FDA to Investigate False Negative Reports Related to Abbott’s Rapid COVID-19 Test


Following a study that raises concerns about the accuracy of Abbotts rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration (FDA) announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.

This week, a study conducted by NYU Langone Health in New York City found that the Abbott system, which is used by multiple government agencies including the White House, missed 48% of positive cases that were revealed through a separate clinical test. The study, which has not been peer reviewed, pitted the Abbott ID NOW test against Cepheid’s GeneXpert, which takes about 45 minutes to complete a test.

Within hours of the study results being made public, the FDA said it will investigate the accuracy of the Abbott test concerning false negatives. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said the regulatory agency is studying the study data and is working with Abbott to create additional mechanisms for studying the test. He added that the FDA and Abbott are working on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another 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,” Stenzel said in a statement.

Illinois-based Abbott, which received Emergency Use Authorization for the ID NOW test in March, has defended its product and speculated that user error is to blame for the plethora of false negatives in the NYU study.

“We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. 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%,” Abbott said in a statement.

Abbott added that results from the test depend on numerous factors, including “patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run.” The company said ID NOW is designed to be used near a patient who was tested with a direct swab method. Abbott has previously warned against storing swab specimens in a preservative before testing. The company said this could hamper accuracy. Since the ID NOW system received EUA, the Abbott said more than 1.8 million ID NOW tests have been distributed and the reported rate of false negatives to the company has been 0.02%. Abbott said it is reinforcing proper sample collection and handling instructions.

In its own announcement, the FDA said its investigation will look into how the samples were collected to determine if that was a factor in the outcome. Also, the regulatory agency said that some studies assessing the efficacy of tests like ID NOW have limitations that should be taken into account, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use.

Abbott noted that as more information is learned about COVID-19, it will incorporate those new findings into its diagnostics devices. The company said it will continue to clarify its product information in order to provide better guidance to healthcare providers that “negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.” Abbott added that negative results should be presumed negative, but if they remain inconsistent with clinical signs and symptoms, then a patient should be tested with an alternative molecular assay.

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