The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to digital diagnostics company Ellume ’s at-home Covid-19 viral antigen test.
Developed with $30m contract and technical support from the National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) Initiative, the Ellume Covid-19 Home Test will be available without a prescription for use at home.
It can be used for detecting active Covid-19 in adults and children aged two years or above with or without symptoms.
Ellume founder and CEO Dr Sean Parsons said: “As Covid-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing.
“Ellume’s Covid-19 Home Test delivers this important first line of defence – it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage.”
For the test, the sample is collected using a mid-turbinate nasal swab.
The sample is then inserted into a single-use cartridge that delivers results in 15 minutes.
In addition, the at-home test analyser connects to the user’s smartphone via Bluetooth. It pairs with an app that gives step-by-step guidelines and displays results.
The test costs approximately $30. With it, users can share real-time results with healthcare specialists, employers, and schools.
The company expects to scale up manufacturing to supply millions of home tests a month next year.
In data submitted to the FDA from a clinical study on 198 subjects aged two to 82 years, the Ellume Covid-19 Home Test showed 96% accuracy with an overall sensitivity of 95% and specificity of 97% versus an emergency use-authorised RT-PCR laboratory test.
Furthermore, the test showed a sensitivity of 96% and specificity of 100% in people with symptoms and sensitivity of 91% and specificity of 96% in asymptomatic people.