According to the news of the National Health Commission on March 11, in order to further optimize the covid-19 virus detection strategy and serve the needs of epidemic prevention and control, after research, the comprehensive group of the State Council on the joint prevention and control mechanism for the new coronavirus pneumonia epidemic decided to add antigen detection as a supplement on the basis of nucleic acid detection, and organized and formulated the application scheme for covid-19 virus antigen detection (Trial).
It is mentioned that if community residents have self-test needs, they can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels.
China covid-19 antigen detection is released, and the applicable population is limited to three categories
In the interpretation of the National Health Commission’s plan, it is pointed out that nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. As a supplementary means, antigen detection can be used for screening of specific populations, which is conducive to improving the ability of “early detection”. If the primary medical and health institutions have the ability of nucleic acid detection, nucleic acid detection shall be the first choice; Those who do not have the ability of nucleic acid detection can carry out antigen detection, and do a good job in the training of medical personnel and the communication and guidance of patients.
The scheme stipulates the applicable groups for antigen detection: 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. At the same time, the main conditions to be met for antigen detection of the three groups and the access to detection reagents were clarified, and the disposal management process after positive detection was formulated to promote the connection between antigen detection and nucleic acid detection.
Relevant management departments (such as communities, villages and towns, isolation points, etc.) shall organize and manage the personnel in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area. During the isolation observation period, nucleic acid detection shall be carried out according to the requirements of the current relevant prevention and control plan, and antigen self-test shall be carried out once a day in the first five days.
a-share listed companies announce relevant progress
Beijing Hotgen Biotech Co.Ltd(688068) 11 day announcement, the company recently received the Singapore Health Science Bureau (HSA) approved COVID-19 antigen detection reagent, the product name is Beijing Beijing Hotgen Biotech Co.Ltd(688068) New Coronavirus 2019n-CoV antigen detection kit (anterior nasal cavity). After the product is approved by HSA certification, it can be sold in Singapore and countries and regions that recognize Singapore (HSA) certification.
Nanjing Vazyme Biotech Co.Ltd(688105) announcement, the New Coronavirus antigen detection kit developed by New Coronavirus, a wholly owned subsidiary of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd., has recently received the “medical device registration certificate” issued by the State Administration of drug supervision and Administration (note No.: Note No. 20223400346).
Sansure Biotech Inc(688289) said in response to investors’ questions on the interactive platform that the company has developed covid-19 virus antigen self-test kit and is currently applying for EU CE certification, US FDA certification and other relevant qualification certification. The company will continue to improve covid-19 epidemic prevention and control detection scheme, Actively promote the R & D and access of covid-19 antigen detection and other related new products.
Maccura Biotechnology Co.Ltd(300463) said in response to investors’ questions on the interactive platform that the company’s covid-19 antigen self-test product has been registered with TGA in Australia, and the registration of “home testing” European CE is being actively promoted.
Andon Health Co.Ltd(002432) said on the interactive platform that at present, the company’s covid-19 antigen detection kit products have been sold on ihealth’s official website in Hong Kong, which is the beginning of the company’s full support for Hong Kong’s epidemic prevention, and there are still many uncertain factors in the market. At present, the production and operation of the company is normal, and the contract and order are being earnestly fulfilled.
Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) said on the investor interaction platform that the company’s covid-19 antigen detection reagent can be used for home owned detection and sold in supermarkets, pharmacies and Internet stores in relevant countries that have been registered. Up to now, covid-19 antigen detection reagent (self-test version / medical version) of the company has obtained CE certification, and has successively obtained white list access in most countries in Europe and Southeast Asia. The company’s antigen detection reagents are mainly sold in Germany, France, Austria and other countries in Europe and Vietnam, Malaysia and other countries in Southeast Asia.
Contec Medical Systems Co.Ltd(300869) previously announced that the company’s covid-19 virus antigen detection kit (for professional use) was included in the list of medical material enterprises certified or registered with foreign standards, and the product has been allowed to be sold overseas.
Bgi Genomics Co.Ltd(300676) previously announced that the covid-19 antigen self-test product of BGI Europe a / s, a wholly-owned subsidiary of the company, has recently obtained the EU CE certificate.
And Zhejiang Orient Gene Biotech Co.Ltd(688298) said in the announcement of stock trading changes that up to now, the company’s covid-19 antigen detection reagent has not obtained the Chinese certification certificate, and the company will perform the obligation of announcement after obtaining the certificate.
how big is the investment outlet
Zheshang Securities Co.Ltd(601878) pointed out that compared with the current nucleic acid detection, on the one hand, antigen self-test can save the cost of nucleic acid detection instruments, sites and labor. At present, the price of covid-19 nucleic acid mixed test is still 20-40 yuan, which is significantly higher than the terminal price of antigen self-test Kit in the current European market; On the other hand, it helps to grade and divert covid-19 detection, avoid the waste of medical resources caused by the unified use of nucleic acid, and alleviate the shortage of testing resources in the scenario of centralized detection demand. In terms of promotion rhythm, it is expected that there may be a transition period in application, but it is expected to take the lead in pilot application or breakthrough in liberalizing approval and some scenes, groups or regions.
Zhongtai Securities Co.Ltd(600918) said that covid-19 antigen home self inspection is applicable to a wide range of general screening self inspection and is an effective supplement to nucleic acid detection. At present, covid-19 antigen self-test kits of hundreds of in vitro diagnostic manufacturers in China have been registered and approved overseas, and the market competition in Europe, Malaysia and other regions is becoming increasingly fierce. If the registration approval of covid-19 antigen self-test products in China is released, the head brands with complete and abundant clinical data and relatively large overseas sales may gain advantages. It is suggested to pay attention to Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Shenzhen Yhlo Biotech Co.Ltd(688575) , Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing Hotgen Biotech Co.Ltd(688068) , an Xu biology, etc.
Southwest Securities Co.Ltd(600369) the latest research report points out that in order to achieve effective prevention and control of covid-19 epidemic, covid-19 infection detection must be done well. At present, two detection paths are mainly formed based on molecular (genetic material) and Immunology (protein). At present, American CDC has taken covid-19 antigen detection combined with nucleic acid amplification technology as an important means of screening, and who and ECDC have also recognized the role of rapid antigen detection. If the follow-up epidemic is further influenza, more regions around the world are expected to receive antigen testing. It is estimated that the global market potential is expected to exceed 50 billion US dollars, of which the Chinese market is expected to reach 8.4 billion yuan.
