An at-home, over-the-counter test for SARS-CoV-2 has received an Emergency Use Authorization from the US Food and Drug Administration, as 360Dx reports. It adds that this is the first at-home test for SARS-CoV-2 to receive an EUA that doesn't require a prescription.
The test from the Australian diagnostics firm Ellume is a rapid, lateral flow antigen test that uses a nasal swab and a smartphone app to deliver results. According to the FDA, the test identified 96 percent of positive samples and all negative samples in individuals with symptoms and, among those without symptoms, identified 91 percent of positive samples and 96 percent of negative samples.
The Washington Post adds that the test will cost about $30 and could help the US in its fight against COVID-19. "It's a big deal, and a huge step for efforts to take back control from the virus," Mara Aspinall, a biomedical diagnostics professor at Arizona State University, tells it.
Ellume says it will begin shipping tests at the beginning of January, according to the Post.