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3rd February 2020  Editorial by: Paul Carton

China Approves Sansure Biotech's 2019-nCoV 30-Minute Nucleic Acid Reagent Kit 


China's first coronavirus nucleic acid diagnostic kit, to be certified by the Chinese Food and Drug Administration (CFDA) has been approved by the National Medical Products Administration (NMPA) to detect 2019-nCoV in suspected cases.

The Sansure Biotech 2019-nCoV nucleic acid diagnostic kit (PCR-Fluorescent Probe) has a turnaround time of 30 mins from test to result. This RNA-based one-tube technology mobile platform comes equipped with an automatic nucleic acid extractor and can shorten detection time and recognize suspected cases, especially latent infections. 

The NMPA approved four products in total on the 26th of January. The products, including reagent test kits and a sequencing system of the virus, are expected to speed up the diagnosis process and further expand the supply capacity of virus detection products.

Meanwhile, the NMPA urged provincial drug regulators to intensify the supervision of production to ensure product safety.

The administration said it would continue implementing special approval procedures for drugs and medical devices to contain the outbreak.


    

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Date Published: 3rd February 2020

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