A Rapid, Over-The-Counter, At-Home Covid-19 Diagnostic Test Developed By An Australian Firm Gets US FDA Clearance 

A rapid, over-the-counter Covid-19 test developed by Australian firm Ellume has been given emergency approval in the United States.

A Brisbane based digital diagnostics company Ellume announced on Tuesday (Dec 15) that its rapid, at-home COVID-19 antigen test has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The test will be available for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged 2 years and above.

The Ellume COVID-19 Home Test, which will give results in 20 minutes, will be the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic.

In data submitted to the FDA from an independently run, simulated home-setting clinical study of 198 subjects ranging in age from 2 years to 82 years, the Ellume COVID-19 Home Test demonstrated 96% accuracy, with an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test.

In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.

The Ellume Covid-19 Home Test uses a special nasal swab connected to a smartphone app, which sends the results back to users via bluetooth in as little at 15-20 minutes. To use the app users must enter a postcode and their date of birth, which can be shared with health authorities to monitor outbreaks and conduct contact tracing.

Through a secure cloud connection, Ellume’s COVID-19 Home Test can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.

The company expanded its manufacturing facility in Brisbane after being awarded a US National Institutes of Health’s rapid acceleration of diagnostics grant worth $30m in October.

“As Covid-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” the Ellume founder and chief executive, Dr Sean Parsons, said.

“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.”

The company said it would ship more than 100,000 tests to the US next month and plans to manufacture 20m tests in the first half of 2021.