In addition to nucleic acid detection, covid-19 self-test policy has also been officially implemented.
In March 11th, the national health and Health Committee announced that after the study, the State Council responded to the comprehensive prevention and control mechanism of New Coronavirus pneumonia, and decided to add antigen detection on the basis of nucleic acid detection, and formulated the "COVID-19 virus antigen detection application plan (Trial Implementation)".
National Health Commission: residents can buy reagents to test covid-19 virus antigen
According to the official website of the National Health Commission, 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 on the basis of nucleic acid detection. Recently, the mechanism integration group formulated and issued the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the scheme), which requires all localities to seriously organize and implement.
The scheme specifies the applicable population for antigen testing:
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 above 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.
In order to facilitate standardized testing in various regions, the plan also includes two annexes, namely, the basic requirements and procedures for covid-19 virus antigen testing in grass-roots medical and health institutions, and the basic requirements and procedures for covid-19 virus antigen self-testing.
It should be noted 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. When conducting antigen testing, isolation observers and community residents should carefully read the instructions and standardize the operation. Once the antigen test is positive, they should immediately report to the relevant departments; If necessary, conduct nucleic acid test for confirmation.
Screenshot source: Official Website of National Health Commission
Affected by this, in the afternoon of March 11, the A-share covid-19 detection sector collectively pulled up in a 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%.
community residents covid-19 virus antigen self-test how to operate
community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels
(I) matters needing attention. In order to ensure the quality of sampling and testing, residents need to carefully read the instructions and carry out sampling, sample addition, result interpretation and other operations in a standardized manner in accordance with the specified requirements and processes.
Basic requirements and process of covid-19 virus antigen self-test
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(II) disposal of test results.
\u3000\u3000 1. If the antigen test is positive, regardless of whether there are 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 hot diagnosis for nucleic acid test according to 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
\u3000\u30002. 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; If it is inconvenient to see a doctor, you should isolate yourself at home, avoid going out for activities, and conduct antigen self-test once a day for 5 consecutive days.
confirmation of nucleic acid detection
Nucleic acid detection is the basis for the diagnosis of covid-19 virus infection. In the process of nucleic acid test confirmation, if the nucleic acid test is positive, no matter whether the antigen test result is positive or negative, corresponding measures shall be taken according to covid-19 virus infected patients or covid-19 pneumonia diagnosed patients; If the nucleic acid test is negative but the antigen test is positive, it shall be regarded as covid-19 virus infected, take centralized isolation and other measures, closely observe and continuously carry out nucleic acid test.
several companies responded to covid-19 testing business
In fact, many overseas enterprises have registered vid-19 antigen self-test kits in China.
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. 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) covid-19 antigen detection reagent products passed the emergency approval of China nmpa in November 2020 and became 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, covid-19 antigen self-test product developed by Zhejiang Orient Gene Biotech Co.Ltd(688298) and Siemens Medical in cooperation was approved by the US 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.
Tianfeng Securities Co.Ltd(601162) believes that at present, the closed loop of "vaccine + detection + therapeutic drugs" is gradually formed, covid-19 epidemic situation will not disappear in a short time, and covid-19 antigen detection may become an important supplementary means for epidemic prevention and control in China. According to the latest statement, "improve the normalization prevention and control and emergency response mechanism for sudden outbreaks, highlight the focus of epidemic prevention and control in port areas, and hold the bottom line of no large-scale rebound of the epidemic", China's antigen detection may become an important supplementary means of epidemic prevention and control. There are three main reasons:
1. Chinese antigen detection products are mature and the sensitivity can reach 90% European antigen testing has been implemented for more than a year and has been verified for epidemic prevention and control.
2. The production capacity of the products is sufficient. In 2021, China exported covid-19 test kits worth 66.893 billion yuan overseas, and the production expansion cycle of the enterprise is relatively short.
\u3000\u30003. Specific application scenarios require rapid response of antigen detection, for example, ports, airports, shipping and other places are places with high risk of covid-19 virus infection. The cost of nucleic acid detection is high and the detection speed is slow every day. Antigen detection or more convenient control is provided.
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.
Deppon securities commented that China's covid-19 antigen detection scheme (Trial) was officially released and is optimistic about relevant industrial opportunities. Antigen detection has been officially recognized in developed countries such as Europe and the United States, and its sensitivity and sensitivity have been verified. In the recent epidemic in Hong Kong, antigen detection has played an important role in the rapid screening of covid-19 patients, further highlighting the significance of antigen detection.
