FDA Warns About COVID-19 Test That Could Provide False-Positive Results

The U.S. Food and Drug Administration is warning that a coronavirus diagnostic test made by Becton, Dickinson and Companycould provide false-positive results.

One study by the manufacturer found the test had roughly 3% false-positive results, the FDA said.

A negative result, the drug watchdog warned, doesn't rule out the possibility that the patient has COVID-19.

The FDA gave emergency use authorization to Becton’s BD SARS-CoV-2 Reagents for the BD Max System on April 8.

The test uses a nasal swab to detect viral nucleic acid that causes COVID-19 in the upper respiratory system.

As part of its advisory, the FDA recommended medical professionals consider confirming the results with an alternative authorized test.

The FDA said it is working with Becton to resolve the testing proboem . Adverse effects are encouraged to be reported to the agency.

Shares of Becton were trading at $249.73 as of 10:27 a.m. ET, down $0.74 or 0.30%