COVID-19 tests cleared for US sale without FDA review raise safety concerns

The FDA has allowed more than 90 antibody tests on the market without prior review, leaving experts concerned about the quality of the tests, The Washington Post reported. 

Antibody tests are those that detect the body's immune response to an infection and can help public health experts identify people who have recovered from COVID-19, including those that never showed symptoms. 

The FDA has only granted emergency use authorization to four antibody tests from Cellex, Chembio Diagnostic Systems, Ortho Clinical Diagnostics and Mount Sinai Laboratory as of April 20. But the agency has allowed more than 90 tests to be marketed without FDA review. 

In mid-March, the agency said manufacturers can sell antibody tests after validating results themselves and simply notifying the agency of their plans to sell, the Post reported. The goal was to ensure quick access to antibody tests, which public health experts say play a pivotal role in reopening the economy. 

The tests are required to have a label saying they aren't FDA approved or meant to be used as the sole basis for diagnosing COVID-19 infection. 

The dozens of tests on the market without FDA review could confuse physicians, hospitals, employers and consumers and lead people to falsely believe they are safe to end social- distancing rules, according to the Post

"Having many inaccurate tests is worse than having no tests at all," Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories, told the Post 

FDA Commissioner Stephen Hahn told the Post that "people should be very cautious" about tests that have not been FDA reviewed or received emergency use authorizations. 

Even with high-quality tests, scientists still don't have enough data on COVID-19 antibodies to determine if they give immunity against reinfection. 

The FDA is expected to give emergency use authorization to more antibody tests in the coming weeks, the Post reported. 

Read the full article here.

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars