Administration of Medicinal Products revokes approvals and fines after review shows that many kits may not measure up to marketing hype
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A number of unreliable Covid 19 antibody rapid tests have been put on the Australian market by health authorities. They have rescinded licenses, levied penalties, and vowed to prosecute a manufacturer that sold an unapproved product. Very little scrutiny has been given to the vast quantities of fast tests that reached the Australian market in the early stages of the pandemic. In most cases, manufacturers reported that Covid 19 antibodies with more than 90 percent accuracy could be identified by their products. Australia coronavirus news live: Morrison says vaccinations will start mid-to late-February as Queensland quarantine worker tests positiveRead moreA Doherty Institute study has now analyzed 15 of the market kits and released the findings in a series of re-tests One test kit from GenBody Inc. of South Korea had an accuracy of just 38.5 percent, rising to 58.5 percent 14 days after symptoms appeared, and another had an accuracy of just 39 percent from China’s Innovita (Tangshan) Biological Technology Co Ltd. The results prompted the Administration of Therapeutic Goods to cancel approvals for three rapid-test products listed in the Therapeutic Goods Registry of Australia, halting their sales. The most recent cancellation, released on Dec. 2, included a kit developed by the South Korean company PCL Inc. that reported that its system had an accuracy of 81.35 percent, which improved to almost 100 percent two weeks after the onset of symptoms. The analysis by the Doherty Institute found that the two figures were 48 percent and 50 percent, respectively. That business still offered the devices for sale on Wednesday, saying that they had “100 percent ” accuracy, more than a month after they were de-listed by the TGA. It claimed that it questioned the validity of the data used by the TGA and asked the regulator to delay the cancellation until it could hear its objections. “We have asked the TGA to defer cancellation of our registration until our objections have been evaluated, as we have good scientific reasons to support the fact that the results are inaccurate,” Jim Manolios, chief executive of the company, said in an email. Just before Christmas, the TGA denied our application, which is why the antibody test in question is still on our website. Our website manager is in the process of removing the product in question before we obtain further input from the Health Department and finally the TGA. A further nine Covid 19 rapid test suppliers, including GenBody and Innovita, have withdrawn their products fro fro. Two weeks ago, the TGA fined Brisbane-based PPE Direct $13,320 for allegedly inappropriately advertising a Covid 19 rapid test kit for allegedly claiming that a Covid 19 rapid test kit was endorsed by a government or government agency on the Infinity Biotech website.” PPE Direct, doing business as Infinity Biotech, said on its website as recently as Wednesday that its Covid-19 test was Australia’s “f
It purchased them in bulk, including 500,000 from Promedical, which is run by a convicted rapist, based in Brisbane, and 1 million from Onsite and VivaDiag, which later turned out to be much less precise than originally believed. Rapid antibody tests are not used to detect current Covid-19-19 cases.