On the 11th, with the announcement of the application scheme for covid-19 virus antigen detection (Trial), "residents can purchase reagents to self test covid-19 virus antigen" attracted great attention. Some analysts believe that this means that nucleic acid testing will no longer dominate in China's covid-19 virus testing market in the future.
Why should China promote antigen testing? What are its advantages? How big is its potential market?
Source: screenshot of the official website of the National Health Commission
residents can purchase antigen detection reagents by themselves
On November 11, the official website of the National Health Commission announced that in order to further optimize the covid-19 virus detection strategy, according to the needs of epidemic prevention and control, the comprehensive group of the joint prevention and control mechanism of the State Council decided to promote the monitoring mode of "antigen screening and nucleic acid diagnosis" and add antigen detection as a supplement to nucleic acid detection.
The application plan for covid-19 virus antigen detection (Trial) formulated and issued by the comprehensive group of joint prevention and control mechanism of the State Council stipulates three categories of people applicable to antigen detection, including those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days; Isolation observation personnel, including personnel in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area; Community residents with antigen self-test needs.
At the same time, the plan defines the main conditions to be met by the three groups for antigen detection and the access to detection reagents, and formulates the disposal management process after the detection is found to be positive, so as to promote the connection between antigen detection and nucleic acid detection.
It is also clear 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 News Agency reporter Chen Jimin photographed "SRC =" https://dfscdn.dfcfw.com./download/B9865740904370233345&direct=1 "Style =" border: PX solid 000000 "title =" on March 2, the automated production line in Guangzhou Wondfo Biotech Co.Ltd(300482) Guangzhou, Guangdong Province is producing covid-19 antigen detection reagent for Hong Kong. On the same day, 6 million copies of covid-19 antigen detection reagent produced by Guangzhou Wondfo Biotech Co.Ltd(300482) were hoisted from Humen Port Wharf and shipped to Hong Kong. China News Agency reporter Chen Jimin photographed "crawlerimgoriginalurl =" http://i2.chinanews.com.cn./simg/cmshd/202203/12/14df023bb8084da6be49e49ad392cc3d.jpg
Data figure: on March 2, Guangzhou, Guangdong Province, the automated production line in Guangzhou Wondfo Biotech Co.Ltd(300482) is producing covid-19 antigen detection reagent for Hong Kong. Photographed by China News Agency reporter Chen Jimin
what is antigen detection? What are the advantages
So, what is antigen detection? What is the difference between it and the previous large-scale nucleic acid detection? Zhang Wenhong, director of the infection department of Huashan Hospital Affiliated to Fudan University, explained in an interview with the media.
He said that the antigen is like the "clothes" worn outside the virus, and the nucleic acid is the gene inside the virus. The two tests are slightly different. The detection method of antigen is to test clothes from antibodies. After synthesizing the specificity, the virus can be displayed; Nucleic acid detection is more complex and needs to be completed by amplification. Because with the amplification link, the sensitivity of nucleic acid detection will be higher, but the corresponding time to obtain the results will be longer.
Zhang Wenhong said that in the first stage of China's anti epidemic, the rapid battle through nucleic acid detection has achieved "zero", but recently we have also found that after the Omicron mutant came out, the overall speed of virus transmission is accelerating, not only in Shanghai, including other parts of the country, there are more patients in different regions, but also the speed of virus transmission is very fast in a short time. At this time, it will be found that if the detection speed only depends on nucleic acid, it will be difficult.
Zhang Wenhong said that because nucleic acids need to borrow machines, and there is a very professional system for sampling requirements and machine amplification, antigen detection can be carried out at home, and the speed is very fast. It can also be detected in hospitals with poor conditions, and the cost is relatively low.
He also said that everything has its two sides. The sensitivity of antigen detection is slightly lower because it is not amplified, but once it is positive, it will have strong value. The Hong Kong anti epidemic has adopted antigen detection, and the institutions involved in the anti epidemic have also recognized this detection method. Through antigen detection, we can directly declare whether we are infected with covid-19, and then take a series of measures.
Rapid antigen detection kit (for drawing)
antigen detection will reach 100 billion in the Chinese market
Some analysts believe that the publication of the plan means that China's covid-19 virus detection market will transition from nucleic acid detection to the hierarchical diagnosis stage of "nucleic acid detection as the main and antigen detection as the supplement". Covid-19 antigen detection products are expected to usher in a market scale of more than 100 billion yuan.
Zhongtai Securities Co.Ltd(600918) research report points out that referring to the overseas distribution policy, the distribution frequency of overseas covid-19 antigen self-test kit varies significantly, ranging from 2 to 10 times per capita. At present, the ex factory unit price of China's covid-19 antigen self-test kit is about US $1-1.5. If China's antigen self-test kit is officially released, referring to overseas policies and assuming the minimum frequency twice a month, it is expected that the market scale of China's covid-19 antigen self-test kit is expected to reach 17.7-26.6 billion yuan per month.
Taking into account the purchase by residents and enterprises at their own expense, it is expected that the purchase demand of covid-19 antigen detection products is expected to further increase. According to this calculation, the annual market scale is expected to exceed 100 billion yuan.
China News financial reporter learned that at present, covid-19 antigen self-test kits of many in vitro diagnostic manufacturers in China have been registered and approved overseas.
For example, Andon Health Co.Ltd(002432) had already obtained the listing approval of the US market, and successively announced that it had signed large orders for covid-19 antigen self-test reagent with relevant US departments. The company's viral antigen can be released to the market by the China pharmaceutical regulatory center before the approval of the National Drug Administration on the 19th.
In the Chinese market, covid-19 antigen detection products of Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., Nanjing Vazyme Biotech Co.Ltd(688105) wholly owned subsidiary Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. and other enterprises have been approved to be listed in China, and some of them still have certain service conditions.
On the 12 day, Nanjing Vazyme Biotech Co.Ltd(688105) announced that the New Coronavirus antigen detection kit developed by its wholly owned subsidiary of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. received the medical device registration certificate issued by the State Administration of Drug Supervision recently.
It is said that the above New Coronavirus antigen detection kit can be used to detect New Coronavirus N antigen and S antigen in oral and throat swabs and nasopharyngeal swabs samples from New Coronavirus infected people. The above products are generally used in acute infection period, that is, sample detection within 7 days of symptoms of suspected people. It can be used as an auxiliary and supplement for nucleic acid detection, and further improve the ability of early detection with New Coronavirus detection strategy.
