A world first for Covid-19 self testing.

by The REJIGIT Blog

01 February 2021

This new product will appeal to anyone who may be obliged to queue for up to eight hours for Covid-19 testing.

The US Department of Defence and the US Department of Health and Human Services have just announced the awarding of a federal funding package of US$231.8m to Australian biotech company Ellume to facilitate the supply of its at-home Covid-19 self-test kits in the United States. A White House Covid-19 advisor indicated that the initial price of the test kit is approximately US$30 and will reduce when mass production and scale is achieved.

The agreement includes funding to support the establishment of Ellume’s U.S. based manufacturing facility and the delivery of 8.5 million Covid-19 home tests which will be distributed throughout the U.S. in accordance with the National Strategy for the Covid-19 Response and Pandemic Preparedness plan.

Ellume has expanded its manufacturing facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere and is rapidly expanding its manufacturing facilities and supply chain in the U.S. Ellume will ship in excess of 100,000 tests per day beginning March and plans to manufacture and deliver 20 million Ellume Covid-19 home self test kits to the U.S. within the first half of 2021.

The kit is the only diagnostic tool authorized by the U.S. FDA for non-prescription use as a screening tool in the United States. The Self-Swab Kit is also registered on the Australian Register of Therapeutic Goods. The detection device’s novel detection technology is powered by unique quantum dot nanoparticles and integrates optics, electronics, biologics and software into an intuitive high-performance digital platform. The test has demonstrated 96% accuracy in an independently run, US clinical study covering five states and has confirmed to be a safe and simple-to-use test for the detection of SARS-CoV-2 nucleocapsid antigen for those aged 2 years and older. The rapid self-test enables individuals to test for active Covid-19 infection in fifteen minutes or less.

Ellume’s Covid-19 home test operates in conjunction with a free software application which is available for download onto the user’s smartphone. The dedicated app provides step-by-step instructions including a how-to-use video and displays the result when the test is complete. Analysis is carried out by the device’s electronic analyser which connects to the user’s smartphone via Bluetooth. The device’s core technology combines ultra-sensitive optics, electronics and proprietary software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology.

The test kit includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth enabled analyser.

Rejigit has previously written about Ellume's Medical Self-Diagnosis Technology. http://www.rejigit.co.nz/vendor/article.php?uid=hp