Queensland health technology manufacturer Ellume’s state-of the-art automated assembly lines are being installed at its manufacturing site in Richlands, in south-west Brisbane, this August. By Carole Goldsmith.

Built by Bosch Australia’s Manufacturing Solutions Division (BAMS) team, working closely with Ellume’s engineering team, the two lines were tested at Bosch’s plant in Melbourne, before installation at Ellume’s facility.

A further 16 lines will be built at Bosch and bound for Ellume’s new US production plant in Maryland, scheduled to open later this year. The Washington Post reported on 1 February this year that the US Government had awarded a US$231.8m contract to Ellume to supply 8.5m of its Rapid at Home COVID-19 Tests. These products have been produced in Australia to date, and when the Maryland site is running, it will have the capacity to produce over 15m tests per month.

Ellume’s founder and CEO, Dr Sean Parsons, told the Post that he believes that scaling up production will allow Ellume to reduce the test’s price (currently at US$30 a test). By manufacturing the tests in the US, Ellume will no longer have to ship them from Australia. To date more than one million tests have been shipped from Ellume’s Brisbane plant to the US between February and July this year.

Romulo De Macedo, Head of Engineering at Ellume, is a former project engineer for Bosch, having worked at both its Australian and German plants. Now leading the Ellume assembly team, he explains: “We formed a partnership with Bosch in developing these lines for our Australian and US manufacturing sites, in January last year. Ellume’s Program Manager Steve Carter is overseeing our US site’s build and operations.”

Around 60 Bosch employees and around 30 of Ellume’s employees have been working on building and installing the assembly lines, which will increase production capacity. The lines include end-of-line functional testing to ensure reliable product quality. De Macedo adds that the lines use standard automation equipment such as robots, vision systems, active movers and conveyor feeding systems.

“What is really unique about our lines and a first-of-its-kind is that we combine assembly of standard electronic and mechanical plastic parts with the biological lateral flow assay,” he says. “This is unique, and we have managed to marry the two technologies together. Ellume is also first in the world in developing the COVID home test.”

Dr Scott Fry, Ellume’s Chief Operating Officer, describes the manufacturing process: “The lateral flow assay porous membrane materials, impregnated with biologicals that are produced in-house, are put on reels which are converted to a strip on our automated line. Then it’s assembled onto the electronics and plastics. Everything has to be precisely aligned. Each new line can potentially produce 30,000 to 35,000 Ellume COVID home test kits per day, which will all be bound for the US.

According to Dr Fry, one of the unique features about Ellume’s product is its wireless Bluetooth connectivity. It wirelessly connects to the user’s own smartphone when they are running the diagnostics test. The test data from the user can be shared instantly with public health and with the person’s own GP for subsequent telehealth consultations.

“The Bosch auto lines have a unique wireless contact-free design for programming and testing the device at high throughput,” he adds. “This includes loading the electronics with its firmware and conducting an electronic self-test.”

The home test is suitable for ages two years and over. It’s available for non-prescription home use in the US. The product’s technology enables individuals with or without symptoms to test for COVID-19 infection in 15 minutes, anywhere in the country.

“It’s approved by the US FDA for emergency use, and it is cheaper for consumers to self-test themselves for COVID than pay to visit their GP and to have a test performed at the point of care, or in a laboratory,” says Dr Fry. “The test’s results identify positive cases, and enable public health to know the COVID hotspots and conduct contact tracing. Australia has no legislation for consumer testing of COVID but it is presently under review.

“In the US, it’s about proving safe and effective home tests, which we have done. It’s designed for consumers, and it’s very simple and accurate to use,” adds Dr Fry. “We want to be the global leader for diagnostics home testing for consumers and assist the world to be more prepared for responding to the next pandemic.”

www.bosch.com.au

www.ellumehealth.com