FDA approves COVID-19 take a look at that doesn’t require particular tools
The Food and Drug Administration on Wednesday approved the first rapid coronavirus test that doesn’t require special computer equipment to get results.
Abbott Laboratories’ 15-minute test sells for $ 5, giving it a competitive edge over similar tests that need to be built into a small machine. The self-contained test is the size of a credit card and is based on the same technology used to test for flu, strep, and other infections.
It’s the latest cheaper and easier test to hit the U.S. market with new options to expand the tests as schools and businesses struggle to reopen and flu season approaches. The FDA also recently gave the go-ahead to a Yale University saliva test that bypasses some of the supplies that have caused testing bottlenecks.
Both tests have limitations and cannot be done at home. Several companies are developing rapid home tests, but none have been approved.
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Abbott’s new test still requires a nasal swab from a health care professional, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be performed in high-quality laboratories.
And in general, rapid tests like Abbott’s are less accurate than laboratory-developed tests. The FDA said in a statement announcing the decision that negative results with the Abbott test may need to be confirmed by a laboratory test in some cases. The agency issued emergency clearance to Abbott’s test late Wednesday for patients with suspected COVID-19.
The two additions are designed to help expand the number of tests available. The US is currently testing about 690,000 people a day, up from a high of 850,000 daily tests late last month. Many public health experts believe the country will soon have to test far more people to find those 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 widely available,” said the FDA.
Since the pandemic began, nasal swab tests sent to a laboratory have been the standard for COVID-19 screening. Although the tests are thought to be very accurate, they are based on expensive, specialized machinery and chemicals. Shortages in these supplies have resulted in repeated delays in reporting results, particularly during an increase in cases over the past month.
Government and health professionals view rapid tests that can be performed outside of the laboratory system as key to increasing capacity.
“These screening tests are what we need in schools, in the workplace and in nursing homes to catch asymptomatic spreaders,” said Dr. Jonathan Quick of the Rockefeller Foundation in an interview this month. The nonprofit group has requested that the US be doing about 4 million a day through October, mostly rapid point-of-care testing.
Abbott’s BinaxNOW is the fourth rapid test to detect COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself. It’s considered a faster, if sometimes less accurate, screening method. The other tests have to be inserted into a small machine.
Inside the Abbott test is a specially coated strip that interacts with COVID-19 antigens. The patient’s nasal swab is inserted into the card and a few drops of a chemical solution are added. Markers appear on the card to indicate whether the sample is positive or negative – similar to a pregnancy test.
Two other antigen test manufacturers – Quidel and Becton Dickinson – said they could not meet demand for the tests. A third company, LumiraDx, plans to begin shipping its recently approved antigen tests by the end of this month. Abbott expects to begin shipping tests in September and hit 50 million tests per month in October.
The influx of antigen tests will go a long way in meeting the Trump administration’s forecast that 90 million COVID-19 tests will be available per month if needed by September. But the US “test tsar” Admiral Brett Giroir has emphasized that the US can contain the outbreak with far fewer tests.
“That’s the capacity … we don’t need as many tests to reopen safely and sensibly,” Giroir recently told reporters. He pointed to several key indicators that have fallen, including new infections and hospital admissions, even though testing has slowed.
Earlier this month, the FDA approved Yale’s saliva-based test, which is expected to reduce time and cost compared to similar tests. It is the fifth COVID-19 saliva test to be approved by regulators. All of them require laboratory processing.
Developed by the Yale School of Public Health, SalivaDirect can use any sterile container to collect a sample, not the special tube used in previous tests, and requires fewer chemicals. External experts welcomed the new approach but noted its limitations.
“It is not a rapid test, but a laboratory-based test that is still prone to the same massive delays as any other test,” said Dr. Michael Mina from Harvard University.