And thanks can be given to a smart young doctor, Sean Parsons, who was working at Caboolture hospital in 2009-10 when the swine flu pandemic hit Asia.

He understood then how important a fast, accurate virus test kit was. After 10 years and millions in developmentas well as support from US authorities, Ellume has cracked the massive American market with a kit that costs about $US30 ($A40) and can provide an answer in about 15 minutes.

“Scores of patients were presenting with symptoms of influenza,” Parsons said of his time at Caboolture.

“Laboratory tests took several days to return results and the small range of rapid influenza tests available lacked accuracy and reliability. Inappropriate prescribing of antivirals and antibiotics was unavoidable, as was non-prescribing for influenza infected patients.

“It was then that I realised there was a clear need for a faster, simpler and more accurate way to diagnose influenza and other infectious diseases.”

The early development was for a flu test and was being done in conjunction with an American company Qiajen. When the pandemic hit Ellume was able to adapt the test kit.

Parsons said it would allow people to test themselves before going to events such as the football or a concert and prevent the spread of the virus.

The test kit has yet to get acceptance from Australian authorities although the Palaszczuk Government provided funding last month to help Ellume commercialise production.

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.

It is the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic, Ellume said.

In order to meet anticipated demand, Ellume has expanded its manufacturing facility in Brisbane,  the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain within the US.

Production has already commenced and Ellume will be shipping over 100,000 tests a day from next month. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the US within the first half of 2021.

The Ellume self-test will help reduce the spread of COVID-19 through rapid self-detection, providing users with real-time results at home, enabling self-isolation and patient education on escalation of medical care.

Ellume said that alongside the recently authorised COVID-19 vaccine, Ellume’s self-test will provide critical support to the United States as it transitions out of the pandemic, delivering rapid, accurate test results and facilitating a safe return to workplaces, educational institutions, and travel.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,”  Parsons said.

“Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

Testing of 198 subjects ranging in age from 2 years to 82 years, the Ellume COVID-19 Home Test demonstrated 96 per cent accuracy, with an overall sensitivity of 95 per cent.