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FDA authorizes first rapid, over-the-counter, at home coronavirus test

at home coronavirus test fda authorizes ellume rapid over the counter test kit
Photo via Ellume

The U.S. Food and Drug Administration has authorized the first rapid, over-the-counter, at-home coronavirus test, providing people an important tool in fighting the ongoing COVID-19 pandemic. 

According to the Washington Post, the test, created by Australian company Ellume, is the “first rapid coronavirus test that can be taken at home without prescription and that yields immediate results.” The test doesn’t require samples to be sent to a lab, and according to the company, it can be used by anyone over the age of 2. 

The test, which will cost about $30, is expected to ship in the first week of January—but the Post notes there are concerns about making it widely available and making sure that people don’t hoard supplies of the test by buying it in bulk. 

FDA Commissioner Stephen Hahn declared on Dec. 15, “Today’s authorization is a major milestone in diagnostic testing for COVID-19,” according to NPR.

The test kit comes with a swab allowing the user to collect a sample inside the nose. The swab includes an adapter that allows it to be used for younger children. Once the sample is taken, the user adds a few drops of liquid and places the swab into a small plastic device. The results are wirelessly transmitted to a smartphone app that the user must download. 

That app automatically sends data to the cloud with the user’s zip code, according to the Post. That will allow regional health officials to know about positive results while keeping an individual’s data confidential.

“This is the first test which is really designed to be a true at-home test yourself and obtain a result,” said Ellume’s CEO Sean Parsons in an interview with NPR. “This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to a church to decrease the chance that they spread it [to] other people.”

The company expects to produce 100,000 tests a day in January with plans to ramp that up to 250,000 tests by March and 1 million tests by June. 

The test is 96% accurate, according to both the FDA and Ellume, using an antigen-based method. According to NPR, antigen tests like the Ellume at home coronavirus test, tend to be less accurate than PCR tests, which detect genetic material from the virus.

Sources: Washington Post, NPR


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