Story at a glance
- The Abbott test revealed multiple false negatives in a New York University study.
- The company notes that this analysis does not track with other documented reports.
A preliminary report from researchers at New York University (NYU) calls the results of the Abbott ID NOW COVID-19 test — the assessment currently used by the White House — into question, though the company disputes those findings.
The study compared the Abbott test to another real-time RT-PCR platform, the Cepheid Xpert Xpress SARS-CoV-2. The Cepheid test can return results in about 45 minutes, while the Abbott test runs in as little as five minutes.
Researchers found that the Abbott test missed about a third, or 33 percent, of the samples detected positive by the Cepheid Xpert assay using a nasopharyngeal (NP) swab specimen.
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When using the currently recommended dry nasal swab, the Abbott test missed more than 48 percent of positive samples.
The authors of the report used 101 dry nasal samples and 101 NP samples from the same Emergency Department patients to be tested using both the Abbott and Cepheid tests.
While initial results of the Abbott NOW test showed that it performed well when testing samples with low CT values, or high amounts of nucleic acid, but did not capture all positive results for samples with lower amounts of nucleic acid, or high CT values.
Some 31 of the 101 patients tested positive for the coronavirus by the Cepheid Xpress test. When using Abbott, 48 percent of those patients received false negative results.
In the discussion of the study, researchers say that given the urgency of the pandemic, accurate diagnostic testing is “crucial to mitigating continued infectious transmission.”
Other studies at Northwell Health and the Cleveland Clinic also point to a lower sensitivity threshold for the Abbott test.
The NYU study has yet to be peer reviewed, and the study’s relatively small sample size and inability to control for confounding variables are some of the limitations. The authors note, however, that the fact that the Abbott test “misses positive samples on patients being admitted to the hospital with clinical picture of COVID19 makes this technology unacceptable in our clinical setting.”
According to Bloomberg, the Abbott test is the primary test used at the White House. In late March, President Trump stood before the press in the White House Rose Garden, describing the test as “a whole new ballgame.”
On May 13, Abbott issued a statement in reply to the NYU study, defending its product by stating that the NYU study is not consistent with other studies, citing one in Washington state that demonstrated a higher 91 percent sensitivity reading.
“While no test is perfect, Abbott’s ID NOW is delivering reliable results when and where they’re needed most. The test is performing as expected by the more than 1,000+ sites using ID NOW for COVID-19,” the company concluded, adding that they were currently unsure if the researchers ran the tests correctly.
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