FDA authorised Ellume Covid-19 Home Test for non-prescription home use in symptomatic and asymptomatic individuals
Ellume COVID-19 Home Test for non-prescription home use. (Credit: Ellume Limited.)
Ellume has obtained the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its rapid, at-home Covid-19 antigen test.
The test is intended for non-prescription home use to detect active Covid-19 in individuals with or without symptoms, and in adults and children aged 2 years and older.
The Australia-based digital diagnostics firm said that its new test is the first fully at-home Covid-19 test to receive an EUA and helps in the fight against the ongoing Covid-19 pandemic.
Also, the rapid at-home self-detection offered by the test would reduce the spread of Covid-19, and the real-time results will enable self-isolation of the patients.
Ellume founder and CEO 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.”
Ellume has developed the core technology for its Covid-19 Home Test, which combines ultra-sensitive optics, electronics and software to leverage advanced digital immunoassay technology with next-generation multi-quantum dot fluorescence technology, over ten years.
The at-home Covid-19 self-testing kit includes a sterile nasal swab, dropper, processing fluid, and a Bluetooth connected analyser for use with a free software application on the user’s smartphone.
The dedicated app will help the users follow step-by-step video instructions to perform the test. The electronic analyser will perform all the analysis and will display the test results on the user’s smartphone within 15 minutes, using Bluetooth connectivity.
Ellume Covid-19 Home Test showed 96% accuracy, 95% sensitivity and 97% specificity
Ellume has filed the regulatory application with the FDA, based on an independently conducted simulated home-setting clinical study in 198 subjects.
In the study, Ellume Covid-19 Home Test showed 96% accuracy, with 95% overall sensitivity and 97% specificity, compared to an emergency use-authorized RT-PCR laboratory test.
The Ellume Covid-19 Home Test showed 96% sensitivity and 100% specificity in patients with Covid-19 symptoms, and demonstrated a 91% sensitivity and 96% specificity in asymptomatic individuals, said the company.
Ellume has secured a $30m funding support, as part of WP-2 grant from the US National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, to advance the development of the Covid-19 diagnostic tests.
Emory University, Georgia Institute of Technology, and Children’s Healthcare of Atlanta conducted an independent, analytical evaluation for the NIH RADx Tech programme.