China News Service, March 12 (Reporter Zhang Ni) On the evening of the 11th, with the announcement of the "New Coronavirus Antigen Detection Application Program (Trial)", "residents can purchase reagents to self-test new coronavirus antigens" has attracted great attention.
Some analysts believe that this means that nucleic acid testing will no longer be the dominant player in the domestic new coronavirus testing market in the future.
Why is antigen testing being implemented in China?
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 the 11th, the official website of the National Health and Medical Commission announced that in order to further optimize the detection strategy of the new coronavirus, 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". On the basis of detection, antigen detection is added as a supplement.
The "New Coronavirus Antigen Detection Application Plan (Trial)" formulated and issued by the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council stipulates 3 categories of people for which antigen detection is applicable, including those who go to primary medical and health institutions for treatment, have symptoms such as respiratory tract, fever, etc. Persons with symptoms within 5 days; quarantine observation personnel, including home quarantine observation, close contact and sub-close contact, entry quarantine observation, personnel in closed control areas and control areas; community residents who need antigen self-testing.
At the same time, the "Plan" clarifies the main conditions that three groups of people need to meet for antigen testing and the channels for obtaining testing reagents, and formulates the disposal management process after positive testing is found, so as to promote the connection between antigen testing and nucleic acid testing.
It is also clear that community residents who need self-testing can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.
Data map: On March 2, Guangzhou City, Guangdong Province, the automated production line in Wanfu Bio was producing new crown antigen detection reagents for Hong Kong.
Photo by China News Agency reporter Chen Jimin
What is an antigen test? What are the advantages?
So, what exactly is an antigen test?
How is it different from the previous large-scale nucleic acid testing?
Zhang Wenhong, director of the Department of Infectious Diseases at Huashan Hospital Affiliated to Fudan University, explained in an interview with the media.
He said that antigens are like the "clothes" worn on the outside of the virus, and nucleic acids are the genes inside the virus.
These two tests are slightly different. The antigen detection method starts from antibodies to test clothes. After the specificity is integrated, the virus can be displayed; while the nucleic acid detection is more complicated and needs to be completed by amplification, because with In the stage of amplification, the sensitivity of nucleic acid detection will be higher, but it will take longer to obtain the corresponding results.
Zhang Wenhong said that in the first stage of China's anti-epidemic, the rapid battle through nucleic acid detection achieved "zero", but recently everyone has also discovered that after the Omicron variant came out, the overall virus spread was accelerating, not only In Shanghai, including other parts of the country, there are more patients in different regions, and the virus spreads rapidly in a short period of time.
At this time, it will be found that if the detection speed only relies on nucleic acids, it will be difficult.
Zhang Wenhong said that because nucleic acids need to borrow machines, and there are very professional systems for sampling requirements and machine amplification, antigen testing can be performed at home, and the speed is very fast, and it can also be detected in hospitals with relatively poor conditions. , the cost is lower.
He also said that everything has its two sides. Antigen testing is slightly less sensitive because there is no amplification, but once it is positive, it will have strong value.
Antigen testing was adopted in Hong Kong's fight against the epidemic this time, and the institutions involved in the anti-epidemic also recognized this testing method. Through antigen testing, it is possible to directly declare whether or not to be infected with the new crown, and then take a series of measures.
Rapid antigen test kit (for photo)
Antigen detection in the domestic market scale will reach hundreds of billions?
Some analysts believe that the announcement of the "Plan" means that the domestic new coronavirus testing market will be dominated by nucleic acid testing, and transition to a stage of hierarchical diagnosis where "nucleic acid testing is the mainstay, and antigen testing is supplementary".
The new crown antigen detection products are expected to usher in a market size of more than 100 billion yuan.
The Zhongtai Securities Research Report pointed out that with reference to overseas distribution policies, the distribution frequency of overseas new crown antigen self-test kits varies significantly, ranging from 2-10 times per capita.
At present, the factory price of the domestic new crown antigen self-test kit is about 1-1.5 US dollars. If the domestic antigen self-test kit is officially released, with reference to overseas policies, the minimum frequency is assumed to be twice a month. It is estimated that the domestic new crown antigen self-test kit market is a single month The scale is expected to reach 17.7-26.6 billion yuan.
Taking into account the purchases of residents and enterprises at their own expense, it is expected that the purchase demand for new crown antigen detection products is expected to further increase.
According to this calculation, the annual market size is expected to exceed 100 billion yuan.
A reporter from China-News Finance and Economics learned that at present, many domestic in vitro diagnostic manufacturers have registered and approved the new crown antigen self-test kits overseas.
For example, Jiu'an Medical has previously obtained approval for listing in the US market, and has successively announced that it has signed large orders for new crown antigen self-test reagents with relevant US departments.
In addition, the company disclosed to the media a few days ago that its new coronavirus antigen detection product will be approved by the Drug Evaluation Center of the State Food and Drug Administration before it can be launched in China.
In the domestic market, the novel coronavirus antigen detection products of Wanfu Bio, Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., a subsidiary of BGI, and Nanjing Novizan Medical Technology Co., Ltd. Approved in the domestic market, some of which still have certain conditions of use.
On the 12th, Novizan issued an announcement stating that the novel coronavirus antigen detection kit independently developed and produced by its wholly-owned subsidiary Nanjing Novizan Medical Technology Co., Ltd. has recently received the "Medical Device Registration" issued by the State Drug Administration. certificate".
It is said that the above-mentioned novel coronavirus antigen detection kit can be used to detect the novel coronavirus N antigen and S antigen in oropharyngeal swabs and nasopharyngeal swab samples of people suspected of novel coronavirus infection.
The above products are generally used in the acute infection period, that is, the sample detection within 7 days of the symptoms of suspected people. It can be used as an aid and supplement to nucleic acid detection, in line with the national new coronavirus detection strategy, to further improve the ability of "early detection".
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