Coronavirus Ellume at-home test developed in Brisbane approved for emergency use in US

A new at-home coronavirus test, developed by a Brisbane company, has been approved for emergency use in the United States.

The Ellume COVID-19 Home Test is designed to detect fragments of the virus from a nasal swab sample from a person as young as two years old.

US Food and Drug Administration (FDA) commissioner Stephen Hahn said the authorisation of the test was a major milestone in diagnostic testing for COVID-19.

"By authorising a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes," he said.

The chief executive of Ellume Health, Dr Sean Parsons, told ABC Radio Brisbane that this was the first true at-home, non-prescriptive test for the virus to be approved, and it was developed in Brisbane.

"It's really the first time that there's a product available to enable widespread testing and screening," Dr Parsons said.

The test was authorised for use by people both with and without symptoms, with instructions on how to correctly use the swab available on an app.

"You do have to stick something up your nose … [but] it's not one of the swabs that goes all the way back and feels like it's tickling your brain," he said.

"You take a … swab, you apply it to the test, and you have a result within 20 minutes."

Clinical tests found a 96 per cent accuracy in results

Dr Parsons said the team had to prove people could swab themselves reliably.

"We've had to build in special controls so that if someone doesn't take a proper swab, then they get a 'test failed' not a 'negative' result," he said.

While clinical tests found the test to be 96 per cent accurate, the FDA said, similar to other antigen tests, a small percentage of positive and negative results could be false.

It said for patients without symptoms, positive results should still be treated as presumptively positive until confirmed by another test as soon as possible, while individuals with symptoms who produce negative results should still follow up with their healthcare provider.

Dr Parsons said they were still working on commercial distribution, but have had a lot of interest from universities keen to have students return to campus, and sporting events eager to test spectators.

"There's a lot of options around that," he said.

"Our biggest challenge is making enough tests to meet the demand America currently has."

He said there was not a demand for the tests in Australia yet, but that might change.

Australian Acting Chief Medical Officer Professor Paul Kelly said while he welcomed the news, Australia did not have the same emergency as the US.

"They're clearly looking to give this Emergency Use Authorisation, which is not full regulatory approval, for this particular test," he said.

"We have some tests like that on our Australian register of therapeutic goods — so are licensed for use in Australia. That particular product is not licensed.

"The other thing that's different here in Australia is, we have a very large and deliberately expanded laboratory network using the gold standard of PCR testing. We have plenty of capacity there."

Another Queensland-developed aid goes global

A team of healthcare professionals based at Brisbane's Prince Charles Hospital has helped develop a COVID app bringing crucial data to doctors in intensive care wards.

The IBM technology called COVID Critical is now being used by more than 500 clinicians at 370 hospitals around the world.

COVID Critical founder John Fraser, who is also a researcher at the University of Queensland, said the app smoothed the process for doctors to make the right decisions about their COVID patients.

"Initially, before we created this tool, people were just sharing data on WhatsApp messages, asking their colleagues, and they would get their ideas from one or two previous patients," he said.

"But you can imagine how much more useful it's been when they can look at 5,000 patients' data.

"Being able to give a real-time, dynamic picture of what's going on across the globe, delivered into the doctor's or nurse's hand at the bedside via an app, is phenomenal."

The web-based app, which runs on the IBM cloud, was built by seven designers and developers in Australia and New Zealand in just seven weeks.

IBM worked with medical researchers and data scientists at the University of Queensland (UQ), with support from the Queensland University of Technology (QUT), taking advice from COVID Critical's 54 member countries.

IBM Australia managing director Katrina Troughton said they really wanted to establish what clinicians needed in those crucial moments at the bedside of a patient in ICU.

"What they had was either an excel spreadsheet or a dashboard that was a behemoth of graphs and reports that wasn't consumable in a real critical, timely manner," she said.

She said after the technology was successfully tested in Australia and the US, it could soon be used across six continents.

"We anticipate that the global interest could result in up to 6,000 clinicians signing up to use it in the coming months," she said.

Professor Fraser said the concept of an app to share medical data was one that could prove useful for the treatment of other diseases in the future.

"It will change the way we do things in COVID, in terms of data sharing, and I think it could be even more long lasting than COVID," he said.

"Doctors work with data … giving us more data allows us to see what's happening across the world."