WASHINGTON (AP) – US health regulators take on three companies to sell blood tests for coronavirus at home, warning that the products have not been shown to screen safely and accurately for COVID-19.
The Food and Drug Administration sent warning letters to the companies on Wednesday, saying their products are illegal because they have not been reviewed by the home agency. While the FDA has approved a handful of tests that allow patients to collect saliva samples at home, the agency has not approved tests for complete home use.
Testing at home carries risks because consumers may misuse the sample or misinterpret the results.
The companies targeted by the FDA are: Medakit Ltd. from Hong Kong, Antibodiescheck.com from the United Arab Emirates and Sonrisa Family Dental from Chicago.
The letter to the Chicago company highlighted online messages promoting “15-minute Covid tests for the whole family!” Among other violations, the company falsely claimed that its products were “FDA approved” and approved the FDA logo without permission, the agency said.
“Such behavior will not be tolerated by the FDA and we will continue to monitor tests marketed in the US,” said Dr. Jeffrey Shuren, FDA director of medical devices, in a statement.
Emails and phone calls to the companies were not immediately returned.
The warning letters are not legally binding, but the government can take companies to court if ignored. The letters give companies 48 hours to report how they will correct the violations.
Wednesday’s action comes when the FDA tries to monitor dozens of antibody tests that the agency admitted to the market earlier this year without evidence that they were working. On Tuesday, the FDA revoked the authorization of an antibody test it previously cleared after it was determined to yield too many inaccurate results.
FDA leaders said the original flexible policy was designed to boost testing options and supplies, but critics said the agency created a “Wild West” of unregulated testing. Last month, the FDA said that companies must submit test data to remain on the market.
Antibody tests are different from the nasal swabs used to diagnose the most active infections. The tests instead look for blood proteins called antibodies, indicating that someone had a previous infection. Most tests use a fingerstick of blood on a test strip.
Antibody tests were initially believed to play a key role in identifying people who have developed some immunity to the virus. But researchers have not yet determined how to interpret the results in terms of immunity. And even high-performing antibody tests can sometimes yield more false results than accurate ones.
The FDA has granted 21 antibody tests. Meanwhile, about 190 antibody tests initiated under the service’s previous policy are awaiting review.
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