FDA warning over false-negative results with Curative’s COVID-19 test

HOUSTON – The Food and Drug Administration is warning about the risk of false results, specifically false negatives, with Curative’s COVID-19 test.

The agency posted an alert to patients and healthcare providers on its website on Monday.

“The dangers of the false-negative are multifold,” said Joe Petrosino, a professor and chair of molecular virology and microbiology at Baylor College of Medicine. “There’s people who are at risk for severe disease who would think that they’re ok but in actuality had the disease.”

The company lists more than a half-dozen testing locations in the Houston area, including one near Minute Maid Park. It’s also one of the Houston Health Department’s testing partners.

According to Curative’s website, the test involves coughing three to five times and then swabbing the inside of your mouth.

The FDA said the test needs to be done properly, under the watch of a trained healthcare worker, to reduce the risk of the wrong result.

“When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate,” the agency wrote.

“People are taking these tests sometimes in their cars, people are monitoring through a window, but sometimes you can’t necessarily see every step of the process that’s involved and that could be having an impact on the result as well,” Petrosino said.