America's Food and Drug Administration today authorised the first rapid coronavirus test that doesn't need any special computer equipment to get results.
The 15-minute test from Abbott Laboratories will sell for US$5 ($7.50), giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.
It's the latest cheaper, simpler test to hit the United States market, providing new options to expand testing as schools and businesses struggle to reopen and flu season approaches. The FDA also recently greenlighted a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks.
Both tests have limitations and neither can be done at home.
Several companies are developing rapid, at-home tests, but none have yet won approval.
Abbott's new test still requires a nasal swab by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories.
And in general, rapid tests like Abbott's are less accurate than lab-developed tests. The FDA said that negative results with Abbott's test may need to be confirmed with a lab test in some cases. The agency granted Abbott's test an emergency use authorisation for patients with suspected Covid-19.
The Food and Drug Administration authorised BinaxNOW, the first rapid coronavirus test that doesn't need any special computer equipment to get results.
The two additions should help expand the number of available tests. The US is now testing about 690,000 people per day, down from a peak of 850,000 daily tests late last month. Many public health experts believe the country will soon need to test vastly more people to find those who are infected, isolate them and contain the virus.
The FDA noted that Abbott's test could be used in a doctor's office, emergency room or some schools. "Given the simple nature of this test, it is likely that these tests could be made broadly available," the FDA said.
Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for Covid-19 screening. While considered highly accurate, the tests rely on expensive, specialised machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, especially during a spike in cases last month.
Government and health experts view rapid tests that can be run outside the laboratory system as key to boosting capacity.
"Those screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders," said Dr Jonathan Quick of the Rockefeller Foundation. The nonprofit group has called for the US to conduct about four million per day by October, mostly rapid, point-of-care tests.
Abbott's BinaxNOW is the fourth rapid test that detects Covid-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself. It's considered a faster, though sometimes less precise, screening method. The other tests need to be inserted into a small machine.
Yale's saliva-based test, which is expected to cut the time and cost compared with similar tests, is the fifth Covid-19 saliva tests approved by regulators. All require lab processing.
