President Trump examined Abbott’s device at the White House on March 30.
Photo: Agence France-Presse/Getty ImageResearchers reported a device manufactured by Abbott Laboratories widely used to swiftly detect coronavirus, including among senior White House officials, missed nearly half of the positive cases detected by another common test.
The researchers at NYU Langone Health in New York City compared the Abbott ID Now to another device, finding that it missed 48% of positive cases the other machine detected. The NYU study hasn’t been peer-reviewed and was posted online Tuesday ahead of formal publication.
Medical experts say what are known as false negatives could lead people infected with the virus to unknowingly spread the virus. At the White House, where President Trump, Vice President Pence and other senior officials are regularly tested using the device, that risk was highlighted when two aides tested positive last week.
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The Abbott device can produce test results in less than 15 minutes. That fast turnaround attracted attention from President Trump and other officials as testing backlogs swelled in March.
Abbott said “it is unclear if the samples were tested correctly in this study.” The company said it has distributed about 1.8 million ID Now tests, and the reported rate of false negatives to Abbott is 0.02%.
The company said the NYU results weren’t consistent with other studies of the test, such as one conducted by city officials in Detroit that found the ID Now correctly detected 48 out of 49 positive samples.
In a written statement, NYU said the health system’s director of clinical laboratories, Maria Aguero-Rosenfeld, led the study in an effort to find a faster testing device to reduce emergency-room wait times for testing.
“The authors acknowledge the limitations of the study, which include a relatively small sample size and testing of the nasal swabs in the laboratory rather than at the point of care,” the statement said.
The study involved 101 emergency-room patients who were referred for testing at the hospital during a three-day period. For each patient, two swabs were taken. One swab was tested using a device the NYU lab had already validated, Cepheid’s GeneXpert, which takes about 45 minutes to complete a test. The other swab was taken using Abbott’s recommended method and tested in the ID Now.
The GeneXpert detected 31 positive cases among those samples. By contrast, the Abbott device detected only 16 out of the 31. “The remaining 15 samples were falsely negative,” the authors reported in the study.
In another portion of the study, the authors examined 15 positive specimens that had been stored in a liquid on both devices, finding that the ID Now missed one-third of those cases. Last month, Abbott changed the ID Now’s instructions to warn against using the preservative, which it said had contributed to earlier concerns about test accuracy.
An FDA spokeswoman said, “We’re reviewing the information from the non-peer-reviewed study.”
In April, The Wall Street Journal reported that several lab directors said the Abbott ID Now was producing false negative results using samples stored in the preservative as much as 25% of the time.
The White House has continued to rely on the testing platform, which it first obtained in March, to conduct daily testing of the president, the vice president and anyone who is in close proximity to them, aides said. The White House has also used the Abbott test on reporters who come close to the president or who were exposed to a White House official who later tested positive for Covid-19, the disease caused by the new coronavirus.
The White House declined to comment.
Last week, Katie Miller, the vice president’s press secretary, tested positive for the virus. The president’s personal valet also tested positive.
Mr. Pence’s spokesman said he isn’t self-isolating, but White House press secretary Kayleigh McEnany said Tuesday that the vice president was keeping his distance from President Trump.
In recent days, Mr. Trump and top administration officials have continued to praise the Abbott device. “These tests are highly sophisticated—very quick, very good,” he said on May 11. “We do have a great testing capability at the White House.”
Adm. Brett Giroir, the administration’s testing coordinator, said at the May 11 briefing that the administration had deployed more than 235,000 Abbott tests to state public-health laboratories.
Write to Christopher Weaver at christopher.weaver@wsj.com and Rebecca Ballhaus at Rebecca.Ballhaus@wsj.com
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