“It’s taken 10 years to develop the core technology, and it’s taken about four months to create the current tests,” Dr Parsons said.
“Our core technology is very well suited to detecting COVID, just as it was developed to detect flu.”
The tests are not a front-line swab test that is being used by Australian authorities to detect active cases of the virus but a blood test that looks for antibodies to COVID-19 – what is known as a serology test.
The digital tests are done on a portable device and take about 10 minutes to produce results, with the device able to process up to eight samples simultaneously, or up to 32 tests an hour.
Dr Parsons said that was useful for a country such as the US, where the virus was widespread in the community.
“This is a test to see if you’ve had COVID-19 in the past, to give more information as to what could be making you sick today,” he said.
“But also especially in America, people have had COVID and are therefore at a much lower risk of getting it again – they can hopefully get back to work, and school, and life.”
Despite being a Brisbane company, the tests will be going at this stage only to the US, where Qiagen is seeking regulatory approval from the FDA. But Dr Parsons said the company also had plans to bring the tests to other countries, including Australia.
They would need to seek approval through Australia’s Therapeutic Goods Administration, which has resisted approving self-diagnostic serology tests in Australia, particularly for COVID-19.
“Testing for serious infectious diseases, such as COVID-19, should be conducted in conjunction with a medical practitioner, who can provide an individual with appropriate advice and treatment,” the TGA said in its guidelines for applying for approval of testing systems.
While it is up to Qiagen to apply for approvals, Dr Parsons said, Ellume as the manufacturer of the kits would like to see it rolled out as widely as possible, because he believes it can be an effective tool as the pandemic continues.
“We felt that the best way to respond to pandemics was with high-performance rapid diagnostics. We wanted to be able to respond to flu and put diagnostic tools in the hands of both doctors and consumers,” he said.
Stuart Layt covers health, science and technology for the Brisbane Times. He was formerly the Queensland political reporter for AAP.