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FDA issues warning on accuracy of Abbott's rapid coronavirus test after study finds false negatives

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Key Points
  • The U.S. Food and Drug Administration issued an alert on Thursday saying there is early data that suggests  Abbott Labs' rapid coronavirus diagnostic test for Covid-19 may be delivering inaccurate results. 
  • Specifically, the Abbott ID NOW test may return false negative results, the FDA said. 
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

The U.S. Food and Drug Administration issued an alert Thursday about the accuracy of Abbott Labs' rapid Covid-19 test after researchers at New York University said it was missing a third to almost half of the positive cases.

The FDA said the Abbott ID NOW test, which is used to screen White House staff, may return false negative results. 

"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."

The study, which has not been peer-reviewed, found Abbott's ID NOW test missed a third of samples collected with nasopharyngeal swabs that tested positive with a test from rival Cepheid. When using samples collected with "dry nasal swabs," the Abbott test missed more than 48% of positive cases, the study said. Both nasopharyngeal swabs and dry nasal swabs are collected from the nostril, but the former is inserted much deeper into the nose.

Stenzel said 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. 

Abbott's shares were down by about 2.6% in premarket trading Friday. 

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."

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.
FDA issues warning on accuracy of Abbott's rapid coronavirus test after study finds false negatives