On March 11, the National Health Commission announced that 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).
The plan specifies the applicable population for antigen testing, and defines the main conditions to be met for antigen testing for the three groups of people and the access to testing reagents. The plan also specifically proposes that community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
In the afternoon of March 11, the A-share covid-19 detection sector pulled up in a collective straight line. As of the closing closing closing, the end of the closing closing of the closing of the closing of the closing of the closing of the end of the end of the closing, 30048ofthe\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\individualstocks such as , Lepu Medical Technology (Beijing) Co.Ltd(300003) , Shenzhen New Industries Biomedical Engineering Co.Ltd(300832) , Maccura Biotechnology Co.Ltd(300463) and Maccura Biotechnology Co.Ltd(300463) rose more than 10%.
Although vid-19 has the advantages of being used as a self-test reagent for virus detection and prevention in China, it can only be used as a supplementary antigen in the market. The reporter of securities times · e company learned that at present, many companies in China have the production capacity of antigen detection products and have obtained the listing qualification of many overseas countries.
\u3000\u Qingdao Tgood Electric Co.Ltd(300001)
China releases covid-19 antigen detection
At present, nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection, and antigen detection, as a supplementary means, can be used for screening of specific populations, which is conducive to improving the ability of "early detection".
● according to the plan, covid-19 virus antigen detection reagent can be used by personnel with respiratory or fever symptoms within 5 days, isolation observers and community residents with antigen self-detection needs. When receiving patients with respiratory tract and fever symptoms within 5 days, grass-roots medical and health institutions should first carry out nucleic acid detection. If they do not have the ability of nucleic acid detection, they can carry out antigen detection.
The plan proposes that community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels. If the antigen test is positive, no matter whether there are respiratory tract, fever and other symptoms, residents shall immediately report to the community (village and town) where they are located. If the antigen test is negative, asymptomatic residents can observe closely and carry out antigen test or nucleic acid test when necessary; Residents with symptoms are advised to go to the medical institution with fever clinic as soon as possible for nucleic acid testing.
The issuance of the notice means that China's covid-19 detection market will be dominated by nucleic acid detection and transition to the hierarchical diagnosis stage of "nucleic acid detection as the main and antigen detection as the supplement". This will also open up a huge market space for antigen detection on the basis of the existing nucleic acid detection market.
So, what is the difference between nucleic acid detection and antigen detection?
● data show that compared with nucleic acid detection, antigen detection has the advantages of convenience, quickness and low cost. Even the results can be obtained in more than ten minutes after detection, and ordinary people can also easily realize home detection. Europe, America, Australia, Japan and other regions have taken the lead in launching the application of antigen detection.
A chief doctor of a third class hospital told the reporter of securities times · e company that China has been slow to start the application of antigen detection because nucleic acid detection is the gold standard for detecting covid-19 positivity. The sensitivity of antigen detection is significantly lower than that of nucleic acid detection. Usually, only strong positive samples can be detected, with a certain probability of false negative, and there may be missed detection. Therefore, antigen detection can be used as a simple covid-19 virus screening method, but after self-test, it also needs to go to the hospital for further nucleic acid detection before final confirmation.
In the latest notice issued by the National Health Commission, the user population and subsequent treatment methods are also defined: antigen detection is generally used in the acute infection period, that is, the sample detection within 7 days of the symptoms of the suspected population. Further nucleic acid detection should be carried out for the antigen positive and negative results of the suspected population. The positive results can be used for the early diversion and rapid management of the suspected population, but can not be used as the basis for the diagnosis of covid-19 virus infection.
Zhongtai Securities Co.Ltd(600918) analysts pointed out 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. Covid-19 antigen self-test kit can effectively reduce the risk of exposure and reduce the resource occupation of hospitals and third-party laboratories. It is usually used for a wide range of general screening and self-examination of residents.
The analyst also said that due to the lack of methodology, the sensitivity and accuracy of covid-19 antigen self-test are lower than those of nucleic acid detection, and the test results need to be reported by individuals. Therefore, this product is an effective supplement to nucleic acid detection. The rules for the use of antigen self-test in the United States, the European Union, Australia and other places clearly point out that nucleic acid detection can be supplemented but cannot be replaced.
\u3000\u Beijing Ultrapower Software Co.Ltd(300002)
involves 100 billion market
It is understood that the clinical requirements of the EU and the United States for covid-19 antigen self-test kit refer to the interim guidance documents of the who, including core indicators such as sensitivity, specificity, positive coincidence rate and negative coincidence rate, but there are no strict regulations on the number of clinical participants. The registration and approval of covid-19 antigen self-test products in China may be stricter.
So how long will it take for antigen kits to be used on a large scale? Pharmaceutical industry analyst Wang Jun (pseudonym) told the reporter of securities times · e company that enterprises will be able to go public soon after they get the product approval and listing documents. However, the approval time depends on the category of covid-19 antigen self-test kit in the policy. If it is included in Innovation Medical Management Co.Ltd(002173) device special review procedure or medical device priority approval process, the approval time is expected to take 3-12 months. If the policy includes it in the application for class III Registration Certificate of conventional in vitro diagnostic reagents, the approval process may take 1-3 years.
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. Facing such a big market cake, how will enterprises take a share? Compared with nucleic acid detection, what is the cost of antigen detection reagents and what are the thresholds for enterprises to obtain approval qualification?
The relevant person in charge of Guangdong Weishi Biotechnology Co., Ltd. (hereinafter referred to as "Weishi biotechnology") told reporters that compared with the nucleic acid detection kit, the antigen detection kit will involve more raw materials, such as NC membrane, colloidal gold binding pad, sample pad, water absorption pad, support pad (PVC sector), etc., and the unit cost should be equivalent to that of the nucleic acid detection kit, But people use it more quickly and conveniently. The entry threshold of enterprises is not high, but it is difficult to do well. For example, enterprises need to have colloidal gold preparation technology and labeling technology, immunological technology such as antigen and antibody, and process optimization technology.
\u3000\u Lepu Medical Technology (Beijing) Co.Ltd(300003)
many companies have obtained overseas qualifications
In fact, at present, covid-19 antigen self-test kits of many in vitro diagnostic manufacturers in China have been registered and approved overseas.
Andon Health Co.Ltd(002432) , whose share price had risen more than 10 times in two months, was approved by the U.S. market and successively announced that it had signed large orders for covid-19 antigen self-test reagent with relevant U.S. departments.
The relevant person in charge of Weishi biology told reporters that its covid-19 antigen detection kit is mainly sold in Europe. Recently, orders from Hong Kong, Vietnam, Malaysia and other countries or regions have been in large quantities. Because there is no Chinese registration certificate, there is no sales in the Chinese market except in the international navigation crew channel. In the future, with the introduction and promotion of government policies, it is believed that the market can be opened in China soon.
On March 11, Guangzhou Wondfo Biotech Co.Ltd(300482) ranked first in the related concept sector with an increase of 20%. The reporter of securities times · e company learned that Guangzhou Wondfo Biotech Co.Ltd(300482) of covid-19 antigen detection reagent products passed the emergency approval of China nmpa in November 2020, becoming the first batch of enterprises in China to obtain the registration certificate of covid-19 antigen detection reagent. At present, the product has been sold in more than 100 countries in Europe, Asia, Latin America, the Middle East and other regions.
In the semi annual report of 2021, Guangzhou Wondfo Biotech Co.Ltd(300482) said that since the fourth quarter of 2020, China's covid-19 reagent export has changed to focus on antigen detection products, and the international market environment is facing great changes. Especially in the European market, the family self-test diagnosis represented by antigen detection has refreshed the traditional diagnosis concept, improved the efficiency of hierarchical diagnosis and treatment, and the demand for products has increased rapidly Guangzhou Wondfo Biotech Co.Ltd(300482) the covid-19 antigen self-test reagent (colloidal gold method) obtained the EU CE certification in early June.
Recently, Guangzhou Wondfo Biotech Co.Ltd(300482) also participated in supporting Hong Kong's anti epidemic work. According to Kang Keren, Guangzhou Wondfo Biotech Co.Ltd(300482) senior vice president, covid-19 antigen rapid detection is easy to operate, has no special requirements for operators and does not depend on equipment. It can realize on-site detection and produce results in 15-20 minutes.
On March 11, Zhejiang Orient Gene Biotech Co.Ltd(688298) announced that up to now, the company's covid-19 antigen detection reagent has not obtained the Chinese certification certificate, and the company will fulfill the obligation of announcement after obtaining the certificate.
Although Zhejiang Orient Gene Biotech Co.Ltd(688298) said that it had not obtained the Chinese certification certificate, Zhejiang Orient Gene Biotech Co.Ltd(688298) as one of the earliest enterprises in China to develop covid-19 antigen rapid detection technology, it is the first enterprise in China to obtain the CE certification for covid-19 antigen rapid diagnosis. At the end of last year, Zhejiang Orient Gene Biotech Co.Ltd(688298) and Siemens Medical jointly developed covid-19 antigen self-test product, which won the EUA of FDA.
In addition, Maccura Biotechnology Co.Ltd(300463) , Bgi Genomics Co.Ltd(300676) , Dian Diagnostics Group Co.Ltd(300244) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) and other companies have obtained the listing qualification of overseas covid-19 antigen detection reagent.
On March 10, Maccura Biotechnology Co.Ltd(300463) announced that the company's covid-19 virus antigen self-test product has recently been registered as a medical product by the Australian drug administration.
In addition, Bgi Genomics Co.Ltd(300676) also announced in early February that the covid-19 antigen self-test product of the wholly-owned subsidiary of European medicine has obtained the EU CE certificate. In fact, as early as February 2021, covid-19 virus antigen detection kit (colloidal gold method) developed by Huada Yinyuan, a subsidiary of Bgi Genomics Co.Ltd(300676) holding company, has obtained EU CE access qualification.
Lets Holdings Group Co.Ltd(002398) once said on the interactive platform that the average daily production capacity of the participating company Aode biological covid-19 virus antigen detection reagent is about 3 million people. At present, the products are mainly sold to the German market. Many retailers and hospitals in Germany have purchased Aode biological kits in large quantities. At present, they have obtained orders for covid-19 virus antigen detection reagents for about 100 million people.
Dian Diagnostics Group Co.Ltd(300244) said that at present, the production capacity of covid-19 antigen detection products of the company is Shanghai Pudong Development Bank Co.Ltd(600000) people per day, which will be increased to 1 million people per day in the future through plant expansion and process optimization. Covid-19 virus antigen detection kit is mainly sold in Germany, Austria and other European countries.
Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) said on the interactive 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 registered countries. 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.
