Abbott Labs pushes back on criticism that company's rapid COVID-19 testing is highly inaccurate
John Hackett, vice president of applied research and technology at Abbott Labs, stands behind the tests on 'America's Newsroom.'
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After the Food and Drug Administration said last week that it is investigating preliminary data suggesting Abbott Laboratories' coronavirus tests are inaccurate, a company executive addressed the New York University study that prompted the probe.
“Nearly 1.5 million of these tests have been performed and there are 15 cases that have been reported to Abbott or to the FDA that suggests that the test may have had a false negative value. The NYU study is truly an outlier,” said John Hackett, VP of Applied Research and Technology for Abbott Diagnostics, told “America’s Newsroom.”
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Federal health officials are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the White House.
The FDA said late Thursday it is investigating preliminary data suggesting Abbott Laboratories' 15-minute test can miss COVID-19 cases, falsely clearing patients of infection. The test is used daily at the White House to test President Trump and key members of his staff, including members of the coronavirus task force.
The warning came one day after researchers at NYU reported results suggesting Abbott's test can miss up to half the infections caught by a rival test made by Cepheid. The research has not been peer-reviewed or published in a medical journal and was based on about 100 patients.
Hackett said that the NYU study is fundamentally different from other published observations and the feedback that Abbott labs are receiving from the real world. Hackett described the “real world” as “hundreds of hospitals, doctors offices, urgent care centers, mobile units and municipalities" using the tests.
“Their feedback is 'the test is operating as it should be operating. It’s performing effectively,'” Hackett said.
The researchers found that Abbott's test, run on the company's portable ID NOW system, missed one-third of the infections caught by Cepheid's test when swabs were stored in liquid used to transport laboratory samples. When the samples were kept dry the test missed 48 percent of the cases flagged by Cepheid's test.
The NYU researchers called the test's performance “unacceptable” due to the risk of falsely clearing patients who could spread the infection to others. They acknowledged the shortcomings of the study, including the time needed to transport patient samples to the device for processing.
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Hackett said that Abbott staff discussed the study with the NYU researchers leading them to acknowledge that their study “had limitations” and “was not a well-controlled clinical study.”
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“[NYU] didn’t answer some important questions about when patients were sampled relative to the symptoms. The analysis of their data appears to be highly skewed from a typical distribution than to be observed so that really raises concerns of this study,” Hackett said.
Anchor Sandra Smith pressed Hackett, asking whether he still recommends it for public use.
“Absolutely,” Hackett said.
The Associated Press contributed to this report.
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