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Five COVID-19 antigen kits get approval in China

COVID-19 antigen kits approved in China

SHANGHAI: China has granted approval to five COVID-19 antigen kits made by local companies to be used for self-testing, state broadcaster CCTV said on Saturday, as it tweaks its testing regime that has been pressured by Omicron.

China’s National Medical Products Administration (NMPA) published a notice on Friday saying Beijing Huaketai Biotechnology had been allowed to make changes to its COVID-19 antigen test kit’s device certificate.

It published a similar approval for four other companies, Nanjing Vazyme Biotech, Guangzhou Wondfo Biotech, Beijing Jinwofu Bioengineering Technology and a BGI Genomics subsidiary, Shenzhen Huada Yinyuan Pharmaceutical Technology, on Saturday.

While the NMPA did not provide more information, CCTV said the NMPA approvals marked the official market launch of new COVID-19 antigen self-test kits.

The approvals come after the country’s health regulator on Friday said it would allow the general public to buy COVID-19 antigen self-test kits in stores and online for the first time.

In the past two years, medical workers in many Chinese cities have swabbed hundreds of thousands of noses and throats within days after just a handful of cases emerged, using nucleic acid tests that require labs to process samples. The scale of effort has helped China keep its caseload tiny by global standards.

However, some experts said it has become increasingly challenging for that strategy to keep up with the spread of the Omicron variant. China’s daily rise of domestically transmitted cases reached a two-year high this week with many asymptomatic carriers.



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