FDA authorizes first over-the-counter home test for COVID-19
The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves. U.S. officials 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 U.S. efforts to expand testing options.
The agency's action allows the test to be sold in places like drugstores, so "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 rapid at-home test, which detects proteins of the virus known as antigens, is not considered as accurate as the type of molecular tests run in a lab. But the FDA says it could help ease the burden on laboratories and give Americans more testing options.
The FDA's announcement includes a reminder that "all tests can experience false negative and false positive results." It advises people who test positive at home to "self-isolate and seek additional care from their health care provider." Those who test negative but are experiencing COVID-like symptoms "should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection."
Regulators granted emergency use for a similar 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.
A company spokesperson said the test will be priced around $30 and be available at pharmacies and online. The test connects to a digital app to help users interpret the results.