New coronavirus test kit has been approved by several listed companies to expand production

Since the State Drug Administration launched the emergency approval procedure for medical devices, many test kits have "swarmed out" A novel coronavirus detection kit has been successfully developed by nearly 100 enterprises, according to incomplete statistics from Shanghai Securities Daily The novel coronavirus 2019-nCoV nucleic acid detection kit registered by 7 enterprises has been approved by the State Administration of drug administration In order to ensure the supply of kits, listed companies have said they are stepping up production capacity A novel coronavirus 2019-nCoV nucleic acid detection kit has been approved for sale, reaching 7 The novel coronavirus detection kit for the Chinese big gene is the first batch of products that are approved to be listed for the fight against epidemic diseases At the same time, the dnbseq-t7 sequencing system of Huada Intelligent Manufacturing Co., Ltd also passed the emergency approval in the same batch The novel coronavirus is a high throughput sequencing instrument It can complete the whole detection process of the new coronavirus within 20 hours, and the detection flux can reach 200 per running sample On the afternoon of February 5, the "eye of fire" laboratory jointly built by Wuhan municipal government, Donghu high tech Zone, CCCC Second Harbor Engineering Bureau, Shanghai norui laboratory and BGI was officially put into trial operation It is reported that the core experimental area of the "eye of fire" laboratory covers a total area of 1000 square meters In strict accordance with the design of P2 (biosafety level II) laboratory, it is equipped with the overall high-throughput sequencing solution and equipment of huadazhi, 30 B2 level biosafety cabinets, 12 automatic extraction equipment for batch automatic nucleic acid extraction platform, and the designed detection flux is 10000 people per day The 2019 novel coronavirus novel coronavirus detection kit was developed by the Shanghai medical device inspection institute in January 24th It has become the first new coronavirus detection product approved by the statutory inspection institution in China On January 26, the above products passed the examination and approval of the State Drug Administration At the same time, in order to improve the detection accuracy, Zhijiang biology has developed a fully automatic closed detection platform, which can operate on its own only by putting samples into the instrument Da'an gene revealed on the interactive platform that the standard daily production capacity of the kit has reached 200000 According to the market demand, the production capacity can reach more than 500000 The core raw material technology is mastered and independently produced by the company itself Meanwhile, the novel coronavirus 2019-nCoVIgG antibody and IgM antibody detection kit of "colloidal gold" and "ELISA" have been successfully developed by the company's controlling subsidiary, Guangzhou Dali biotech Limited by Share Ltd In addition, the nucleic acid test kits of Shanghai Jienuo Biotechnology Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd., Shanghai Bojie Medical Technology Co., Ltd and other enterprises under the State Pharmaceutical Group have been approved and listed by the drug administration Novel coronavirus pneumonia novel coronavirus pneumonia is still the main diagnostic basis Why is it diagnosed that the new crown pneumonia is diagnosed by nucleic acid detection? The reporter learned that novel coronavirus pneumonia is currently diagnosed in the field The common methods of molecular biology are viral gene sequencing and nucleic acid detection Because gene detection has high requirements for equipment, bioinformatics team, cost and detection cycle, the current diagnostic methods are mainly nucleic acid detection As for the false negative phenomenon of nucleic acid detection in recent reports, relevant industry people told reporters that the main influencing factor is the sampling site The accuracy of alveoli and sputum is the highest, but it is difficult to obtain Nucleic acid detection is still the only means of diagnosis, as long as the test is positive, it is the diagnosis The novel coronavirus was only diagnosed as an auxiliary diagnostic and emergency reserve for pneumonia caused by new coronavirus, and the validity period is 1 years Clinical data shall be supplemented when continuing registration On the afternoon of February 8, Jiang Deyuan, inspector of the equipment registration department of the State Food and drug administration, said that he would continue to do a good job in emergency approval of medical devices according to the needs of epidemic prevention and control Especially for new coronavirus rapid detection reagents, once there are mature products, they will continue to be included in the emergency approval process for evaluation and review.