A batch of nucleic acid reagent test kits have been approved with a medical device registration certificate, to help tackle the deadly novel coronavirus (2019-nCoV) outbreak.
These kits are said to shorten the detection time and recognise suspected cases more rapidly, especially latent infections. They work by using an automatic nucleic acid extractor and a mobile molecular diagnostic platform, and are claimed to generate test results within 30 minutes.
China’s National Medical Products Administration (NMPA) have approved three more for testing the coronavirus, with vaccines and treatments under development. The approved products include the reagent test kits mentioned and also a sequencing system of the virus, all designed to intensify the diagnosis process.
The NMPA have also urged other regulators to intensify the supervision of production to ensure product safety. Alongside the US Food and Drug Administration (FDA) and other regulators, the NMPA will continue to implement special approval procedures for drugs and devices to contain the outbreak.
Currently there are more than 20,000 cases of the coronavirus worldwide, with 427 deaths, almost all of them in mainland China.
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