US begins crackdown on unvetted virus blood tests

 U.S. regulators are moving ahe with a crackdown on scores of antibody tests for coronavirus that have t yet been shown to work.

Food and Drug ministration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on market or alrey pulled ir products.

ncy said in a statement that it expects tests "will t be marketed or distributed.” It was unclear if any of companies would face ditional penalties.

Most companies faced a deline earlier this week to file paperwork demonstrating ir tests’ performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said h created a “Wild West” of unregulated testing.

FDA website shows more than 175 tests have eir filed applications with ncy or are in process of doing so. A dozen companies have alrey been reviewed and authorized by FDA to sell tests after meeting requirements for accuracy and reliability.

“We have seen a high level of collaboration and engment from developers who want to get this right," said FDA Commissioner Stephen Hahn in a statement.

Antibody tests are different from nasal swab tests currently used to diagse active infections. Inste, tests look for blood proteins called antibodies, which body produces days or weeks after fighting an infection. Most use a finger-prick of blood on a test strip.

An antibody test might show if you h COVID-19 in recent past, which most experts think gives people some protection.

But studies are still underway to determine what antibody level would be needed for immunity. It’s also t yet kwn how long any immunity might last or wher people with antibodies can still spre virus.

For w, antibody tests are most useful for researchers trying to track how virus spres in communities.

Under pressure to increase testing options, FDA in March essentially allowed companies to begin selling antibody tests as long as y tified ncy of ir plans and provided disclaimers, including that y were t FDA-approved.

FDA is w working with National Institutes of Health and or federal health ncies to vet accuracy of tests, and determine how y can be used to track and contain virus.