In view of the transmission characteristics of Omicron, China began to promote the monitoring mode of "antigen screening and nucleic acid diagnosis" to achieve early detection and improve the sensitivity of monitoring and early warning.
On March 11, the joint prevention and control mechanism of the State Council issued the notice on printing and distributing the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the scheme), which proposed to add antigen detection as a supplement on the basis of nucleic acid detection.
An epidemiologist reminded that covid-19 antigen detection still faces challenges in the actual fight against the epidemic, and a series of problems need to be further refined, such as whether the antigen detection products purchased by residents need to be filed, whether someone is responsible for tracking the self-test results after filing, and whether community control is carried out immediately after the self-test positive report of residents, If the positive results are not reported, whether there are relevant supervision measures, etc. All these problems are related to whether antigen detection can be truly accepted by the public, and then related to the market capacity.
However, the capital market has given a warm response. On the day of the release of the plan, the shares of listed companies related to antigen testing rose sharply.
During the period of overseas covid-19 epidemic, covid-19 antigen has become an important means of residents' self-detection, and the detection reagent is in short supply. At the moment of Omicron epidemic, can covid-19 antigen detection products create a new "myth" of anti epidemic products?
how to detect antigen early
The Omicron epidemic in China has followed the characteristics of the international epidemic - rapid transmission. Even under the control policy of dynamic clearing, it still quickly spread to more than 20 provinces in the country within two months. How to find and dispose of the epidemic earlier and faster is the top priority of covid-19 epidemic prevention and control.
On the day of the joint defense and joint control mechanism issued by the State Council, in March 11th, the State Administration of Drug Administration approved the registration of New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd.
On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology.
For the approval of covid-19 antigen detection products, the relevant departments (device audit center of the State Food and Drug Administration) believe that covid-19 virus antigen detection reagents are only multiple means for prevention and control. It has enriched the types of covid-19 virus detection reagents, expanded the supply of covid-19 virus detection reagents, and further served the needs of epidemic prevention and control. However, it can not be used alone for the diagnosis of New Coronavirus infection. It should be combined with nucleic acid detection, imaging and other diagnostic information and history, contact history to determine the infection status. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people.
can the detection of covid-19 antigen make the epidemic detection earlier
In Annex 2 of the protocol on the basic requirements and process of covid-19 virus antigen self-test, "self-test instructions" clearly states that "antigen test is generally used in the acute infection period, that is, the sample test within 7 days of symptoms of suspected people."
This is actually the basic condition for covid-19 antigen detection to work.
\u3000\u3000 "Antigen detection reagents can only be used for patients who are already in the acute stage of disease and can only be detected when the viral load is relatively high. At present, there are many asymptomatic patients in China, and antigen detection may not be detected basically. In fact, at this time, we need nucleic acid detection methods with early and minimal viral load, so as to find asymptomatic infections as soon as possible and control the further spread of the epidemic and the progress of the disease Further development. " A person in charge of producing covid-19 virus nucleic acid detection reagent said. This is also the reason why nucleic acid is the gold standard for covid-19 virus detection.
On March 12, in Yufeng Garden community, Liulin street, Hexi District, Tianjin, staff prompted residents to go downstairs for nucleic acid detection with speakers. Xinhua news agency.
At present, when Omicron is the main epidemic strain, the number of asymptomatic infections has exceeded the confirmed cases for several consecutive days. According to the epidemic information released by the National Health Commission, it can be seen that asymptomatic cases account for 40-70%, and some provinces and cities even account for more than 90%.
However, the above person in charge believes that if Omicron affects a large area, antigen detection can assist in diagnosis for areas lacking nucleic acid detection ability.
"Increasing covid-19 virus antigen detection can be used by residents, individual clinics and grass-roots medical institutions that do not have the ability to detect covid-19 virus nucleic acid, or play the role of early detection of the epidemic." An epidemiologist said.
For example, if there are a large number of people in the sealed control area and the control area, the nucleic acid detection and waiting time for the results are long, and the antigen detection is convenient and takes a short time, it can play a better supplementary role at this time. Relatively, the positive cases can be found as soon as possible, and the "surrounding circle" of subsequent nucleic acid detection can be more accurate, which will relatively speed up the time of discovery.
The principle of antigen detection is the same in individual clinics and grass-roots medical institutions that do not have the ability to detect covid-19 virus nucleic acid. This principle is applicable to the third group of people.
antigen test result disposal needs to be improved
However, for antigen detection, how residents' antigen self-test connects with the epidemic prevention system still needs further attention.
According to the plan, antigen detection is applicable to three groups of people. One is those who go to grass-roots medical and health institutions and have symptoms such as respiratory tract and fever within 5 days. The second is to 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.
Among them, one of the main conditions to be met in the application of antigen detection in grass-roots medical and health institutions is to establish the reporting, transportation system and workflow of antigen positive personnel.
The isolation observer shall carry out antigen detection, and the relevant management departments (such as communities, villages and towns, isolation points, etc.) shall do a good job in organization and management. One of the main conditions to be met is to establish an antigen self-test management process, including antigen detection reagent collection, personnel information verification, detection process supervision, result reporting, etc.
However, for the third category, that is, community residents who need antigen self-test, "does the information of antigen products purchased by residents need to be filed? Who is responsible for tracking the self-test results of residents after filing? How to report the positive self-test results of residents? Whether community control should be carried out immediately after reporting? These questions need to be further refined.
”An epidemiologist said.
According to the provisions of the plan, if the community residents are positive for antigen test, regardless of whether they have respiratory tract, fever and other symptoms, the residents shall immediately report to the community (Village) where they are located. The community (Village) shall contact the emergency center to transfer the residents to the medical institution with fever clinic for nucleic acid test in accordance with the covid-19 guidelines for the transfer of personnel related to the pneumonia epidemic. The sampling swabs, sampling tubes and test cards used by positive personnel are put into sealed bags and transferred to medical institutions for medical waste disposal.
"At present, the tentative plan is to take the community channel. For those who do not report the positive results, there are no relevant supervision measures yet." The above epidemiological experts said.
However, the problem is that there are no detailed operating rules on how to upload the negative information, how to display it after uploading, and whether it can be recognized as some kind of evidence. These will become the key factors for whether antigen detection reagents will be accepted and used by residents.
another myth of capital market
Five covid-19 antigen self-test reagents that have been approved for listing in China are gradually being introduced to the market.
"We are already accepting orders." The first financial reporter learned from insiders of Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) . SH) that the current distribution price of covid-19 antigen self-test reagent is 14.5 yuan / copy.
On the morning of March 13, meituan takeout app showed that existing pharmacies were selling covid-19 antigen self-test products. It is shown that the price of covid-19 antigen hanging out of the flagship store of a pharmacy is 30.8 yuan / copy, and the reagent kit manufacturer displayed in the pharmacy is Beijing jinwofu.
The customer service staff of the store said that after being photographed, it is expected to ship on March 20.
China is one of the major producers of antigen detection products, but it is mainly used for export in the early stage.
Miss Zhang, who works in Hong Kong, China, told the first financial reporter that the price of covid-19 antigen reagent sold in Hong Kong fluctuated greatly. At the beginning, the price was about 40 or 50 Hong Kong dollars, but now it has been reduced to 20 Hong Kong dollars. "If there are large quantities, you can find manufacturers to order, and the price is about HK $10."
In addition, according to the recent statistics of Southwest Securities Co.Ltd(600369) Research Report, except for a few countries (such as Iceland), the mainstream countries in Europe allow the sales of covid-19 antigen household self-test products. The European supply market is relatively sufficient, and the price is significantly lower than that in the initial stage of listing. At present, the terminal price is about 2-3 euros.
Chinese enterprises that have obtained the covid-19 antigen reagent registration certificate for covid-19 antigen reagents in some regions or countries outside the country, including Chinese enterprises that have already obtained the covid-19 antigen reagent Registration Certificate in some regions or countries, include Chinese enterprises that include Guangzhou Wondfo Biotech Co.Ltd(300482) \ \enterprise.
Taking Guangzhou Wondfo Biotech Co.Ltd(300482) as an example, as early as the first half of 2021, its covid-19 antigen self-test reagent (colloidal gold method) successively passed the certification of Germany, Spain, Italy, Portugal, Luxembourg, Austria and other countries, and obtained the EU CE certification in early June of that year. The 2021 semi annual report shows that due to the early release of covid-19 self-test product screening in Germany, the market expansion is the most obvious, and its covid-19 sales revenue accounts for the largest proportion in Germany.
According to the analysis of industry experts, at present, the production capacity of covid-19 antigen reagent in China exceeds 20 million people per day.
In addition to the 19 enterprises that have applied for cod-5 to be listed in China, other enterprises have also been approved.
Sansure Biotech Inc(688289) ( Sansure Biotech Inc(688289) . SH) relevant personnel replied to the first financial reporter that the company has plans to apply for listing in China, but the specific progress has to be announced later.
With the approval of China to market covid-19 antigen reagent, how much market space will this bring to relevant enterprises?
Huaan Securities Co.Ltd(600909) in the latest research report, it is estimated that from a rational perspective, combined with three types of application scenarios, the market scale of diagnosis and treatment and detection needs of grass-roots medical and health institutions is about 5.5 billion yuan, the detection needs of isolated observers is about 2.5 billion yuan, and the self inspection needs of community residents is about 24.9 billion yuan, with an overall total of more than 30 billion yuan. From a long-term perspective, assuming that the society under the normalization of covid-19 is open, it can be divided into static self-test and dynamic large-scale test according to the application scenarios of covid-19 antigen detection. In a comprehensive view, the market scale of antigen detection in a long-term perspective is 270 billion yuan. However, as mentioned above, the market size assumptions made by securities analysts, especially the self inspection needs of community residents, did not take into account the actual situation under the current epidemic prevention requirements. The disposal of self inspection results, including the connection of information and the recognition of test results, are the preconditions for making assumptions, but these preconditions are not perfect at present.
The research report also said that the specific industrial chain can be divided into upstream raw materials, midstream product manufacturing and production and downstream terminal sales. The gross profit distribution of the industry is calculated according to the relevant gross profit margin level of the industry. After the calculation, the gross profit of the upstream, midstream and downstream accounts for 14%, 24% and 60% respectively based on the terminal sales price. In the future, the whole covid-19 antigen upstream, middle and downstream industrial chain has great prospects.
Is covid-19 antigen product really expected to continue the capital myth brought by anti epidemic products such as masks, nucleic acid detection, respirators and vaccines?
An industry analyst believes that even from the perspective of price, it is a little difficult for antigen products to create a myth. "In terms of price, the price of anti epidemic products has been reduced to a reasonable range, the nucleic acid detection has been reduced from 260 yuan to more than 30 yuan, the mask has been reduced from 20 yuan to less than 1 yuan, and the vaccine has been reduced from 200 yuan to less than 20 yuan. It can be seen that covid-19 antigen products cannot be produced at a high price, because it is not the gold standard product for covid-19 diagnosis, but only an auxiliary product, so the rigid demand is not high Feet. "
"It is certain that when residents have symptoms and are in the acute attack of the disease, it is more suitable to go to the doctor and carry out nucleic acid testing. After all, they are already in the attack of the disease." The person in charge said. He also believes that in unspecified areas or asymptomatic cases, antigen detection is difficult to detect early, so the real demand of the market can not be predicted.
