The first home test for COVID-19 that doesn’t require a prescription will soon be on U.S. store shelves.
On Tuesday, U.S. regulators authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important step in efforts to expand testing options.
Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription.
The test will be sold in 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.
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.
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.
A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.