Rapid COVID-19 test developed in Brisbane approved for use in the US

A rapid coronavirus test developed in Brisbane has become the first of its kind to be given emergency approval in the United States.

The US Food and Drug Administration (FDA) approved Ellume's 20-minute COVID-19 Home Test for non-prescription use as it battles soaring cases and deaths from the disease.

The body says the self-test will help reduce the spread of COVID-19 through rapid self-detection, allowing patients to self-isolate instantly.

Dr Sean Parsons founded Ellume after working on the swine flu pandemic and said it was pleasing to see the company's hard work pay off.

"It's new technology that was created here in Brisbane over a long time," he said.

"It's terrific to see this product approved by the FDA in these tumultuous times to help respond to coronavirus."

Developed and manufactured in south-east Queensland, Ellume's tests are self-contained and can deliver a result in as little as 15 minutes.

It works by applying a nasal swab to the testing device, which then connects to a smart phone that uses a free app to analyse and deliver a result.

"What we've been able to do is miniaturise a large instrument, into this device, which bluetooths into your phone and does all of the analysis for you," Dr Parsons said.

"The innovation that we've delivered is being able to deliver a high performance, well-priced instrument that is able to move into a consumer market."

Head of the FDA Stephen Hahn hailed the authorisation as 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.

"As we continue to authorise additional tests for home use, we are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes."

Despite the approval for use in the US, the tests will not be rolled out in Australia, which uses a different set of regulations.

Dr Parsons said due to Australia's good handling of the virus, the product wouldn't be needed here.

All of Ellume's devices come from its factory at Richlands, in Ipswich, that is currently producing 100,000 test kits per day.

Plans are now being developed to ramp up production to 200,000 per day by March next year.