Antigen test for people:
1, to primary health care institutions, accompanied by respiratory, fever and other symptoms and symptoms within 5 days.
2. Persons under quarantine observation, including those under home quarantine observation, close and sub-confinement, inbound quarantine observation, and those in sealed and controlled areas.
3. Community residents with antigenic self-testing needs.
Application of antigen testing for people under quarantine observation:
People in home quarantine observation, close and sub-close contact, inbound quarantine observation, sealed and controlled areas and control areas are well organized and managed by the relevant management departments (e.g., communities, villages and towns, quarantine sites, etc.). Nucleic acid testing is carried out during the isolation observation period in accordance with the current requirements of the relevant prevention and control programs, and antigen self-testing is conducted once a day for the first 5 days.
1. Main conditions to be met. Isolated observation personnel to carry out antigen testing need to meet the following conditions at the same time: 1. Establishment of antigen self-testing management process, including antigen test reagents, personnel information verification, testing process supervision, results reporting, etc. 2. Isolated observation personnel need to carefully read the instructions, in accordance with the requirements and procedures specified, standardized sampling, sample addition, results interpretation and other operations; conditional management departments to carry out testing process Supervision and management to ensure that the test results are true and credible. 3. Testing after the use of sampling swabs, sampling tubes, test cards, etc., regardless of the results of negative or positive, are packed into a sealed bag by the management personnel with reference to medical waste or according to the procedures for disposal.
2, the disposal of test results. Positive antigen test shall be immediately confirmed by nucleic acid test.
3, test reagents. The management department that organizes the isolation observation (e.g., community, village, isolation site, etc.) is responsible for the procurement, issuance and management of antigen detection reagents and other related work.
Legal basis
"The State Food and Drug Administration Comprehensive Department on the new coronavirus antigen detection reagents quality and safety supervision of the work of the notice"
One of the strengthening of the registration-related management work
Provincial drug supervision and management departments should strengthen the research and development of the registration process guidance, and do a good job of declaring the registration of the registered products registration The quality management system verification work, to ensure that the enterprise R & D process standardization, registration declaration information is true, accurate, complete and traceable.
Three, strengthen the supervision and inspection of the operation
According to the State Council's response to the new coronavirus pneumonia epidemic joint prevention and control mechanism issued by the integrated group of the new coronavirus antigen detection application program (for trial implementation) "clear" community residents have the need for self-testing, can be through the retail drugstores, network sales platforms and other channels, to buy their own antigen test reagents "for self-testing" requirements. During the epidemic prevention and control period, retail pharmacies and medical device enterprises that have obtained drug licenses or medical device licenses and have the appropriate storage conditions can sell new coronavirus antigen test reagents. Local drug supervision and management departments at all levels should further do a good job in the supervision and inspection of the new coronavirus antigen test reagents business enterprises, supervision and guidance of enterprises from the legally qualified medical device registrants, production and operation of enterprises to purchase the new coronavirus antigen test reagents, do a good job of purchase inspection and sales and other records, equipped with appropriate facilities and equipment, to ensure that the product transportation, storage conditions in line with the labeling and instructions of the labeling requirements. Focus on whether the new coronavirus antigen test reagents operated by the enterprise are approved by the registration and have qualified documents, whether the product manual contains instructions for consumers to use on their own. To engage in network sales of medical devices business enterprises, but also to urge its main page of the website prominently display the medical device license, in the product page to display the medical device registration certificate and other information.
Provincial drug supervision and management departments should continue to strengthen the new coronavirus testing reagents network trading information monitoring and disposal efforts, monitoring the illegal clues found to be timely investigation and handling organization. Strengthen the supervision and inspection of the jurisdiction of the medical device network trading services third-party platform, supervision and guidance of its strict implementation of the network of medical device operators of real-name registration, qualification audit, management of business practices, and other obligations, illegal sales of medical devices found to be illegal behavior, should be stopped in a timely manner and reported to the drug supervision and management departments.
Four, crack down on violations
Drug supervision and management departments at all levels should attach great importance to network monitoring, complaints and reports, public opinion monitoring, supervision and inspection, supervision and sampling and other channels reflected in the case of clues to the unauthorized production and operation, production and operation of unregistered new coronavirus antigen test reagents and other violations, shall be investigated and dealt with strictly according to law. Suspected of committing a crime, to be promptly transferred to the public security organs.