LA Will Continue to Use Coronavirus Test Flagged by FDA

MONDAY, Jan. 11, 2021 (HealthDay News) -- A coronavirus test that may sometimes give false results will continue to be used in Los Angeles, while Congress will instead turn to a different test.

Last week, the U.S. Food and Drug Administration said the test from California company Curative could produce false negatives, leading people with the virus to unknowingly spread it, the Associated Press reported.

The test is used by at least three of the largest U.S. cities, the AP reported.

The FDA action came after the company tried to expand testing beyond what it was originally approved for, which was in people with symptoms such as fever, sore throat and fatigue, or those exposed to the virus, Dr. Jeffrey Klausner, Curative's acting medical director, told the AP.

The company submitted research to support authorization to test individuals without symptoms or exposure to the virus who could self-administer the test without supervision.

"The answer is it works pretty well, but not well enough that it gave the FDA confidence to expand ... authorization to that population," Klausner said.

He didn't provide numbers on the test's efficacy to the AP, but said it didn't pick up the virus in the later stages in asymptomatic people. He said the FDA's action was a reminder to stick to the intended purpose of the test it approved.

Still, Los Angeles Mayor Eric Garcetti said he continues to back the Curative test, the AP reported.

MedicalNews
Copyright © 2020 HealthDay. All rights reserved.

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW