Health authorities have cracked down on a number of wildly inaccurate rapid Covid-19 antibody test kits being pushed on to the Australian market, cancelling approvals, issuing fines and pledging to investigate one supplier marketing an unapproved device.
Relatively little scrutiny was applied to the large volumes of rapid test kits that were rushed on to the Australian market in the pandemic’s early stages.
The kits promised to detect antibodies and return results within 15 minutes, without the need for laboratory testing.
In most cases, manufacturers claimed their products could detect Covid-19 antibodies with more than 90% accuracy.
A review by the Doherty Institute has now analysed 15 of the kits on the market, publishing its results in a series of reports last year.
The institute found the accuracy of many tests fell well short of their claims.
One kit produced by the South Korean firm GenBody Inc was found to have an accuracy of just 38.5%, which rose to 58.5% 14 days after the onset of symptoms.
Another kit produced by the Chinese company Innovita (Tangshan) Biological Technology Co Ltd was found to have an accuracy of just 39.4%, which improved to 56.9% a fortnight after symptoms.
The findings have prompted the Therapeutic Goods Administration to cancel approvals for three rapid testing products listed on the Australian Register of Therapeutic Goods, effectively stopping their sale.
The most recent cancellation, issued on 2 December, was for a kit manufactured by South Korean company PCL Inc, which had claimed its device had an accuracy of 81.35%, improving to almost 100% a fortnight after the onset of symptoms.
The Doherty Institute review found the two figures were 48% and 50% respectively.
The PCL tests are being supplied in Australia by Haemokinesis Pty Ltd. That company was still marketing the devices for sale on Wednesday, claiming they had “100%” accuracy, more than a month after the TGA cancelled the listing.
When approached by Guardian Australia, Haemokinesis said it would remove the material from its website.
It said it was challenging the validity of the data used by the TGA and had asked the regulator to delay the cancellation until its objections could be heard.
“We requested the TGA hold off cancelling our registration until our objection was evaluated as we have sound scientific reasons to support the fact the results are inaccurate,” Jim Manolios, the company’s chief executive, said in an email. “The TGA rejected our request just before Christmas which is why our website still features the antibody test in question.
“Our website manager is in the process of removing the product in question until we have further feedback from the Department of Health and ultimately the TGA.”
The TGA told Guardian Australia it would investigate the Haemokinesis website and take action if it was found to be marketing a product not listed on the register.
Another nine suppliers of rapid Covid-19 tests, including GenBody and Innovita, have removed their products from the register following regulatory action, while 13 companies have updated the data they are using to sell their goods following the TGA’s intervention.
A spokesman for the TGA said: “Where appropriate, based on our reviews, some sponsors have been required to amend their Instructions for Use, a number of sponsors have voluntarily cancelled their ARTG entries and others were cancelled by the secretary of the department.”
Two weeks ago the TGA fined the Brisbane-based company PPE Direct $13,320 for the alleged unlawful advertising of a Covid-19 rapid test kit because it “allegedly implied, on the Infinity Biotech website, that a Covid-19 Rapid Test kit has been endorsed by a government or government authority”.
PPE Direct, which trades as Infinity Biotech, still claimed on its website as recently as Wednesday that its Covid-19 test is “Australia’s First TGA-Listed Coronavirus Rapid Test”. The company was approached for a response.
Initially, the Australian government was hopeful it could use rapid antibody tests as part of its Covid-19 response. It bought them in huge numbers, including 500,000 from the Brisbane company Promedical, headed by a convicted rapist, and 1m from companies Onsite and VivaDiag, which later turned out to be much less accurate than initially thought.
Rapid antibody tests are not being used to detect current cases of Covid-19 because of the concerns about their accuracy and reliability.
The Doherty Institute says they may have some future use for population-level surveillance, and many manufacturers are at pains to point out that they never said the rapid tests should be used on their own, or relied upon as a sole determinant of Covid-19 cases.
