While the test will be useful in fighting the pandemic, experts say it will not dramatically change the diagnosis landscape.
Soon, people in the United States will be able to pick up a rapid antigen test for Covid-19 from their local drugstore without a prescription, test themselves and process the results at home. The Ellume Covid-19 Home Test that was granted an emergency use authorisation from the Food and Drug Administration is expected to cost $30, is easy to use and produces results within 20 minutes. The Ellume test is currently the most versatile rapid antigen test because it is authorised for testing anyone age 2 years or over, whether they have symptoms or not. It is an antigen test that detects viral proteins, as opposed to the gold-standard PCR tests that detect viral genetic material. The Ellume test includes a smartphone app that provides step-by-step instructions explaining how to take a nasal swab and place it into the small analyser that processes the sample. The app connects to the analyser via Bluetooth to display the test results on the user’s phone. It is also possible to transmit test results securely and anonymously to public health authorities via the app, which helps provide data to guide Covid-19 policy decisions. Independent testing by the National Institutes of Health confirmed that the Ellume Covid-19 Home Test successfully identified 96% of PCR-confirmed Covid-19 positive cases in people with symptoms and 91% of PCR-confirmed cases in people without symptoms.
