Abbott rapid COVID-19 test may yield false negatives, FDA warns

Abbott defended the test, which the FDA said can still be used: “While no test is perfect, Abbott’s ID NOW is delivering reliable results when and where they’re needed most.”

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White House Coronavirus Task Force Holds Daily Briefing

President Donald Trump holds a new COVID-19 test kit developed by Abbott Labs during the daily coronavirus briefing at White House in late March.

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The federal Food and Drug Administration issued a warning Thursday night that early data suggests Abbott Laboratories’ rapid coronavirus test, touted by the Trump administration as a game changer, may return inaccurate and false negative results — findings the Chicago-area firm vehemently denied.

The Abbott ID NOW test — which can provide results in minutes — is used by the White House to quickly test anyone who comes into proximity of President Donald Trump. Trump has lavished attention on the Abbott ID NOW test and featured it at a White House event three days after the FDA fast-tracked its approval by granting an emergency use authorization on March 27.

In just a few weeks time, Abbott has shipped 1.8 million of the ID NOW tests, which is used at several Chicago-area testing sites.

The FDA warning came a day after a New York University preliminary study raised questions about its accuracy. The study was not subject to peer review, a process that checks on the procedures used for a study as well as its findings.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said 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. 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.”

Abbott: Study flawed

Abbott, headquartered in Lake County near North Chicago, said the NYU study is flawed.

“We’re seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used,” the company said in a statement. “In particular, the NYU study results are not consistent with other studies. While we’ve seen a few studies with sensitivity performance percentages in the 80s, we’ve also seen other studies with sensitivity at or above 90%, and one as high as 94%.

“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. ID NOW is intended to be used near the patient with a direct swab test method,” Abbott said.

That test compared findings between two systems: the Abbott ID NOW and the Cepheid Xpert Xpress. The samples were obtained from 101 patients with COVID-19 symptoms seeking treatment at New York University’s Langone Tisch Hospital.

In using one kind of nasal swab and liquid to store the sample, the “Abbot ID NOW COVID-19 missed a third of the samples detected positive by Cepheid Xpert Xpress” with the rate going to 48% using a different type of nasal swab, the study found.

Though the FDA acknowledged it was aware of some studies that have raised concern over the accuracy of Abbott’s device, the agency said in the statement it “is investigating whether it could be due to the types of swabs used or the type of viral transport media.”

Rapid testing is seen as key to easing stay-at-home orders and Abbott’s ID NOW was one of the first on the market.

Some inaccurate negative results

The Abbott ID NOW system also has the advantage that the machine used to analyze samples is about the size of a toaster and can be used anywhere.

Abbott and the FDA are currently working to analyze the information that has been gathered and to alert users that any negative results that aren’t consistent with a patient’s symptoms or signs should be confirmed with another test.

The FDA is now reviewing 15 “adverse reports” about the device which “suggest some users are receiving inaccurate negative results.” Abbott has also agreed to conduct post-market studies of the device that will include at least 150 COVID-19 patients in various clinical settings.

The FDA granted Abbott emergency use authorization — known as EUA — for the test on March 27. Abbott said in a release when the ID NOW went on the market, the “ID NOW COVID-19 rapid point-of-care test can provide test results in 13 minutes or less. Early detection can accelerate care, reduce viral spread and help people get on the road to recovery sooner.”

Physician here had doubts

At least one local physician has been hesitant to use the scrutinized Abbott test even before the new study.

When Dr. Rahul Khare started offering coronavirus testing at his clinic in Lincoln Park, he opted to use polymerase chain reaction tests that he sends to an outside lab for processing. Though it takes about three days to get results back, Khare didn’t even consider using the speedier Abbott test

“I’m very particular about the tests I use and I know the technology of that test because it’s the same technology that I’ve used for Abbott rapid flu and strep [tests]. And I just know they’re not very good for a variety of reasons,” said Khare, founder of Innovative Express Care.

“It’s a very specific thing that happens: When you use a DNA amplifier, the problem is if you don’t get an adequate amount of the specimen, it makes it invalid. And on top of that, I know that that’s just not as best of a technology as PCR.”

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