Recently, nucleic acid detection has become a hot spot of public concern. The relevant person in charge of the National Health Commission interpreted some issues of concern.
1. Why should multiple rounds of nucleic acid testing be carried out in the area where the epidemic occurs
At present, China’s epidemic prevention and control has entered a new stage of responding to the epidemic of the mutant strain of Omicron virus. Omicron mutant has the characteristics of faster transmission, shorter incubation period and stronger concealment. We must make it fast and cut off the virus transmission chain in time and effectively in order to achieve the maximum prevention and control effect with the minimum cost.
In case of aggregated epidemic, especially when the source of risk is unknown, the nucleic acid detection of the population in the designated area shall be completed within the specified time. Determine whether to conduct another round of nucleic acid screening according to the number of people and their risk distribution after the completion of the epidemic prevention and control. Only by “doing everything that should be done” as soon as possible, and “doing everything that should be done” for infected persons and close contacts, can we find the source of infection in time, cut off the route of transmission, and control the epidemic situation as soon as possible, can we reduce the rounds of nucleic acid testing; If we can’t do “all the tests that should be done” and “all the tests that should be done”, we will have to find out the infected person through more rounds of nucleic acid testing.
In the third edition of the guidelines for the implementation of regional nucleic acid testing organizations issued by us, guiding suggestions are given on the strategies of nucleic acid screening. All localities should study and refine them in combination with the actual situation, and do a good job in the organization and implementation.
2. Why should we carry out normalized nucleic acid testing in areas where there is no epidemic
The characteristics of Omicron variant make some early infected people difficult to be found. When the aggregated epidemic of Omicron occurred in many places in the early stage was found, it had been hidden and spread in the community for a period of time, which brought difficulties to the prevention and control work.
Among the various measures for epidemic prevention and control, nucleic acid detection is a key and effective means to quickly find the source of infection, lock the control target, and then take isolation and other measures to cut off the route of transmission. It has played an important role as a “sharp weapon” in the successful disposal of aggregated epidemics. In particular, the role of nucleic acid detection has become more prominent in the effective response to the epidemic situation of Omicron mutant in Jilin, Shanghai and Beijing since this year. Therefore, we must unswervingly implement the expanded prevention strategy centered on nucleic acid detection in order to better and more effectively respond to the epidemic.
Carrying out normalized nucleic acid detection in areas where there is no epidemic but high import risk is conducive to improving the sensitivity of epidemic monitoring and early warning, organizing a dense epidemic monitoring network, discovering potential risks earlier and better implementing the “four early” requirements; At the same time, it is conducive to providing more convenient and fast nucleic acid detection services for people who “should be tested and willing to be tested”. Therefore, all localities can carry out normalized nucleic acid detection in combination with the needs of local epidemic prevention and control.
3. What is the significance of establishing a “15 minute nucleic acid sampling circle”? Is it too expensive to deploy so many detection points
During the normalization of epidemic prevention and control, nucleic acid detection shall be carried out in accordance with the requirements of “all inspections should be carried out” for key populations and “all inspections willing” for other populations. In particular, a 15 minute walk nucleic acid “sampling circle” shall be established in provincial capital cities and cities with a population of tens of millions. The purpose is to facilitate people to take nucleic acid sampling nearby, so as to “detect early” and improve the sensitivity of epidemic monitoring and early warning.
At present, many cities and regions in China have successively explored the implementation of normalized nucleic acid detection, such as Shenzhen, Hangzhou, Dalian, Hefei, and many cities in Jiangxi Province and Hubei Province. According to the local reality, these cities reasonably arranged nucleic acid sampling points and organized citizens to conduct nucleic acid detection once in 48 hours and 7 days. On the whole, the operation was stable and achieved good results. In particular, through the joint procurement of nucleic acid testing reagents and other consumables in many places, some places have further reduced the testing cost, reduced the testing price, and promoted the orderly development of normalized testing. It is also understood that the relevant departments of the State Council are stepping up research to further guide all localities to reduce the cost and price of nucleic acid testing.
4. Is normalized nucleic acid detection mandatory
Normalized nucleic acid detection is determined according to the needs of local epidemic prevention and control. It is not required that all cities establish a 15 minute nucleic acid “sampling circle”, which is mainly concentrated in provincial capital cities and cities with a population of 10 million; It is not required that all people should be tested once every 48 hours. The specific testing frequency should be determined by the local government according to the occurrence and development of the epidemic and the needs of prevention and control.
5. How to avoid the risk of transmission caused by crowd aggregation when organizing large-scale nucleic acid testing
In order to guide local organizations to do a good job in large-scale nucleic acid testing and avoid crowd gathering, we have successively issued three versions of the guidelines for the implementation of nucleic acid testing organizations. There are four main points to note:
First, do a good job in work plan and organization management. Clarify the organizational structure and straighten out the whole chain workflow. The background of the actual population of each street, community and community within the jurisdiction shall be clear, and the current situation of nucleic acid sampling and detection ability shall be accurately mastered. Once launched, it is necessary to strengthen the coordination and overall planning of multiple departments, establish a flat working mechanism, work intensively when necessary, and do a good job in the organization and connection of the whole process of procurement, delivery, inspection and reporting.
Second, optimize the layout of sampling points. Based on the population, geographical transportation and distribution of nucleic acid testing institutions, the setting of sampling points is determined by referring to the standard of setting one sampling point for 20 Jinzai Food Group Co.Ltd(003000) people and one sampling station for Tian Jin Bohai Chemical Co.Ltd(600800) people. In principle, sampling points are set in the unit of community, and outdoor sampling points are given priority in this season; You can also choose well ventilated venues such as gymnasium, exhibition hall and school playground.
Third, strengthen the organization and management of sampling site. Set up clear guidance signs, plan the access routes, ensure the one-way flow of personnel, and clarify the sampling process and precautions. By making an appointment, notifying and sampling in advance at different time intervals, it can reduce the gathering of personnel in a short time and shorten the queuing time. The site shall be equipped with staff and volunteers to strengthen the maintenance of order, guide the people to do a good job in personal protection, maintain a safe distance and avoid cross infection. For the elderly, pregnant women, disabled and other groups, green channels should be set up for independent sampling to enhance humanized care.
Fourth, the public should actively cooperate. The public participating in nucleic acid testing should implement measures such as wearing masks and keeping a safe distance, and consciously obey the organization and management of the staff. During the sampling process, do not touch any object such as the sampling table, and leave as soon as possible after the sampling, so as to reduce the on-site stay and conversation.
6. How to ensure the accuracy of nucleic acid test results
In order to ensure the accuracy and reliability of nucleic acid test results, we mainly take the following measures:
First, strict testing qualification access. Strengthen the management of gene amplification testing laboratories, supervise the access of each laboratory carrying out nucleic acid testing, strengthen the qualification assessment of technicians, and constantly improve the access registration to ensure that the institutions and personnel entering meet the qualification requirements.
At present, there are about 13000 laboratories with covid-19 virus nucleic acid testing qualification and 153000 technicians with nucleic acid testing qualification.
Second, strict inspection quality control. While carrying out the indoor quality control of the laboratory in a normal way, we organize the national temporary inspection center to conduct the indoor quality evaluation of the laboratory every month. At present, more than 38000 laboratories have been evaluated, and the qualified rate is 99.4%. At the same time, in the large-scale nucleic acid screening, quality supervisors are assigned to each laboratory undertaking the testing task to supervise and guide its testing work in the whole process and ensure the testing quality.
Third, continuously optimize technical specifications. Two versions of covid-19 virus nucleic acid detection technical operation procedures have been formulated successively, and specific provisions have been made for the whole process of technicians, single sample collection, mixed sample collection, sample management, laboratory detection and result report. We innovated and carried out the detection technology of 5-in-1, 10-in-1 and 20-in-1 mixed collection, and successively updated the three versions of the organization and Implementation Guide for population nucleic acid screening.
Fourth, focus on strengthening the supervision of third-party testing institutions. Formulate and implement the Interim Measures for the management of medical laboratory and the measures for the management of large-scale covid-19 virus nucleic acid testing laboratory (for Trial Implementation), and regularly publish the list of qualified institutions; For laboratories with false negatives, false positives and even false test reports, strengthen supervision, deal with them according to law and regulations, and will not tolerate them.
In the next step, the National Health Commission will continue to strengthen the quality supervision of nucleic acid testing, make comprehensive use of various methods such as “flight inspection”, regular sampling inspection and publishing the list of qualified laboratories, so as to continuously improve the quality of nucleic acid testing and provide strong support for epidemic prevention and control.
