Multiple enterprises have arranged, with daily production of 773000 kits, and 7 products have passed emergency approval

Authors: Linan 7 novel coronavirus nucleic acid reagents were issued by the State Administration of pharmaceutical supervision and quarantine in January 26th The State Administration of pharmacy and Quarantine issued a document that the new coronavirus nucleic acid reagents for emergency examination and approval were fully approved to serve the epidemic prevention and control The novel coronavirus has been tested by 4 enterprises, according to the content Since then, the novel coronavirus kits were approved by the State Administration of drug administration on 28 and 31 days respectively They are the Chinese big genes, the Shanghai River, Shanghai's Genso, Sheng Xiang biology, Da'an gene and Shanghai Berger medical treatment As of 31 novel coronavirus nucleic acid test reagents were approved by 6 of the 6 enterprises The State Food and Drug Administration said it would continue to do a good job in emergency approval of corresponding products according to the needs of epidemic prevention and control Novel coronavirus reagents for emergency examination and approval According to relevant reports, the new coronavirus kit, which is related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids, belongs to the third category of in vitro diagnostic reagents according to national regulations, that is, the highest level of review in medical devices, which needs to be reviewed by the State Food and drug administration, so the review process is also tedious and long Analysts pointed out that according to the conventional process, it will take 2-3 years of clinical trials for in vitro molecular diagnosis products to enter the hospital market This time, the State Food and Drug Administration opened up a green channel, and it took only 4 days to complete the process Industry insiders pointed out that in the past, the validity period of such certificates was generally 5 years, but the validity period of the registration certificates approved by the State Food and drug administration was 1 year The registration information also stressed that the product is only for the auxiliary diagnosis and emergency reserve of pneumonia infected by new coronavirus In addition, the enterprise should complete all registration application materials in accordance with the requirements of the administrative measures for registration of medical devices Etc On the other hand, after passing the emergency approval, BGI, Shengxiang biology, Da'an gene, etc are trying to expand production and ensure market supply For example, the novel coronavirus detection kit has been completed in about 300 thousand people recently It has greatly relieved the supply pressure of the kit, and has reached 80 thousand people per day Meanwhile, it has continued to arrange 300 thousand more people to produce 300 thousand kits and 300 thousand new kit The novel coronavirus nucleic acid reagents can reach the maximum daily capacity of 500 thousand people The Da gene has been revealed recently, and the kit can produce 110 minutes, and it can produce 200 thousand people per day The following up to 500 thousand people per day, the core raw materials are Da'an gene itself Mastery The head of the company said he was ready to go all out to ensure the market supply, and the company's production capacity was fully able to meet the market demand A novel coronavirus genome sequence was detected and grandpa released in January 10th The novel coronavirus novel coronavirus genome was first published in January 26th, and the publication of the viral genome sequence was the window for the development of the new coronavirus nucleic acid detection kit Novel coronavirus nucleic acid reagents novel coronavirus are developed in the world In addition to the above, many countries are developing new coronavirus nucleic acid reagents, which are as follows: Based on the technology of fluorescent PCR, the new coronavirus nucleic acid detection kit and coronavirus pass nucleic acid detection kit were developed in January 13, 2020 In January 28th, the novel coronavirus reagents for inspection of the world biological products were tested at all items of the Jiangsu medical equipment inspection institute, and met the technical requirements of the products Become the first novel coronavirus detection reagent for Jiangsu statutory inspection institutions Hot spot biology to novel coronavirus pneumonia epidemic situation, hot spot biology "lab" started research and development in January 15th, completed nucleic acid reagents research and development on 20, began 21 days to start gene recombinant protein expression, 22 days began to develop immune reagents, 30 days of immune fast reagent and enzyme exemption agent successively developed successfully, now has developed three detection kit for the virus The novel coronavirus novel coronavirus detection kit developed by Shandong AIKE Wei Biotechnology Co., Ltd in January 27th, has been tested by the provincial instrument inspection center and has become the first new coronavirus detection product approved by Shandong statutory inspection agency The novel coronavirus will be sent to hospitals around the country to obtain new coronavirus in suspected samples At present, the company has started the emergency recovery production plan, and the order can guarantee the supply Dean has recently completed novel coronavirus series testing reagent development The product is a novel coronavirus nucleic acid detection kit based on fluorescent PCR platform It has been completed in the Zhejiang medical device research institute's registration test, and is expected to provide accurate detection products for the market soon The novel coronavirus novel coronavirus detection kit developed by the company, the fluorescence PCR method and the new rapid detection kit for coronavirus protein (immunochromatography) are in clinical verification stage The company said that after the verification results meet the relevant test standards, it will submit samples and relevant information to the State Drug Administration for registration The novel coronavirus series reagent has been completed recently The products include novel coronavirus novel coronavirus antigen detection reagent, antibody detection reagent based on colloidal gold immunochromatography, and a new 2019-nCoV coronavirus nucleic acid detection kit based on fluorescence PCR platform 2019-nCoV At present, some products have completed the sampling of registered products, and the company is expected to provide the market with a series of products for on-site rapid detection and precise detection soon Panoramic life A novel coronavirus detection product has been developed recently The product uses a card fluorescent PCR method All PCR extraction, preparation and amplification are all reduced to a card box After the sample is added to the cartridge, the detection process is completely closed, and the possible cross contamination and risk of transmission of disease are controlled in the card case 。 The product can be sampled randomly, and can be tested in the bedside or other open laboratories immediately, and the results can be obtained after 1-1.5 hours At present, the company is organizing personnel to carry out clinical verification and registration application of products The novel coronavirus gene detection kit (fluorescent PCR method) has been successfully developed by Ed bio It is simple, convenient and accurate It can get the test results within 2 hours, and is applying for the emergency examination and approval channel opened by the State Administration of Drug Administration for the epidemic A novel coronavirus infection test reagent has been developed by the Jiaxing medical laboratories, Jiaxing, the Medical Laboratory of the medical center The novel coronavirus rapid detection kit was developed by team in collaboration with the technical team of Beijing and Jiaxing Next, through the clinical trial, registration and approval process, the team can produce mass production The novel coronavirus novel coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) and a new coronavirus (2019-nCoV) IgM antibody detection kit have been developed by Hong Wah bio Weifang Biotechnology Co., Ltd recently (IgM) The product passed the national registration inspection for the first time on January 31, 2020 At present, it is applying to the State Food and Drug Administration for emergency approval After obtaining the registration certificate, it can be put into the market for sale After mass production, the reagent can reach 500000 people per day Berry gene recently, novel coronavirus nucleic acid detection group of Berry gene announced that the new coronavirus 2019-nCoV nucleic acid mutation detection kit (single molecule sequencing method) was successfully developed Based on the third generation single molecule sequencing technology platform, the kit can effectively detect the nucleic acid sequence variation of new coronavirus, timely grasp the virus variation dynamics, improve the detection sensitivity, and reduce the "false negative rate" caused by virus variation in virus nucleic acid detection The novel coronavirus nucleic acid reagents have reached 773 thousand people daily Novel coronavirus novel coronavirus nucleic acid reagents were released in February 3rd According to Guangming Daily News, in February 3rd, the State Council held a press conference on the joint prevention and joint control mechanism of the new coronavirus infection Tian Yulong, the Party member and chief engineer of the Ministry of industry and information technology, said that by February 1st, the daily output of the new coronavirus nucleic acid reagents has reached 773 thousand people, which is equivalent to that of the suspected cases , has basically met the requirements Tian Yulong pointed out that with regard to the problem of detection reagents, nucleic acid detection reagents are a very mature means of detection of infectious diseases At present, it is the health system and hospitals that directly purchase from enterprises Theoretically, this kit should not be guaranteed Of course, there are some small difficulties due to the problems of early time and resumption of production But for now, capacity has recovered By February 1, our daily output had reached 773000, 40 times that of the suspected patients From the perspective of total supply, it has basically met the requirements Of course, the production capacity has not been fully restored, only reaching 67%, and the subsequent work is mainly to restore production capacity Guangzheng Hengsheng pointed out that in the short term, for in vitro diagnostic kits enterprises, on the one hand, the surge of testing just needs to bring direct performance and growth to some of the first enterprises to be approved, on the other hand, for enterprises to be approved, enterprises with strong R & D and certification ability are expected to take a share, in addition, such enterprises should ensure product quality while striving to obtain certificates as soon as possible In any case, the quality of the product is crucial In addition, combined with the current published output, the difference between products, such as who can diagnose more accurately and produce faster results, is the king Jeni turtle