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COVID-19 Test That Can Work in 5 Minutes Approved by FDA

As the world continues to watch the COVID-19 pandemic evolve, everyone, from YouTubers to government officials, is trying to develop a clearer picture of what to expect from this outbreak of disease. One critical component of developing that picture, is, of course, testing, and now a medical device that can provide positive results for COVID-19 in as little as five minutes has been approved by the Food and Drug Administration (FDA).

Engadget reported on the test, which is being developed by Abbot Laboratories, an American medical devices and health care company headquartered in Lake Bluff, Illinois. If the test looks familiar, that may be because President Trump showcased it for the public at a March 30 press briefing discussing updates on the U.S. government’s response to the pandemic. In the clip below from the briefing, President Trump unboxes the Abbot machine that’s required to run the tests, while the FDA commissioner, Stephen M. Hahn, addresses the public about the current state of COVID-19 testing.

According to Abbot, this test is the “fastest available molecular point-of-care test for novel coronavirus,” and is able to deliver positive results in as little as five minutes, and negative results in as little as 13. Abbot says that “What makes this test so different is where it can be used: outside the four walls of a traditional hospital such as in the physicians’ office or urgent care clinics.” Indeed, Abbot’s CEO, Miles D White, said on Mad Money with Jim Cramer that providing in-home tests will be possible.

The test itself, according to an Abbot product video, works by by detecting the molecular RNA of the SARS-CoV-2 virus, which causes COVID-19. It’s not exactly clear from Abbot’s video or product description whether the tests use blood samples, saliva samples, or some other biological material from a person, but slower, squirm-inducing methods we’ve seen call for (deep) swabbing of the nose and throat.

Abbot’s tests were approved rapidly by the FDA, thanks to the administration’s Emergency Use Authorization (EUA) authority. The FDA’s EUA lets the FDA Commissioner allow for the use of “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions” caused by chemical, biological, or nuclear events.

COVID-19 Test That Can Work in 5 Minutes Approved by FDA_1

The White House

Abbot says that it’ll start delivering its COVID-19 tests to the U.S. healthcare system in early April. It plans on initially producing 50,000 tests a day, but may ramp up to 100,000 a day (per Mad Money interview). Note that these tests will not detect antibodies, and will only work if the SARS-CoV-2 virus is present at detectable levels.

What do you think about these five-minute COVID-19 tests? Do you think the U.S. is going to be able to deliver appropriate levels of testing in April, or will it still fall short of what’s needed? Let us know your thoughts in the comments.

Header Image: The White House