FDA informs public about possible accuracy concerns with Abbott ID NOW; Abbott responds

May 16, 2020

The U.S. Food and Drug Administration (FDA) issued a public alert about early data suggesting that the Abbott ID NOW point-of-care (POC) test to diagnose COVID-19 may return false negative results, the agency said in a news release.

Abbott’s ID NOW test, which has received emergency use authorization (EUA) from the FDA, is in use at healthcare organizations around the country.

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

Among the data suggesting false negative results was a preprint paper released this week by researchers at New York Langone Health comparing Abbott’s ID Now test with another POC test with FDA EUA: Cepheid Xpert Xpress SARS-CoV-2. The researchers used nasopharyngeal swabs transported in universal transport media (VTM), as well as dry swabs for the Abbott test.

In the study, which has not been peer reviewed, researchers said the Abbott test missed one-third of the samples that tested positive in the Cepheid test using NP swabs in VTM and it missed 48 percent of positive results with the dry swabs. A total of 101 emergency room patients were swabbed twice and were included in the study.

However, Abbott officials disputed those findings in a press statement. “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,” the company said. “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.”

In addition to research papers, the FDA said it “has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency is reviewing these reports. It’s important to note that the adverse event reports the FDA receives from manufacturers, health care providers, health care facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.”

The FDA also said that Abbott has agreed to conduct post-market studies for the ID NOW test. Each study will include at least 150 patients from a in a variety of clinical settings who have tested positive for COVID-19. The agency said the studies would help the FDA “understand the cause or patterns of any accuracy issues and inform any additional actions the company or the FDA should take.”

Abbott said it planned to clarify with its customers that negative results “should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay.”

Abbott also said it is reiterating with customers instructions about how to collect and handle samples properly.

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