The over-the-counter diagnostic test will help detect active Covid-19 in individuals with or without symptoms
Digital diagnostics company Ellume has secured an emergency use authorisation (EUA) from the US Food and Drug Administration for its rapid and at-home Covid-19 antigen test.
The over-the-counter diagnostic test will be used for non-prescription home use to detect active Covid-19 in individuals with or without symptoms, as well as in adults and children aged two years and above.
Claimed to be the first of its kind to receive FDA EUA, Ellume Covid-19 home test will enable rapid self-detection and deliver real-time results at home.
According to the company, the test demonstrated 96% accuracy in an independent and simulated home-setting clinical study of 198 subjects aged between two years and 82 years.
The home test’s core technology integrates ultra-sensitive optics, electronics and proprietary software to leverage advanced digital immunoassay technology with next-generation multi-quantum dot fluorescence technology, said the company.
The patented detection method uses unique fluorescent nanoparticles and an advanced reader system to identify minute fluorescence signals, thereby enabling to generate precise results from a clinical sample and address the sensitivity limitations of typical lateral flow technology.
Ellume’s test consists of sterile nasal swab, dropper, processing fluid and Bluetooth connected analyser, which can be used with an app on the user’s smartphone.
The app offers easy-to-read and step-by-step instructions, including a how-to-use video. The electronic analyser of the test conducts complete analysis, while Bluetooth connectivity allows to show test results on the user’s smartphone within 15 minutes.
Ellume is scaling the manufacturing of its range of Covid-19 diagnostic tests using $30m WP-2 grant from the US National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative.
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 defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”
In November, Lucira Health has secured EUA from the US FDA for its at-home self-testing Covid-19 diagnostic kit, a molecular single-use test developed for the detection of the novel coronavirus SARS-CoV-2.