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National Health Commission: Residents can purchase reagents to test their own new coronavirus antigens

author:Lingtai released

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 to nucleic acid detection. Community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.

Application protocol for antigen detection of new coronavirus

(Trial)

In order to guide the scientific and rational application of new coronavirus antigen testing in various localities, standardize the disposal management after positive antigen testing, and further improve the "early detection" ability, this plan is specially formulated.

1. Antigen testing is applicable to the population

(1) Persons who go to primary medical and health institutions for medical treatment, accompanied by respiratory tract, fever and other symptoms, and who have symptoms within 5 days. 

(2) Personnel in isolation and observation, including personnel in home isolation observation, close and sub-close contact, entry isolation and observation, sealing and control areas, and control areas. 

(3) Residents of communities with antigen self-testing needs. 

2. Application of antigen detection in primary medical and health institutions 

When primary level medical and health establishments receive patients with respiratory tract, fever, and other symptoms and symptoms within 5 days, institutions with nucleic acid testing capabilities shall prefer nucleic acid testing; 

(1) The main conditions to be met. In order to ensure quality and safety and avoid cross-infection between doctors and patients, primary medical and health institutions must meet the following conditions at the same time to carry out antigen testing: 1. Sample collection and testing personnel should undergo biosecurity training and technical operation training, and pass the assessment. 2. Have suitable instruments and equipment such as biological safety cabinets, and do a good job of medical personnel protection during the testing process. 3. Testing operations should be carried out in a relatively independent and well-ventilated space; where primary medical and health institutions have laboratory conditions, they are encouraged to carry out testing operations in laboratories. 4. Establish reporting, transfer systems and work processes for personnel who test positive for antigens. 

(2) Disposal of test results.

1. For persons with positive antigen tests, primary medical and health institutions shall immediately report to the disease control department of the jurisdiction, and the emergency center will transfer the antigen positive personnel to a medical institution that has set up a fever clinic for nucleic acid testing in accordance with the guidelines for the transfer of personnel related to the new crown pneumonia epidemic.

2. For persons with negative antigen tests, primary medical and health institutions shall give symptomatic treatment, instruct them to observe at home, and conduct antigen tests once a day for 5 consecutive days from the day of treatment, avoid social activities, wear masks correctly, wash their hands and ventilate frequently. If the antigen result remains negative until symptoms disappear, no other interventions may be taken. Once the antigen result is positive, the positive person needs to immediately report to the community (village) where he or she is located, and the community (village) contacts the emergency center to transfer it to a medical institution that has set up a fever clinic for nucleic acid testing in accordance with the guidelines for the transfer of personnel related to the new crown pneumonia epidemic; the sampling swabs, sampling tubes, test cards, etc. after the positive person uses it are loaded into a sealed bag and transferred to the medical institution for medical waste disposal. 

(3) The allocation of testing reagents. Grass-roots medical and health institutions equipped with antigen detection reagents are included in centralized bidding and procurement, and can continuously reduce the price of testing reagents and reduce the burden of testing costs through centralized procurement at the provincial level. 

Third, the application of antigen detection in isolated observers

Personnel in home isolation observation, close and sub-close contact, entry isolation observation, sealing and control areas, and control areas are to be organized and managed by the relevant management departments (such as communities, villages, towns, isolation points, etc.). During the isolation and observation period, nucleic acid testing is carried out in accordance with the requirements of the current relevant prevention and control programs, and antigen self-testing is carried out once a day for the first 5 days. 

(1) The main conditions to be met. Isolation and observation personnel for antigen detection must meet the following conditions at the same time: 1. Establish an antigen self-testing management process, including antigen detection reagent collection, personnel information verification, detection process supervision, result reporting, etc. 2. Isolation observers need to carefully read the instructions, in accordance with the requirements and procedures of the regulations, standardize the sampling, sampling, result interpretation and other operations; the conditional management department should supervise and manage the testing process to ensure that the test results are true and credible. 3. Do a good job of waste disposal. After the test, the sampling swab, sampling tube, test card, etc., regardless of whether the result is negative or positive, are loaded into a sealed bag and treated by the management personnel with reference to medical waste or according to the procedure. 

(2) Disposal of test results. If the antigen test is positive, a nucleic acid test must be carried out immediately to confirm it. 

(3) The allocation of testing reagents. The management department that organizes isolation observation (such as communities, villages, towns, isolation points, etc.) is responsible for the procurement, distribution, management and other related work of antigen detection reagents. 

Fourth, the application of antigen detection for community residents 

Community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels. 

(1) Matters that need attention. In order to ensure the quality of sampling and testing, residents need to carefully read the instructions and carry out sampling, sampling, and result interpretation in a standardized manner in accordance with the prescribed requirements and procedures. 

1. If the antigen test is positive, regardless of whether there are respiratory tract, fever and other symptoms, residents should immediately report to the community (village or town), and the community (village) shall contact the emergency center to transfer the residents to the medical institution that has set up a fever clinic 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.

2. Antigen-negative, asymptomatic residents can be closely observed, and then carry out antigen detection or nucleic acid testing when necessary; symptomatic residents are recommended to go to the medical institution that sets up fever clinics as soon as possible for nucleic acid testing; if it is inconvenient to seek medical treatment, they should self-isolate at home, avoid outdoor activities, and conduct antigen self-testing once a day for 5 consecutive days.

5. Confirmation of nucleic acid testing 

Nucleic acid testing is 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 new crown pneumonia confirmed 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.

6. Personnel training and publicity and education

In the process of applying antigen detection, all localities should do a solid job in the training of medical personnel in grass-roots medical and health institutions, so that they can fully grasp the characteristics and operational points of antigen detection to ensure that the test results are accurate and reliable, and do a good job of publicity and education on antigen detection knowledge to patients and residents. When conducting antigen self-testing, the public should conscientiously follow the relevant basic requirements and procedures, and when necessary, conduct nucleic acid testing to confirm.