A box containing a 5-minute test for COVID-19 from Abbott Laboratories is pictured during the daily briefing on the novel coronavirus, COVID-19, in the Rose Garden of the White House in Washington, DC, on March 30, 2020.
Mandel Ngan | AFP | Getty Images
Specifically, the Abbott ID NOW test may return false negative results, the FDA said.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. “We will continue to study the data available and are working with the company to create additional mechanisms for studying the test.”
Despite these concerns, ID NOW may continue to be used to correctly identify positive cases, but negative results may need confirmation from a high-sensitivity authorized molecular test Stenzel said.
Abbott’s share price dropped following the FDA alert, and it is down more than 3% in after-hours trading.
The FDA alert comes a day after researchers at New York University published a study claiming the ID NOW test missed a third of samples collected with nasopharyngeal swabs that tested positive with a test from rival Cepheid.
Abbott Labs refuted the NYU study’s claims that its rapid coronavirus diagnostic test could be missing nearly half of positive cases.
“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,” Abbott said in a statement on Thursday. “ID NOW is intended to be used near the patient with a direct swab test method.”