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    Home > Active Ingredient News > Drugs Articles > 10 new coronavirus detection kits have been approved

    10 new coronavirus detection kits have been approved

    • Last Update: 2020-02-24
    • Source: Internet
    • Author: User
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    In February 22nd, novel coronavirus novel coronavirus products were detected in 3 enterprises, including 2 colloidal gold antibody detection reagents and 1 isothermal amplification chip nucleic acid reagents, and expanded the detection methods and means of new coronavirus, and fully serve the epidemic prevention and control needs, the State Administration of Drug Supervision issued a document, which said that in February 22nd, the State Administration of Drug Administration issued a document The 3 novel coronavirus antibodies were novel coronavirus fast detection reagent, 2019- new coronavirus IgM/IgG joint detection kit (colloidal gold method), Boao biological constant temperature amplification chip nucleic acid detection agent The novel coronavirus nucleic acid reagents were approved by the State Administration of drug supervision and quarantine through 7 emergency approvals Up to now, a total of 10 new coronavirus detection kits have been approved for marketing through the "emergency channel" The production enterprises involve Huada gene, Shanghai Zhijiang, Shanghai Jienuo, Shengxiang biology, Da'an gene and Shanghai Berger medical Subsequently, novel coronavirus (2019-nCoV) antibody test kit (colloidal gold method) was released by the government The novel coronavirus assay (novel coronavirus pneumonia) (IgM/IgG) antibody is a simple and easy method It can be used to detect the new type of coronavirus (2019-nCoV) antibody in human serum, plasma and whole blood samples in vitro The operation is simple and can be read in 15 minutes The antibodies of novel coronavirus include IgM and IgG Positive IgM antibody indicates a recent infection, while positive IgG antibody indicates a long time of infection or a previous infection According to the relevant person in charge of Wanfu biology, the kit can detect IgG and IgM antibodies at the same time, which can be more effective for the evaluation of suspected cases; it can break through the limitations of the existing detection technology on the site and operators, and can be used as a supplement or coordination of nucleic acid detection, widely used in medical and health institutions at all levels, to promote the forward and downward diagnosis Another constant temperature amplification chip nucleic acid detection reagent, it is reported that under the guidance of academician Zhong Nanshan, head of the high-level expert group of the national health and Health Commission, and Academician Li Lanjuan, high-level expert of the national health and Health Commission, the new microfluidic chip system for the detection of respiratory tract multi virus is jointly designed and developed by Boao biological Group Co., Ltd., Tsinghua University and West China Hospital of Sichuan University Unification The novel coronavirus, influenza A virus, new influenza A (H1N1) virus (2009), influenza A (H3N2), influenza B virus and respiratory syncytial virus can be detected in 6 hours in 1.5 hours At present, the product has obtained 15 authorized patents and 7 various science and technology awards Novel coronavirus nucleic acid detection novel coronavirus products were approved by the State Administration of drug safety for the purpose of detecting RT-PCR The novel coronavirus nucleic acid detection novel coronavirus pneumonia, which is the only clinical approved multi index nucleic acid detection product, can not only help medical personnel quickly distinguish between normal persons and new coronavirus infected patients, but also effectively identify influenza patients and new crown pneumonia patients, so as to achieve accurate diagnosis and precise treatment for patients It can be seen that the time for the new test products to produce results is significantly shorter than that of the previous test products, and the test results are more accurate The State Food and Drug Administration pointed out that it will continue to do a good job in emergency approval of corresponding products according to the development of the epidemic situation.
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