Sen. Chuck Schumer on Sunday called on the U.S. Food and Drug Administration to crack down on unproven at-home coronavirus tests that he said are proliferating online.
The do-it-yourself tests in question — both for the virus and the antibodies against it — have not been authorized by the FDA, Schumer said, and inaccurate results could put users in danger.
"Imagine if it doesn't work: you get a false positive and you think you have the antibodies, you go out on the street and you could get COVID," Schumer said at a news conference in Manhattan. "There's no excuse for not having all of the tests approved and authorized by the FDA."
Schumer asked the federal agency to increase policing of the online market for at-home tests, let the public know which have been approved and send cease-and-desist orders including threats of large fines to companies selling any without FDA approval.
"Too many of the testing kits that are sold online are unproven, untested, unregulated," Schumer said. "That has to change."
Asked for comment Sunday on the senator's request, FDA spokeswoman Stephanie Caccomo referred to administration Commissioner Stephen M. Hahn's remarks at a White House news conference on Friday.
"What we've told manufacturers is that, in order to market in the U.S., they have to validate their tests, they have to tell us that they validated their tests and, in the package insert, they have to let people know — and users, labs, et cetera — that those tests were not authorized by FDA," Hahn said.
Hahn said the agency last week OK'd the first at-home diagnostic test for the virus, made by North Carolina company LabCorp. He said the FDA has also approved four antibody tests.
Caccomo did not respond to a question about whether any of those four antibody tests could be administered at home.
Hahn's remarks followed the release Friday of a memo prepared by staffers of a U.S. House subcommittee that said many companies are selling "fraudulent" coronavirus antibody tests and the FDA has "failed to police the coronavirus serological antibody test market."
One set of unauthorized antibody tests sold online ended up in the hands of Ashley Allen and her family in Commack.
Allen said she and her mother, father and brother-in-law took the blood tests last week, but they were dismayed to see a note included in the package that stated "these antibody tests are not FDA approved" and "negative results do not rule out COVID-19 infection."
Allen declined to say what company sold them the tests or how much they cost.
The family's results all came back negative for the antibodies, Allen said, but she's skeptical of the tests' accuracy.
"It kind of gives you a false hope that you can figure out what's wrong with you or figure out if you've been exposed," said Allen, 31. "It kind of leaves you with a lot of questions."