
Shares of the company fell 1.8% to $92.16 in New York on Wednesday. They are up 6.1% this year.
The White House is frequently testing staff, governors, lawmakers, reporters and others who come in close contact with the president using ID Now. The testing machine, which is roughly the size of a toaster, is portable and doesn’t require deep nasal swabs, about which President Donald Trump once said there is “nothing pleasant.”
Trump touted the Abbott machine with great fanfare in the White House Rose Garden after the Food and Drug Administration approved it for emergency use, saying it could be a godsend for hospitals and workplaces because it “delivers lightning-fast results in as little as five minutes.”
“That’s a whole new ballgame,” the president said at the March 30 event.
The White House declined to comment on the study, referring questions to the Food and Drug Administration. The agency is “reviewing the information in this non-peer-reviewed study,” a spokeswoman said Wednesday.
The results of the NYU study, if confirmed, indicate the test may still suffer from high false-negative rates despite changes recommended by the company to avoid such a problem. In April, after other academic researchers raised concerns about the issue, Abbott told clinicians to avoid storing samples in so-called transport media, a liquid used to hold the sample, as that might dilute the test and lead to false negatives.
But when the NYU authors attempted to account for changes and avoid false negatives by using dry swabs, the performance was even worse. It missed the virus in 48% of the samples that were positive using Cepheid GeneXpert, a standard reference test sold by Danaher Corp. The NYU study hasn’t yet been reviewed by outside experts or published in a scientific journal.
Abbott said its scientists are still reviewing the 12-page paper. It has distributed about 1.8 million ID NOW tests and said it hasn’t found the problem identified by the NYU report.
“It’s unclear if the samples were tested correctly, and we’re further evaluating the results,” said Darcy Ross, an Abbott spokeswoman. “The test is performing as expected when it’s used correctly.”
The researchers, who tracked infections among 101 patients treated in the emergency department at NYU Langone Tisch Hospital, said they stand by their findings and the conclusion that the technology is unacceptable for use in a clinical setting.
They also acknowledged the limitations of the study in a statement, including its small size and the testing of the samples in a laboratory rather than at the point of care. They declined interview requests.
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