The Food and Drug Administration has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment.
Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country’s testing bottleneck by greatly increasing overall capacity and the speed at which results arrive. The United States has tested about 22 million people in the last month.
Abbott’s test is designed for use within seven days of the onset of symptoms. It gives results on a card reminiscent of the stick used in many over-the-counter pregnancy tests. If one line appears on the card, the patient is negative for the coronavirus; two lines indicates a positive result.
Health care providers still must administer the test but it can be done in point-of-care settings like offices.
Former FDA Commissioner Scott Gottlieb told POLITICO the test will help democratize testing in areas of the country with less access to health care and could also boost testing in schools and workplaces. “This is the kind of innovation we badly need,” Gottlieb said.
Jeff Shuren, the FDA’s head medical device regulator, said the test’s quick turnaround and easy-to-read results card “means people will know if they have the virus in almost real-time.”
Data that Abbott submitted to the FDA show that the test accurately detects 97.1 percent of positive samples and 98.5 percent of negative samples.
The company says it plans to ship “tens of millions” of the tests to customers beginning in September, and is on track to manufacture 50 million tests a month from October on.
Abbott is also releasing a smartphone app that could allow people to display test results from their health care provider via a QR code when entering a public space.
“It’s exciting to see something come on the market that’s fast, easy to use, can be made by the millions and is inexpensive,” said Scott Becker, CEO of the Association of Public Health Laboratories.
The FDA’s announcement that it authorized the test comes hours before Vice President Mike Pence, who has led the U.S. government’s coronavirus response, is set to address the Republican National Convention.
Abbott CEO Robert Ford hinted that the test was on its way to market during the company’s July 16 earnings call, but declined to give specifics on when the company expected FDA to authorize the test.
Meanwhile, the federal government has taken action in recent days to expand use of antigen tests like the Abbott product. The FDA said Monday that health providers can use antigen tests, which are less accurate than lab tests, to screen people without coronavirus symptoms on an “off-label” basis if lab turnaround times are too long.
The agency cautioned that negative results from such tests should be considered as presumptive negatives, and that different approaches, like repeated testing of the same person, should be considered.
The FDA recommendation came out the same day that CDC updated testing guidelines to state that people who have been exposed to the virus, but aren’t showing symptoms and don’t have underlying risk factors, don’t necessarily need to be tested. The change, made at the behest of White House coronavirus task force officials, frustrated public health experts who say it runs counter to current science.