NEW YORK (CBSNewYork) — Days after the Food and Drug Administration approved the first at-home coronavirus testing kit, there’s concern that an increasing number of tests are being sold online and misleading consumers.
Some claim they can detect the virus. Others claim they can detect antibodies. But none of them may be accurate, CBS2’s Lisa Rozner reported Sunday.
Commack clothing store Tandywear has transformed into a mask-selling business, but before Ashley Allen went in to help her mom, the owner, she wanted to get an antibody test and found one online. By phone, she told Rozner it required she prick her finger at home.
“When there’s a line next to the C, that means your negative,” Allen said.
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But after seeing the disclaimer it wasn’t FDA approved, she questioned its accuracy. So-called “rapid” tests claim to provide results within minutes, but certain ones are being marketed to doctors and consumers online. Microbiologist Dr. Dean Hart said one company tried selling one for $40 a pop to a surgeon he knows.
“There’s a whole market of knock-off tests, so home tests will be great. That’s going to be wonderful, but they’re not available legitimately at this point in time,” Hart said.
That’s why U.S. Sen. Chuck Schumer on Sunday sent a letter to FDA Commissioner Stephen Hahn requesting the agency ramp up policing of tests sold online, publicly list which tests are approved and not approved, and penalize companies that do not notify the FDA of their accuracy by issuing cease and desist orders, and imposing large fines.
Given the national emergency, the FDA is allowing some companies to sell antibody tests without approval if proof of accuracy is provided and it is done in a high complexity lab. However, at-home tests do not fall in that category.
“There is no excuse for not having all of the tests approved,” Schumer said. “Imagine if it doesn’t work and it’s an antibody test, you get a false positive. You think you have the antibodies and you go out on the street and you could get COVID.”
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The only at-home testing kit approved by the FDA is called Pixel by LabCorp. It’s a nasal swab for COVID-19 and is only available to first responders and health care workers.
An FDA spokesperson told Rozner the agency is working on providing more clarity for consumers. It is aware of some test developers that are falsely claiming their tests are FDA approved. She said the agency has issued warning letters to those companies and is also detaining fraudulent test kits at the border.