Beijing is stepping up its oversight of exports of coronavirus test kits after several European countries complained about the accuracy of some Chinese-made tests.
FILE PHOTO: Reuters reporter Brenda Goh receives a nucleic acid test for COVID-19 in Wuhan, Hubei province, the epicenter of China's coronavirus disease outbreak, March 28, 2020. REUTERS/Aly Song/File Photo
Some Chinese test kit makers had been taking advantage of easier European Union regulations to get their products into the market before they were approved at home. Spain withdrew a batch of rapid tests manufactured by Chinese diagnostics firm Shenzhen Bioeasy Biotechnology after the product was found to have low sensitivity, which means they were unable to detect infection sufficiently.
The preliminary conclusion from the Chinese consulate in Slovakia was that the inaccuracies were the result of medical workers using the kit incorrectly, the spokeswoman said.Bioeasy’s rapid tests, as well as the tests questioned by Slovak officials, are antigen tests, a method that targets the virus’ protein to detect infection and can deliver results more quickly than the alternative nucleic acid method.
A stricter rule will come into force in 2022 that will require many infectious disease diagnostic product manufacturers to follow procedures that can take up to a year or more to get a CE mark that indicates approval to be legally sold in European countries. “Our reagents don’t have certificate and cannot be exported,” the company’s marketing director Feng Zhenzhen said, adding the firm is “actively” applying for Chinese regulator’s approval.
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