The federal government has quietly agreed to allow the importation of unapproved rapid antigen tests for personal use amid shortages of approved kits.
Even the kits approved by the Therapeutic Goods Administration have varying degrees of accuracy, and the TGA is currently reviewing the effectiveness of the 23 tests approved for detecting Omicron. Low sensitivity on tests could mean people receive negative results even though they are infectious, and go on to spread the virus.
The agriculture, water and the environment department’s website was updated on 12 January with new rules for imported tests. Up to three months’ supply of the unapproved tests can be brought into the country as long as they meet various conditions including “does not contain bee pollen”, and are commercially prepared and packaged for testing humans.
The relative accuracy of the tests is not mentioned. The TGA said individuals can legally import therapeutic goods but if they are not approved for supply within Australia there are “no guarantees about their performance or quality”.
It advises that when buying home tests, “only tests that are approved by the TGA should be bought”.
“The TGA cannot vouch for the effectiveness of unapproved products,” a spokesperson said.
The Australian Medical Association vice-president Chris Moy said people importing their own unapproved tests was a symptom of “frustration” over the “chaotic” rollout of the tests, and it went against earlier statements from the government about the relative accuracy of them.
“We have had such a chaotic implementation in terms of access, equity, use and advice on how to use them. The bottom line is this is just a symptom of the mess, the lack of pre-planning at both a federal and state level in terms of a strategy and plan to access and use RATs across the board,” he said.
According to the department’s website, RAT kits do not need an import permit if they are approved by the Therapeutic Goods Administration, or if they are unapproved but for personal use.
“Personal use only includes: a three-month supply for use by the person importing the goods; or for use by any spouse, de facto partner, child, parent or sibling of the person importing the goods,” the website states.
“Note personal consignments of Covid-19 RAT kits that are not approved for supply in Australia by the TGA (ie listed on the ARTG) may be referred to the TGA for assessment upon arrival in Australia.”
Moy said it was “so inconsistent” to bring the tests in. “We had this idea we had to have them TGA approved, with fines for not reporting results, and now it’s just a free for all,” he said.
The government had minimised the usefulness of RATs, Moy said, until they needed them to back up the “overrun” PCR system, to keep workplaces going, and to help people work out their chances of being infectious.
“It was downplayed as an idea that they were for personal use, a though it’s a luxury,” he said.
The TGA said rapid antigen test results were unreliable when there was low community transmission, because there would be many false positives, but that has changed as the virus has spread and positives are more likely to be real results.
“It is self evident that they would be helpful for people to determine whether they’re likely to be infectious, to determine their personal responsibility.”
The Australian federal police and the TGA are investigating forged documents that have allegedly been used to import and sell RATs. It is still illegal to sell RATs imported for personal use.
However, Dean Whiting, the chief executive of Pathology Technology Australia, said a “grey market” of Covid products was emerging.
“We’re now becoming aware of a grey market in Australia for all sorts of products,” he said.
Whiting added that on a reputable test, the instructions include advice on contacting state health authorities to notify them in the case of a public test.
“But if a product is coming in without the current instructions, then people who test positive don’t know who to contact and we might have people out in the community who haven’t followed up on their results,” he said.
People should stick with reputable, known brands, he said.
The TGA said anyone testing positive must still “report the positive result to the appropriate state or territory health department and follow the public health order for their state or territory”.
