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New Test Can Provide Results in 20 Minutes

FDA approves kit that requires no prescription and connects to app
By Newser Editors and Wire Services
Posted Dec 15, 2020 1:59 PM CST

(Newser) – The first home test for COVID-19 that doesn't require a prescription will soon be on US store shelves. Regulators on Tuesday authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important—though incremental—step in efforts to expand testing options, the AP reports. The approval allows the test to be sold in places like drugstores "where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes," said FDA Commissioner Stephen Hahn in a statement. Regulators granted emergency use for a similar home test last month, but that one requires a doctor's prescription. Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.

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A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online. The kit includes a nasal swab, a chemical solution, and a testing strip. The test connects digitally to a smartphone app that displays the results and then helps interpret the results. Users can also connect with a health professional via the app. For months, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health processional that must be processed at high-tech laboratories. That typically means waiting days for the results. About 25 tests allow people to collect their own sample at home—a nasal swab or saliva—but then that's shipped to a lab. The US is testing nearly 2 million people per day, but most health experts agree it needs to be testing many times more.

(Read more coronavirus stories.)

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