China's first Chikungunya virus detection product for market release has been approved by top regulatory authorities, according to the drug administration authorities in Guangdong province.
The Chikungunya virus nucleic acid detection kit, developed by DaAn Gene Co, based in Guangzhou, the provincial capital of Guangdong, received approval from the National Medical Products Administration on Thursday for distribution in the market.
The detection kit is used for the in vitro qualitative detection of Chikungunya virus nucleic acid in serum samples from suspected Chikungunya fever cases and others requiring diagnosis or differential diagnosis of Chikungunya infection.
Drug administration authorities in Guangdong will coordinate with the company to fully organize production preparations and strengthen post-market regulation of the product.
The company said production and clinical use would begin within a week of receiving the certificate, with the maximum daily production capacity adjustable to meet demand, potentially reaching 10 million tests per day within a month to ensure the needs of epidemic control.
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