Swiss biotech company Roche Holdings said it has devised a test that is 100% accurate at detectingantibodies and 99.8% accurate at ruling them out.
Roche expects to be producing millions of the tests this month and 100 million a month later this year, the company said Sunday. The U.S. Food and Drug Administration has cleared the diagnostic tool for use. The antibody test, Elecsys Anti-SARS-CoV-2, produces a false positive in only one in 500 tests, according to Roche. The test runs on an instrument that can create a single result in 18 minutes and up to 300 in an hour.
The FDA on Monday said companies making COVID-19 antibody tests must apply for authorization by the agency within 10 days of releasing their products. It also specified what's needed for tests to receive regulatory clearance.
Roche said serology tests can determine whether a person has gained immunity against a pathogen such as the coronavirus. Of the more than 200 antibody tests that have flooded the market, the FDA has granted emergency use authorization to only 12 tests. Most tests now in use were not reviewed by the agency.
"We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety," the FDA said in a statement.
The tests are viewed as a crucial part of reopening the economy, but some have been troubled by accuracy concerns in the rush to get to market. The White House last week acknowledged the issue, advising that multiple antibody tests should be used to access the spread of the virus, which has infected more than a million Americans and killed nearly 69,000.