Schumer calls for ‘crackdown’ on test kits

WASHINGTON, DC — New York Senator Chuck Schumer on April 26 called for the Food and Drug Administration (FDA) to crackdown on COVID-19 virus and antibody testing kits that do not have FDA approval and are being sold online.

Speaking to reporters, Schumer said he was calling on the FDA to increase monitoring of the tests, which he said mostly claim to test for antibodies which determine whether a person has been previously infected by the virus. 

He said “Imagine if it doesn’t work and it’s an antibody test. You get a false positive, and you think you have the antibodies. And you go out on the street, and you get COVID.”

“And if it’s a false negative, you don’t think you have the antibodies, and you do. And you stay home unnecessarily. So there’s no excuse for not having all of the tests approved and authorized by the FDA.”

Schumer said he requested that the FDA publicize which tests have been approved so that members of the public know which tests will be accurate.

FDA Commissioner Stephen Hahn’s said at a press briefing on April 14 that the agency has approved a total of 63 tests for both antibodies and the virus. He said that at the direction of President Donald Trump the FDA was working to remove barriers to the tests getting to the market.

But FDA review of the test was also questioned by the House Oversight Committee, which issued a memo on the topic on April 24, which said, “The FDA did not review any coronavirus rapid antibody test kits before they went on the market, and a lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy.”

The memo further said “FDA is unable to validate the accuracy of antibody tests that are already on the market, and companies are ignoring requests from the Department of Health and Human Services (HHS) to voluntarily submit their tests for validation.”

And it added, “FDA and the Centers for Disease Control and Prevention (CDC) have not put forth standards and guidelines for serological antibody tests, departing from practices governing molecular tests.” 

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