Australians have been warned of potential rapid antigen test (RAT) traps at some retailers selling unapproved kits.
The Department of Therapeutic Products has approved more than 30 different trials to meet national safety and efficacy requirements for use in Australia.
RATs that cannot pick up at least 80% of positive cases will not be approved.
“Unapproved versions may not work as expected or may not work at all,” medical regulators warned on Friday.
“(Unapproved RAT) has not been evaluated by the TGA, which means it does not have the same safety, efficacy and quality guarantees as those that meet Australian regulatory requirements.”
There is also growing concern about repackaging or relabeling tests that did not include all the components.
The warning occurs when tens of thousands of COVID-19 cases are still recorded nationwide.
The number of active cases in Western Australia exceeded 10,000 for the first time after the state recorded more than 2000 infections.
Prime Minister Mark Magawan reported 2289 new COVID-19 infections on Saturday, reaching 10,866 active cases and increasing virus hospitalizations by 7 to 28.
There were an additional 10,017 infections in New South Wales, 5721 in Victoria, 4152 in Queensland, 941 in Tasmania, and 696 in ACT.
During the latest reporting period, there were 10 more virus-related deaths in New South Wales, 24 in Victoria and 12 in Queensland.
On the other hand, anyone who tests positive for the virus and is quarantined in the event of a flood in New South Wales is urged to comply with evacuation orders.
COVID-positive people arriving at the relief center need to notify staff, wear masks and keep physical distance.