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FDA Warns Abbott's Coronavirus Rapid Test Kits Used By White House Possibly Shows False Negative

May 15, 2020 6:06 am
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FDA Warns Abbott's Coronavirus Rapid Test Kits Used By White House Possibly Shows False Negative

The Food and Drug Administration (FDA) on Thursday warned that rapid novel coronavirus (COVID-19) testing kits developed by Abbott Laboratories (NYSE:ABT) are frequently returning false negatives, according to preliminary data.

What Happened

The regulatory agency said it continues to evaluate the information and work with Abbott, but warned citizens of false hopes from getting a negative result for COVID-19.

"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," Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, Tim Stenzel, said 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," he added.

The FDA said it received 15 "adverse event reports" about the Abbott ID Now device used for COVID-19 testing, suggesting some of the results were inaccurately negative.

The agency is investigating the cause of the false negatives, including whether they could be caused by the types of swabs used for taking samples, or the material used to transport the specimen, the statement noted.

Abbott will conduct post-market clinical trials involving at least 150 COVID-19 patients to further assess the accuracy, according to the FDA.

Why It Matters

President Donald Trump had recently said that Abbott's ID Now point-of-care devices were used to screen him and other officials at the White House for coronavirus.

A study at the New York University concluded that Abbott's test missed 48% of COVID-19 positive cases that were detected by a rival company's testing kits, Washington Post reported.

Former FDA Commissioner Scott Gottlieb similarly warned about accuracy of Abbott's tests in an interview with CBS News, but dubbed the antigen test, like the one developed by Quidel Corporation (NASDAQ: QDEL) as a "real game changer."

Price Action

Abbott shares closed 0.4% lower at $91.79 on Thursday and slipped another 3.6% in the after-hours session at $88.50.

Image Credit: Abbott.com

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