On the afternoon of March 15, the joint prevention and control mechanism of the State Council held a press conference. The press conference made a detailed interpretation of the neocoronavirus antigen testing products (self-test box) that are currently hot in the industry. Li Jinming, deputy director of the clinical testing center of the National Health Commission, pointed out that there are three main categories of "application groups of antigen testing": First, those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days; Second, isolate observers, including those in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area; Third, community residents who need antigen self-test. If the nucleic acid test of the first two types of personnel is negative, they can carry out antigen test at home for 5 consecutive days (self-test). The isolation observer shall conduct a nucleic acid test when releasing the isolation. If the antigen test is positive, do the nucleic acid test at the first time. Why continuous testing for 5 days? Experts pointed out that the virus content of people infected with coronavirus is relatively high one day in five days, so antigen detection can be done. If the antigen self-test continues to be negative, there is no need for any intervention. Jiao Yahui, director of the medical administration and medical administration of the National Health Commission, pointed out that the State Food and drug administration has approved the antigen detection reagent, and the antigen detection reagent will be approved in the follow-up meeting. Then through the way of online sales, sales will be more and more. Where to buy it? Major e-commerce platforms are pre-sale, and some are in stock According to the latest COVID-19 antigen detection application plan (Trial), community residents can purchase self testing antigen by self purchase by means of retail pharmacies, network sales platforms and other channels. Up to now, the FDA has successively approved 10 self-test products of new crown antigen, including Guangzhou Wanfu biology, Beijing jinwofu biology, Shenzhen Huada Yinyuan, Beijing huaketai biology, Nanjing nuovizan, Beijing rexing biology, Beijing Wantai, Beijing Lepu, Tianjin boosses and Chongqing Mingdao jietest. As of the closing on March 14, Wanfu biology's share price rose 3.71%, novozyme's share price rose 13.59%, and BGI's share price rose 9.98%. JD health, tmall, Alibaba pharmacy, Suning Tesco and other platforms have successively put on the shelves the new coronavirus antigen self-test kit, mainly for pre-sale: There is an appointment for sale; And have been put on the shelves. Among them, the hot scene biological antigen detection kit is available in stock in some regions and can be delivered in 72 hours, while the pre-sale period of jinwolff antigen detection kit is 10 days; For the pre-sale opened, the expected delivery time is March 20. Then open the pre-sale. ▲ summary of current product sales information ▲ Jingdong platform, jinwofu, BGI and Lepu are all on pre-sale In addition, major pharmacies, Dingdang express and meituan drug buying platforms have also successively launched pre-sale, and some areas are in stock. Major manufacturers also actively cooperate with channel providers for rapid distribution: Signed a strategic cooperation agreement with to become the core partner of the sales channel of rexing biological coronavirus antigen testing products. Cooperate with strategic partners to distribute and promote coronavirus antigen testing reagents through all channels. Previously, some areas also distributed self-test kits free of charge. For example, Xiamen, Tianjin and other places have distributed self inspection kits to home quarantine personnel free of charge. At present, the prices of various channels are uneven. At present, the self-test products of Xinguan are mostly below 30 yuan. Crazy antigen self-test has become a new driving force for IVD growth! Many of the ten products urgently certified have already crossed the ocean and have shown their skills abroad. For example, The new coronavirus antigen self-test kit products were approved by FDA in November 2021 and October 2021 respectively; The new coronavirus antigen self-test kit product has obtained EU CE certification. All these have effectively endorsed the reliability of the new crown self-test antigen detection kit. In terms of detection methods, there are three types of antigen detection approved for listing in China: Beijing jinwofu products are. The products of Huada Yinyuan and Beijing huaketai biology are, Wan Fu biology, Nanjing nuozan, Beijing Wantai, Beijing hot spot, Tianjin Bo OSSE, Chongqing Ming Dao Jie test, Beijing Le Pu company produced New Coronavirus antigen detection kit. At present, the self-test products of neocoronavirus antigen approved by FDA adopt colloidal gold technology. Europe, the United States, Japan, India and other countries have been vigorously promoting family self-help testing. The UK has been promoting rapid antigen detection since November 2020. After residents apply online, the detection reagent will be mailed. Last summer, the Biden government signed an agreement with Wal Mart, Kroger and, the two major retail giants in the United States, to sell the binaxnow test kit developed by Abbott at a low price of $14. After the low price sale agreement expired in December 2021, Wal Mart said it would raise the price to $19.98 and Kroger's price to $23.99. The price of ihealth test agent produced by Jiuan medical in China is only $6.99 on Amazon, an American e-commerce platform, but it has long been fully sold out. From January 15, the US government will officially implement the new crown rapid test plan. At the beginning of 2022, each American family can make an online reservation for four free kits to complete self-test at home. Policy promotion also provides performance incentives for manufacturers of coronavirus antigen testing. According to the financial report of 2021, the growth curve of molecular diagnosis, the main performance force of global IVD giants, began to decline in the past two years, while POCT business took over smoothly and completed a good growth relay. The rapid diagnosis business continues to rise sharply, which is regarded as the mainstay of Abbott diagnosis in the post epidemic era, contributing nearly $8.6 billion in revenue. CHF 2.6 billion (US $2.8 billion), a sharp increase of + 138% year-on-year, mainly due to the rapid antigen test of sars-cov-2. The high demand for rapid detection of COVID-19 antigens in Europe, the Middle East and Africa has contributed about 1 billion 80 million euros in revenue. Under China's current epidemic prevention policy, the release of Xinguan self-test reagent means that the epidemic prevention will transition from the "dominance" of nucleic acid detection to the hierarchical diagnosis stage of "nucleic acid detection as the main and antigen detection as the supplement". At present, the epidemic has entered a new stage of development, and the virus mutation has increased its infectivity, which is possible by continuous mutation. On the premise of strictly implementing the "clearing policy", the shortage of epidemic prevention personnel has become a hard injury. The implementation of graded diagnosis of "nucleic acid detection as the main and antigen detection as the supplement" may improve the efficiency of epidemic prevention. Antigen detection cannot replace nucleic acid detection At present, there are three main methods of new crown detection, namely nucleic acid detection, antigen detection and antibody detection. The detection mechanism, detection cost and detection sensitivity of the three methods are different. Based on the level of molecular biology, the virus infection state can be identified at the gene level by nucleic acid amplification in the early stage of virus infection. The detection has high sensitivity and specificity, but it has high requirements for sampling, operating environment, equipment and personnel, and the cost is high. It is through the oropharynx and nasopharyngeal swab sampling, through the N protein or S protein specific antibody and the COVID-19 carries N protein or S protein to produce the immunity reaction, carries on the immunity analysis through the colloidal gold, the fluorescence and so on markers, thus carries on the judgment to the virus. It is mostly used for early screening of diseases, with simple operation, rapid results and low cost. However, due to the difference of virus infection stage and sampling method, or the low virus content in the sample, false negative will occur. It mainly determines whether a person is infected with the virus by detecting antibodies that bind to the virus in the blood. Relatively speaking, the accuracy of antibody detection is low, but the difficulty of research and development is relatively small. At the beginning of the epidemic, the Wuhan virus Institute completed the development of the new coronavirus antibody kit within 72 hours, and the detection can be completed within 10 ~ 20 minutes. However, due to the low accuracy, there is a high probability of false positive and false negative, so it is only applicable to the rough statistics of the number and proportion of infections in a large number of infected areas, or as an auxiliary index of nucleic acid detection. It is worth noting that the results of antigen self-test cannot replace the results of nucleic acid test. At present, nucleic acid detection results are still the basis for the diagnosis of COVID-19 infection. Antigen detection as a supplementary means can be used for screening specific populations, improving the ability of "early detection", but not for "green code" endorsement. In this regard, Alibaba health, JD health and other e-commerce platforms have prompted this in the self-test section of neocoronavirus antigen. According to the press conference this afternoon, the sensitivity of nucleic acid detection is 100 to 1000 times higher than that of antigen detection. Li Jinming, deputy director of the clinical testing center of the National Health Commission, pointed out, "the specificity of antigen detection can reach 99%, but the specificity of nucleic acid detection in methodology is 100%. There is no false positive in nucleic acid detection in methodology, so nucleic acid detection has always been a basis and a 'gold standard' for us to determine new coronal infection. Therefore, antigen detection cannot replace nucleic acid detection. When the antigen test is positive, be sure to take nucleic acid test for confirmation. But if the nucleic acid test is positive, no matter whether the antigen test is negative or positive, the subject should take measures as a new coronavirus infected person or a confirmed patient. " epilogue It is reported that at present, many IVD enterprises whose products have been approved abroad but have not been listed in China are also actively applying for certificates, but the rapid volume of the market is often accompanied by the rapid upgrading of the regulatory threshold. In March 14th, the State Food and Drug Administration's Center for examination and approval issued the key points of the technical review of New Coronavirus antigen detection reagent registration (Trial), and clarified the relevant registration and evaluation standards of the new crown antigen reagent. According to the observation in the industry, the threshold of self-test registration of neocoronavirus antigen has been rapidly increased. However, according to the statement at today's press conference, "antigen detection reagents will be approved in the follow-up meeting". Next, these are the moments when manufacturers of self-test products with coronavirus antigen compete for speed. (Xinhua News Agency)