Chinese watchdog warns it’s on the lookout for fake Covid-19 RAT kits

Unauthorised products already on the market, says one approved test manufacturer
Five companies approved to make the rapid antigen tests for public use

Coronavirus pandemic

Amanda Lee

Published: 9:00pm, 13 Mar 2022

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China’s medical products watchdog has warned that it will be on the lookout for unauthorised at-home coronavirus tests as the country grapples with its worst Covid-19 outbreak in nearly two years.

A day after health authorities approved rapid antigen tests for general use, the National Medical Products Administration said it would step up monitoring of the kits.

“[The administration will] severely crack down on violations of laws and regulations … on unauthorised production and operation of unregistered new coronavirus antigen detection tests,” it said on Saturday.

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Unlike many other countries where the kits are widely used, China had not allowed them to be commercially available to the public.

Then on Friday the National Health Commission said anybody could use them for early detection of the coronavirus.

Five Chinese companies have approval to make the tests: Beijing Huaketai Biotechnology, Nanjing Vazyme Biotech, Guangzhou Wondfo Biotech, Beijing Jinwofu Bioengineering Technology and a BGI Genomics subsidiary, Shenzhen Huada Yinyuan Pharmaceutical Technology.

A number of retail pharmacies, including the Shanghai-listed LBX Pharmacy Chain, have said they will soon start selling the kits in stores and online.

LBX said on Saturday that it had an agreement with Wondfo Biotech to sell the company’s Covid-19 antigen kits in its stores in 12 regions, including Shanghai and the provinces of Hunan and Jiangsu.

The first batch of kits were already in transit and expected to be on sale in stores “in the near future”, the chain said on its WeChat social media account.

LBX Pharmacy Chain says it has an agreement with Wondfo Biotech to sell kits. Photo: Handout

But quality and safety problems have plagued China’s food and drug industry.

Wondfo Biotech said on Saturday that it had found “unauthorised” sales and promotion of its Covid-19 kits online.

“The company reserves the right to report the cases to the relevant public security department and investigate the corresponding legal responsibilities,” it said.

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The approval of the kits comes after Premier Li Keqiang said the country’s zero-Covid response would be fine-tuned to minimise disruptions to the economy.

Chongqing Medical University president Huang Ailong has also pushed for the tests to be deployed.

According to state-run China News Service, Huang, a member of the Chinese People’s Political Consultative Conference, said last week that China should consider combining large-scale rapid at-home tests and targeted small-scale nucleic acid detection programmes.

Huang cited efforts in Bishan district in Chongqing, where the rapid tests proved effective in early detection of the coronavirus.

“[The programme] further verifies that the use of rapid antigen detection for large-scale early screening has many advantages and can be widely promoted,” Huang was quoted as saying.

“The combination of the two can greatly improve the efficiency, the cost, reduce the restrictions and impact on economic development caused by epidemic prevention and control.”