FDA Cracks Down On Antibody Tests For Coronavirus

( By Richard Harris for NPR)

The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus.

These tests are designed to identify people who have been previously exposed to the virus. The FDA said more than 250 developers have been bringing products to the market in the past few weeks.

In a rush to make antibody tests available as quickly as possible, the FDA had set a low standard for these tests. Manufacturers were supposed to submit their own information about the accuracy of their wares, but the agency had no standards for what would be acceptable. Companies weren’t allowed to claim the tests were authorized by the FDA, under initial guidance issued in mid-March.  Continue reading article here…

Notice: The link provided above connects readers to the full content of the posted article. The URL (internet address) for this link is valid on the posted date; medicarereport.org cannot guarantee the duration of the link’s validity. Also, the opinions expressed in these postings are the viewpoints of the original source and are not explicitly endorsed by AMAC, Inc.; the AMAC Foundation, Inc.; or medicarereport.org.