Food and Drug Administration clears 10-minute covid-19 test

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The Food and Drug Administration has cleared a 10-minute covid-19 test that doesn’t need added equipment to process, manufacturer Access Bio said Tuesday.

The assay, known as CareStart, is among a group of new antigen tests that detect the novel coronavirus by looking for proteins on its surface.

Because antigen screening can provide rapid results in doctor’s offices, urgent care clinics and hospitals, they could have a key role in expanding access to testing and providing timely information to patients and providers. But use of these tests has remained limited. The government purchased many early tests for use in nursing homes, with efforts ongoing to extend the assays into states more broadly and settings like schools.

“To reopen society, we’re going to need to have these rapid tests,” said Reeve Benaron, founder of Intrivo Diagnostics, Access Bio’s U.S. arm.

CareStart is a self-contained, single-use product that operates using lateral flow technology, similar to at-home pregnancy tests. The assay includes a swab, a vial of extraction solution and a cassette the size of a small flash drive. A line appears visible on the cassette if the test is positive, and it doesn’t require special training to administer, said Crystal Nguyen, head of research and development at Intrivo.

The cost will be under $20 a test, though the exact price depends on the volume purchased, Benaron said. That makes it competitive with a $20 antigen test sold by Becton Dickinson & Co. that requires added equipment to produce a result.

Another self-contained antigen test from Abbott Laboratories cleared for U.S. sale this summer is priced at just $5. The U.S. government bought 150 million of Abbott’s BinaxNOW antigen tests in late August, which it is distributing to states, potentially for use in places like schools, as well as elder-care facilities, historically Black colleges and universities and Native American tribes.

November Sales

The company plans to begin selling the tests in November, with goals of producing about 10 million monthly by the end of November, and 60 million to 80 million a month by the middle of February, when a new facility is expected to open, according to Benaron.

The vast majority of tests produced will be sold in the U.S., to health-care facilities, the government and the private sector, he said.

Benaron said he’s heard particular interest in the antigen test from leaders of Fortune 500 companies. “They’re being forced to make medical decisions. They’re no longer just CEOs,” he said. “It’s just unprecedented, uncharted waters.”

Antigen screenings, though speedy, are also less accurate than the gold-standard PCR diagnostic tests, with concerns largely revolving around the tests missing people who are infected.

False Positives

Worries about the opposite phenomenon, or false positives, led Nevada to tell nursing homes this month to stop using antigen tests to screen residents and workers. Manufacturers and government officials, however, say some false positives are inevitable with any test.

CareStart is 88.4% sensitive, a measure of how often it correctly identifies infections, and 100% specific, the rate of correct negative tests, Nguyen said.

“It’s not meant to replace PCR” and, in fact, a positive result will be confirmed with a PCR test, Benaron said.