The FDA Just Authorized the Use of a New $5 Rapid COVID-19 Test

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There’s a new cheap and rapid COVID-19 test in our arsenal thanks to an emergency use authorization from the Food and Drug Administration (FDA). And, because it’s less invasive than other commonly used tests and requires very little equipment, it could make testing available to more people.

To administer the new test from pharmaceutical company Abbott, called BinaxNOW, a healthcare provider first swabs a patient’s nose (just into the front nostril area), then twirls the swab on the test card along with a chemical reagent, according to the FDA announcement. From there, the results are displayed directly on the test itself (similar to a pregnancy test), and the test requires no other equipment to process the sample. Results should be available in about 15 minutes and the test is expected to cost $5.

Abbott also says it can produce the tests at a pretty impressive scale: It’s planning to ship “tens of millions” of tests in September and will ramp up to 50 million per month in October, according to a press release. They are not meant for over-the-counter use, but you will likely see them in places like doctor’s offices, emergency rooms, and possibly schools, the FDA says.

Interestingly, the company behind the new rapid COVID-19 test is also launching a free app along with it that will send patients their results. If their results are negative, they’ll receive a “digital health pass” with a QR code that’s similar to an airline boarding pass, according to the press release. If a patient’s results are positive, however, they’ll receive a message instructing them to quarantine and speak with their doctor.  

Unlike the current nasopharyngeal swab tests that can detect viral RNA with a swab plunged deep into your nasal cavities, the new test looks for viral antigens, proteins on the surface of the virus. That makes the new test less sensitive and specific than those looking for viral RNA, which means that it may miss a small amount of positive (about 3%) and negative (about 2%) results. That’s why, just like any other test, the FDA says the results from this one should be taken in context with information about the patient’s other symptoms and any possible recent exposures to COVID-19.

But experts argue that frequent widespread testing with a rapid, less invasive, low-cost—albeit imperfect—test like this can play an important role in reducing the spread of COVID-19. “This significant entry could help democratize testing, making more tests more available to people in more austere settings that don’t have all the trappings found in a medical office; including schools,” Scott Gottlieb, M.D., former FDA commissioner, said on Twitter.

“Terrific news from ⁦@AbbottNews and a MASSIVE step forward towards widescale cheap, simple, rapid tests. This is the type of test that not only will diagnose ppl – but can stop transmission chains,” Michael Mina, M.D., Ph.D., epidemiologist and immunologist at the Harvard T.H. Chan School of Public Health, said on Twitter. The idea is that, with enough scale, we could test basically everyone in a dorm or office, for instance, and catch positive cases early—possibly before people even show symptoms—and quarantine them before they’re allowed to spread the virus.

However, Dr. Mina explained, the FDA authorization only allows this test to be used in people who have symptoms, so this test still isn’t going to fill the need for that type of large-scale testing of an entire population. So, of course, it’s still important to keep up the other public health strategies we all know: Wear a mask, wash your hands frequently, and keep at least six feet away from others in public places. 

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Related:

https://www.self.com/story/fda-authorized-rapid-covid-19-test

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