Current PCR tests simply detect the presence of viral material in a person’s system. While highly accurate, they can’t make a distinction between a “live” virus or dead, inert viral particles, with some people testing “positive weeks or even months” after they first test positive.
Griffith University infectious diseases expert Lara Herrero, who was not connected to Microbio or the development of its tests, said the fact that the company had been given the green light in Europe was a very positive first step to the tests being rolled out in other parts of the world, including Australia.
Dr Herrero said she believed the tests could provide a valuable “second tier” testing capability for health authorities trying to contain COVID-19 outbreaks.
“Let’s say you’ve tested positive with a current PCR test, but authorities are not sure whether you have an active infection or not,” she said.
“If you use this test, it can be verified that you have a current infection and you must quarantine. But it would definitely be a two-stage process.”
Dr Herrero said she would not be comfortable with the R-Test being used as a more primary screening test because it was not immediately clear how the test handled false negatives.
“I think if someone tested negative using this test, that information would have to be handled with care on a case-by-case basis,” she said. “But it does appear to be very useful in what it can detect in positive cases.”
In the wake of the European approval, Microbio plans to deliver 500,000 tests a week from a manufacturing facility in Canada. It is also investigating whether it can roll out manufacturing in Australia.
Dr Huygens said Microbio hoped the European approval would help pave the way for approvals in other markets, including North America and Australia.
“We have been struggling to get our test verified in Australia, so when we approached some international partners in the UK, US, Italy and India, those testing labs were very interested to use our test for validation,” she said.
“Obviously we do still want to approach Australia – we actually want to do another trial in Australia because we want to put the R-Test in a setting like quarantine hotels, where we can monitor people and test for exactly which stage of the infection they are at.”
Dr Huygens, a respected molecular microbiologist based at the University of Queensland and the Translational Research Institute in Brisbane, helped found Microbio in 2017, with its platform technology designed to detect pathogens that cause sepsis.
In 2020, the company realised its technology could be adapted for use as a rapid COVID-19 test, and it’s been in development since.