HealthDay Reports: FDA Goes After Unproven COVID-19 Antibody Tests
Manufacturers have been putting COVID-19 antibody tests on the market since mid-March, but today the U.S. Food and Drug Administration (FDA) said it's cracking down to help ensure these tests are accurate.
MONDAY, May 4, 2020 (HealthDay News) -- The U.S. Food and Drug Administration said Monday it will crack down on the fraudulent COVID-19 antibody tests that have flooded the market.
Companies selling coronavirus antibody tests will be required to submit data proving accuracy within the next 10 days, or their products could be yanked from public circulation, FDA officials said.
Since mid-March, dozens of manufacturers have been allowed to sell antibody tests without providing any evidence they are accurate, under the initial policy announced by the FDA.
The intent of the initial policy was to support "the availability of antibody tests, which are an important tool in our fight against the coronavirus," FDA Commissioner Dr. Stephen Hahn explained during a media briefing.
Unfortunately, many of the tests that came onto the market simply aren't accurate.
A recent assessment of 14 coronavirus antibody tests now available to consumers revealed that only three delivered consistently reliable results, according a report issued by a team of more than 50 scientists.