Australians are being denied a chance to use a rapid antigen test approved by Britain’s health authority and issued free to millions of people over the past year, in a tussle over standards after a ban on the kits in the United States.
The test is produced by Xiamen Biotime Biotechnology of China and has been bought by the NHS in large volumes under contracts worth an estimated £3.7 billion for the product’s distributor as part of the British government’s “Operation Moonshot” bid for mass daily testing. The controversy centres on the US distributor of the kits, Innova Medical Group of California, which breached FDA standards last year by selling the tests without marketing approval, clearance, or authorisation from the peak US agency.“The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” it said.
Britain’s peak regulators, including a Health Security Agency and University of Oxford team, passed the Biotime test in September 2020 andLoading The Biotime kit was distributed in NHS packages to thousands of delegates to the United Nations climate summit in Glasgow in November, when Australians travelling with Prime Minister Scott Morrison used the tests each day and recorded the results with the NHS in order to gain entry to the summit.
“So, we’ve been working all through the Christmas and New Year period, looking at and approving RATs when we have the data.”have seen documents that confirm the Biotime kit is being considered by TGA officials.
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