Original title: Must-see big news! The first batch of new crown antigen self-test kits have been approved, and 3 listed companies may benefit… How to self-test?Detailed explanation of the National Health Commission
On March 12, the State Food and Drug Administration issued a notice approving the application changes of self-testing application of new crown antigen products of Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio. Five new crown antigen self-test products were officially launched. The day before, the National Health Commission had released news that in order to further optimize the new coronavirus detection strategy and serve the needs of epidemic prevention and control, after research, the State Council’s comprehensive team of the joint prevention and control mechanism for the new coronavirus pneumonia epidemic decided to increase the number of antigens on the basis of nucleic acid detection. detection as a supplement.
Five companies’ products have been approved and three are related to listed companies
According to the pending information on the medical device approval document (change) published on the website of the State Food and Drug Administration on March 12, Wanfu Bio, Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., a subsidiary of BGI, and Beijing Jinwofu Bioengineering Technology Co., Ltd. Co., Ltd., Nanjing Novizan Medical Technology Co., Ltd., and Beijing Huaketai Biotechnology Co., Ltd. developed 5 novel coronavirus antigen detection kits that have passed the registration information change of the Food and Drug Administration.
Among the companies approved for the new crown antigen self-test product this time, Wanfu Bio, Nanjing Novozymes’ parent company Novozymes and Shenzhen Huada Yinyuan’s parent company Huada Gene are all listed companies.
Market data shows that as of December 31, 2021, Wanfu Bio had 37,814 shareholders; as of November 15, 2021, Novozymes had 25,037 shareholders; as of September 30, 2021, Huada Gene has 72,371 shareholders.
Shares of a number of new crown testing companies have risen on Friday. Among them, because of the daily limit for two consecutive days, the company issued an announcement on abnormal stock price fluctuations on Friday, saying that the company’s board of directors had inquired about shareholders holding more than 5% of the company’s shares, all directors, supervisors and senior managers of the company. There is no information that needs to be corrected or supplemented; the company has not found any undisclosed material information recently reported by public media that may or have had a greater impact on the company’s stock trading price; the company’s current operating conditions and internal and external operating environments have not undergone major changes ; The company’s controlling shareholders and shareholders holding more than 5% of the shares do not have any major matters about the company that should be disclosed but not disclosed, or major matters in the planning stage; during the period of abnormal stock fluctuations, the company’s controlling shareholders, holding more than 5% of the shares The shareholders of the company, as well as the company’s directors, supervisors, and senior management personnel, do not buy or sell the company’s stock.
Novozymes, a company listed on the Science and Technology Innovation Board, also issued an announcement after its subsidiary’s new coronavirus antigen detection kit was approved, saying that the new coronavirus antigen detection kit can be used to detect oropharyngeal swabs and nasopharyngeal swabs for people suspected of new coronavirus infection. Novel coronavirus N and S antigens in subsamples. However, the company’s products are generally used in the acute infection period, that is, the detection of samples within 7 days of the onset of 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”.
The company emphasizes that the confirmation of new coronavirus infection should be combined with nucleic acid testing, imaging and other diagnostic information, as well as medical history and contact history to determine the infection status. The above-mentioned novel coronavirus antigen detection kits of the company cannot be used alone for the diagnosis of novel coronavirus infection, and should be used by professionally trained personnel in an environment that ensures biosafety and meets the conditions of use.
As for the impact of the approval of new products on the company’s performance, Novozymes emphasized that the actual sales of the products are affected by many factors such as changes in the new crown epidemic, prevention and control policies, and testing needs. The company cannot predict the future performance of the product’s approval. Investors are advised to pay attention to investment risks.
The National Health and Medical Commission announced to increase antigen testing as a supplement
The website of the National Health Commission announced on the 11th that in order to further optimize the new coronavirus detection strategy and serve the needs of epidemic prevention and control, after research, the comprehensive team of the State Council’s joint prevention and control mechanism for the new coronavirus pneumonia epidemic decided to add antigen testing on the basis of nucleic acid testing. As a supplement, and organized the formulation of the “New Coronavirus Antigen Detection Application Plan (Trial)” (hereinafter referred to as the “Plan”).
The “Plan” stipulates the applicable population of antigen testing: first, those who go to primary medical and health institutions for treatment, with symptoms such as respiratory tract and fever, and have symptoms within 5 days; Personnel in close contact, entry quarantine observation, closed and controlled areas, and control areas; the third is community residents who need antigen self-testing.
The “Plan” also clarifies the main conditions that the above-mentioned 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.
According to the “Plan”, community residents who have self-test needs can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
In order to facilitate the standardized testing in various places, the “Plan” also includes two annexes, namely the basic requirements and procedures for the new coronavirus antigen detection in primary medical and health institutions, and the basic requirements and procedures for the new coronavirus antigen self-testing.
The National Health and Medical Commission also emphasized that nucleic acid testing is still the basis for the diagnosis of new coronavirus infection, and antigen testing can be used as a supplementary method to screen specific groups of people, which is conducive to improving the ability of “early detection”. Primary medical and health institutions that have nucleic acid testing capabilities should prefer nucleic acid testing; those who do not have nucleic acid testing capabilities may conduct antigen testing, and provide training for medical staff and communication and guidance for patients. Isolation observers and community residents should carefully read the instructions and standardize their operations for antigen testing. Once the antigen test is positive, they should immediately report to the relevant departments; when necessary, nucleic acid testing should be carried out to confirm.
How to test yourself?
It is proposed in the trial plan that community residents who have self-test needs can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
There are three steps in antigen self-test.
First, prepare for the antigen self-test.
1. Wash your hands. Wash hands with running water or hand sanitizer.
2. Understand the testing process. Carefully read the instruction manual of the antigen self-test reagent and the precautions related to the antigen self-test.
3. Reagent preparation. Check whether the antigen self-test reagent is within the shelf life, and check whether the contents of the nasal swab, sampling tube, test card, etc. are missing or damaged. If the reagent expires or the contents of the reagent are missing or damaged, the detection reagent should be replaced in time.
4. Confirm the testing requirements for ambient temperature and humidity. The detection of colloidal gold test strips generally requires normal temperature conditions of 14°C-30°C to avoid abnormal test results caused by excessive cooling, overheating or excessive humidity. Unpack the antigen test card and place it in a flat, clean place.
Second, sample collection.
1. Those over 14 years old can perform nasal swab sampling by themselves. The self-tester first blows his nose with toilet paper. Carefully unpack the nasal swab to avoid touching the swab tip with your hands. Then tilt the head slightly, hold the swab in one hand and stick the tail of the swab into one nostril and enter it slowly along the bottom of the lower nasal passage to go back 1-1.5 cm, then stick to the nasal cavity and rotate for at least 4 circles (the residence time is not less than 15 seconds), and then Repeat the same for the other nasal cavity using the same swab.
2. Those who are 2-14 years old for self-examination should be sampled by other adults. When sampling, first blow the nose with toilet paper, and then tilt the head slightly. Sampling personnel carefully unpack the nasal swab, avoid touching the swab head with hands, gently support the head of the person being collected with one hand, hold the swab with the other hand and stick it into one nostril, and slowly penetrate backward along the bottom of the lower nasal passage. After 1 cm, stick to the nasal cavity and rotate at least 4 times (remaining time not less than 15 seconds), and then use the same swab to repeat the same operation for the other nasal cavity.
Third, antigen detection.
1. According to the instructions of the reagent, put the nasal swab after collecting the sample into the sampling tube immediately. The swab head should be rotated and mixed in the preservation solution for at least 30 seconds. 5 times to ensure that the sample is fully eluted in the sampling tube.
2. Squeeze the liquid of the swab head through the outer wall of the sampling tube by hand, and then discard the swab. After capping the sampling tube, drop the liquid vertically into the sample hole of the test card.
3. According to the reagent instructions, wait for a certain period of time to interpret the results. Positive results: red or purple bands are displayed at both “C” and “T”, and the color of the band at “T” can be dark or light, all of which are positive results. Negative Result: Red or purple band at “C”, no band at “T”. Invalid result: No red or purple band is displayed at “C”, regardless of whether the band is displayed at “T”. If the result is invalid, you need to take the test strip and test again.
How are the test results handled?
If the antigen test is positive, regardless of whether there are symptoms of respiratory tract, fever, etc., residents should immediately report to the community (village) where they live, and the community (village) will contact the emergency center to transfer the residents to a fever clinic in accordance with the guidelines for the transfer of personnel related to the new coronary pneumonia epidemic. medical institutions for nucleic acid testing. Sampling swabs, sampling tubes, test cards, etc. used by positive persons are put into sealed bags and transported to medical institutions for disposal as medical waste.
If the antigen test is negative, asymptomatic residents can be closely observed, and then undergo antigen or nucleic acid testing when necessary; symptomatic residents are advised to go to a medical institution with a fever clinic for nucleic acid testing as soon as possible; if it is inconvenient to seek medical treatment, they should stay at home Self-isolation, avoid going out, wear masks correctly, wash hands frequently and ventilate frequently, and perform antigen self-test once a day for 5 consecutive days.
Sun Chunlan: It takes the shortest time to achieve social zero in areas with severe epidemics
According to Xinhua News Agency, Beijing, March 12, the State Council’s joint prevention and control mechanism held a teleconference on the 12th. Member of the Political Bureau of the CPC Central Committee and Vice Premier of the State Council Sun Chunlan attended the meeting and delivered a speech. She emphasized that it is necessary to thoroughly implement the spirit of General Secretary Xi Jinping’s important instructions, implement the decisions and deployments of the CPC Central Committee and the State Council, adhere to the general strategy of “foreign import, domestic rebound” and the general policy of “dynamic clearing”, and take decisive measures. , to control local clustered epidemics as soon as possible, and consolidate the results of epidemic prevention and control.
State Councilor and Secretary-General of the State Council Xiao Jie presided over the meeting.
Sun Chunlan pointed out that the epidemic has occurred frequently in my country recently, and the prevention and control situation is complicated and severe. Areas with severe epidemics should carry out strict prevention and control work, expand the scope of nucleic acid screening, speed up flow investigation and transfer isolation, and strictly implement management measures for centralized isolation, home isolation, closed and controlled areas, and control areas to completely block community transmission. , to achieve social zero in the shortest time. The top priority of epidemic prevention and control is external defense imports, the focus is on ports, and the key is closed-loop protection. People, objects, and the environment are protected together. Staff in designated hospitals, quarantine hotels, airport terminals, and cross-border truck drivers cannot be. Contact with people outside the ring, and resolutely guard the defense line of external defense input. Schools and other places where people gather should consolidate the “quartet” responsibilities, strengthen daily health monitoring, increase the proportion of nucleic acid testing and sampling, and prevent clustered epidemics. According to the characteristics of Omicron’s transmission, the “antigen screening, nucleic acid diagnosis” monitoring mode should be promoted, and the public can purchase tests by themselves, which is conducive to early detection and improves the sensitivity of monitoring and early warning. All localities and departments should earnestly take responsibility, strengthen supervision and accountability, and do a good job of epidemic prevention and control as always, and take practical actions to welcome the victory of the 20th National Congress of the Communist Party of China.