As the epidemic continues to spread everywhere, the demand for new crown virus testing is also increasing, and antigen self-testing has become an important supplement to virus screening. On March 11, the official website of the National Health and Health Commission released a message saying that 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 to nucleic acid testing. Community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels. Antigen testing is fast, efficient and inexpensive, but it should be emphasized that nucleic acid testing is still the basis for confirming the diagnosis of new coronavirus infection.
Three groups of people can be self-tested
According to the "Application Plan for Antigen Detection of the New Coronavirus" (hereinafter referred to as the "Plan") issued by the National Health and Health Commission, the applicable groups of antigen testing include three categories: one is to go to primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and symptoms within 5 days; second, isolation and observation personnel, including home isolation observation, close and sub-close connection, entry isolation observation, sealing and control areas and control areas; third, community residents with antigen self-testing needs.
At the same time, the "Plan" clarifies the main conditions that the three groups of people need to meet for antigen testing, the channels for obtaining testing reagents, and formulates the disposal management process after the test is found positive, so as to promote the connection between antigen detection and nucleic acid detection. In order to facilitate the standardized testing in various places, the Plan also includes two annexes, namely, the basic requirements and procedures for the detection of new coronavirus antigens in primary medical and health institutions, and the basic requirements and procedures for self-testing of new coronavirus antigens.
The National Health Commission reminds that if the antigen test is positive, regardless of whether there are respiratory tract, fever and other symptoms, residents should immediately report to their communities (villages and towns), and the community (villages and towns) will contact the emergency center to transfer residents to medical institutions that set up fever clinics for nucleic acid testing in accordance with the guidelines for the transfer of personnel related to the new crown pneumonia epidemic. After the positive person uses the sampling swab, sampling tube, test card, etc., into a sealed bag and transported to the medical institution for medical waste disposal.
Residents with negative antigen tests and asymptomatic can be closely observed and then undergo antigen testing or nucleic acid testing when necessary; residents with symptoms are recommended to go to a medical institution that has set up a fever clinic as soon as possible for nucleic acid testing; if it is inconvenient to seek medical treatment, they should self-isolate at home, avoid going out, and conduct antigen self-testing once a day for 5 consecutive days.
Costs about 20% of nucleic acid testing
The current new crown detection methods include nucleic acid, antigen and antibody detection, in the international community, generally use nucleic acid detection and antigen detection at the same time, the country is currently mainly based on nucleic acid detection, antigen detection has not been widely used.
During the two sessions of the National People's Congress this year, Huang Ailong, member of the National Committee of the Chinese People's Political Consultative Conference and president of Chongqing Medical University, suggested that a normalized epidemic prevention and control model combining "large-scale rapid detection of antigens based on home self-testing + targeted small-scale precision nucleic acid detection" should be built as soon as possible.
Huang Ailong's research found that at present, nucleic acid testing can only be carried out in professional institutions such as laboratories or hospitals, requiring professional operation, usually taking several hours or so to obtain results, nucleic acid testing is expensive, time-consuming, and slow to produce results. When a confirmed patient appears in a place and needs to carry out nucleic acid detection and screening, large-scale queuing testing is organized, and there is a risk of cross-infection of personnel gathering.
Huang Ailong introduced, "Compared with nucleic acid detection and antibody detection, antigen rapid detection has many advantages such as simple operation, fast and efficient, wide application, low cost, safety and reliability, which can greatly reduce the burden on medical staff and medical and health institutions." In addition, the rapid detection of antigens does not take more than 30 minutes to obtain results, the cost of reagents is about 20% of nucleic acid detection, if the organization is strong, in a short period of time, you can complete the screening of ultra-large-scale people in various conferences, sports events and other large-scale activities.
Nucleic acid testing remains the basis for confirming the diagnosis
On the day of the release of the antigen testing news, the information on the official website of the State Food and Drug Administration also showed the dynamics of the market: nanjing Nuoweizan Medical Technology Co., Ltd.'s new crown virus antigen detection kit (colloidal gold method) was approved on March 11.
Zhongtai Securities said that the new crown antigen home self-test is suitable for large-scale general screening self-examination and is an effective supplement to nucleic acid detection. At present, hundreds of in vitro diagnostic manufacturers in China have registered and approved the self-test kit of the new crown antigen in china. If the domestic new crown antigen self-test products are released for registration and approval, the head brand with complete and rich clinical data and relatively large overseas sales may gain an advantage.
However, although antigen testing can be used for screening specific populations, it is beneficial to improve "early detection" capacity. However, the Plan makes it clear that nucleic acid testing is still the basis for confirming the diagnosis of new coronavirus infection. In the process of nucleic acid test confirmation, if the nucleic acid test is positive, regardless of whether the antigen test result is positive or negative, corresponding measures are taken according to the new crown virus infection or the confirmed new crown pneumonia patient; if the nucleic acid test is negative but the antigen test is positive, it is regarded as the new crown virus infected person to take measures such as centralized isolation, close observation, and continuous nucleic acid testing.
Therefore, the National Health Commission stressed that if the grass-roots medical and health institutions have nucleic acid testing capabilities, nucleic acid testing should be preferred; those who do not have nucleic acid testing capabilities can conduct antigen testing, and do a good job in medical staff training and patient communication guidance. Sample collection and testing personnel of basic level medical and health establishments shall go through biosecurity training and technical operation training, and pass the assessment; they must also have appropriate instruments and equipment such as biological safety cabinets, and do a good job of protection for medical personnel during the testing process.
In addition, isolated observers and community residents should carefully read the instructions and standardize operations for antigen testing, and 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.
Beijing Business Daily reporter Yang Yuehan Lu Yinling
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