The TGA has approved Brisbane company Elamaan Health’s EasyNAT COVID-19 RNA test, and it will be available for sale by November 1.
The company said the hand-held self-test kit can detect all strains of COVID-19, including omicron, and that tests will deliver results in around 55 minutes.
“It’s the first to be introduced into Australia as a portable PCR test,” Elamaan Health consultant Dr Roy Hardman said.
He said the battery-powered processing kit requires a nasal swab and produces results with “99 per cent accuracy, very similar to a laboratory PCR test”.
The test itself looks like a rapid antigen test, but unlike RATs it’s a nucleic acid test and detects the presence of viral RNA to diagnose COVID-19.
But pathologists say people should be very cautious.
They say despite the test using molecular technology, it is not a PCR test and is yet to be tested globally.
“They’re not going to be as sensitive as a laboratory PCR test which massively amplifies any RNA that’s present,” Dr Lyn Waring, the Royal College of Pathologists’ Microbiology Chair, said.
“We need to hold back a little, wait to see how they perform.
“We just need to know, people at high risk, they need to know if they’re infected early so they can get treatment early.”
Experts say the test is likely to be more sensitive than a RAT, but it will not be as sensitive as a lab-based PCR.
There will also be the same quality control issues as RATs – you can’t always be sure someone is using them accurately, whereas PCR lab tests undergo rigorous checks.
“Currently there are assessments being done across Australia, both in government and private organisations,” Hardman said.
Elamaan Health is targeting emergency service workers, fly in, fly out workers, aviation staff and the travel industry with its tests.
A single-use kit will cost about $55 and will need to be stored in the fridge.