New Coronavirus Antigen Detection Application Plan Trial Notice and Policy Interpretation

Notice on the trial implementation of the new coronavirus antigen detection application plan

In order to guide various localities in the scientific and rational application of new coronavirus antigen detection, standardize the management of treatment after a positive antigen test, and further improve the "early detection" capability, This plan was specially formulated.

1. Applicable groups for antigen testing

Persons who go to primary medical and health institutions with symptoms such as respiratory tract and fever and within 5 days of the onset of symptoms.

Persons under quarantine and observation include those in home quarantine and observation, those in close contact and sub-close contact, those in entry quarantine and observation, and those in sealed and controlled areas.

Community residents who need antigen self-testing.

2. Application of Antigen Testing in Primary Medical and Health Institutions

Primary medical and health institutions have nucleic acid testing capabilities when treating people with respiratory, fever and other symptoms within 5 days of symptom onset. Institutions that do not have nucleic acid testing capabilities should first conduct nucleic acid testing; those that do not have nucleic acid testing capabilities should conduct antigen testing.

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 when conducting antigen testing: 1. Sample collection and testing personnel must undergo biosafety training and technical operation training, and pass the assessment. 2. Equipped with appropriate instruments and equipment such as biological safety cabinets, and protect medical personnel during the testing process. 3. Testing operations should be carried out in a relatively independent and well-ventilated space; if primary medical and health institutions have laboratory conditions, testing operations are encouraged to be carried out in the laboratory. 4. Establish a reporting, transfer system and work flow for those who test positive for antigen tests.

Disposal of test results.

1. For those who test positive for antigens, primary medical and health institutions should immediately report to the disease control department in the jurisdiction, and the emergency center will transfer the antigen-positive people to fever clinics in accordance with the guidelines for the transfer of personnel related to the new coronavirus epidemic. Medical institutions conduct nucleic acid testing.

2. For those who have negative antigen tests, primary medical and health institutions should provide symptomatic treatment, instruct them to observe at home, conduct antigen tests once a day for 5 consecutive days starting from the day of treatment, avoid social activities, and wear masks correctly. Wash hands frequently and ventilate frequently. If the antigen result remains negative until the symptoms disappear, no other intervention measures may be taken. Once the antigen result is positive, the positive person must immediately report to the community where he/she lives. The community will contact the emergency center to transfer the person to a medical institution with a fever clinic for nucleic acid testing in accordance with the guidelines for the transfer of personnel related to the new coronavirus epidemic. Sampling of positive persons after use Swabs, sampling tubes, test cards, etc. are put into sealed bags and transported to medical institutions for disposal as medical waste.

Equipment of detection reagents. The provision of antigen detection reagents in grassroots medical and health institutions will be included in the centralized bidding and procurement. Provincial centralized procurement can continuously reduce the price of detection reagents and reduce the burden of testing costs.

3. Antigen testing application for quarantined personnel

Home quarantine observation, close contact and sub-close contact, entry quarantine observation, personnel in sealed and controlled areas and control areas shall be carried out by relevant management departments Good organization and management. During the isolation and observation period, nucleic acid testing will be carried out in accordance with the requirements of the current relevant prevention and control plans, and antigen self-testing will be conducted once a day for the first 5 days.

Main conditions to be met. Antigen testing for isolated observation personnel must meet the following conditions: 1. Establish an antigen self-testing management process, including receiving antigen testing reagents, checking personnel information, supervising the testing process, and reporting results, etc. 2. Isolation observation personnel must read the instructions carefully and carry out sampling, adding samples, result interpretation and other operations in a standardized manner in accordance with the prescribed requirements and procedures; qualified management departments must supervise and manage the testing process to ensure that the test results are authentic and credible. 3. Do a good job in waste disposal. After testing, the sampling swabs, sampling tubes, test cards, etc., regardless of whether the results are negative or positive, will be put into sealed bags and handled by management personnel in accordance with medical waste or procedures.

Disposal of test results. If the antigen test is positive, a nucleic acid test must be conducted immediately for confirmation.

Equipment of detection reagents. The management department that organizes isolation observation is responsible for the procurement, distribution, management and other related work of antigen detection reagents.

4. Application of Antigen Testing for Community Residents

If community residents need self-testing, they can purchase antigen testing reagents for self-testing through retail pharmacies, online sales platforms and other channels.

Things to note.

In order to ensure the quality of sampling and testing, residents need to read the instructions carefully, follow the prescribed requirements and procedures, and perform operations such as sampling, adding samples, and interpreting results in a standardized manner.

Disposal of test results.

1. If the antigen test is positive, regardless of whether there are respiratory, fever and other symptoms, residents should immediately report to their community, and the community will contact the emergency center to transport the residents to the hospital in accordance with the guidelines for the transfer of personnel related to the new coronavirus epidemic. Medical institutions that have set up fever clinics will conduct nucleic acid testing. Sampling swabs, sampling tubes, test cards, etc. used by positive persons are put into sealed bags and transferred to medical institutions for disposal as medical waste.

2. If the antigen test is negative, asymptomatic residents can be closely observed and undergo antigen testing or nucleic acid testing if necessary; residents with symptoms are recommended to go to a medical institution with a fever clinic as soon as possible for nucleic acid testing. Test; if it is inconvenient to see a doctor, you should self-isolate at home, avoid going out, and perform an antigen self-test every 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. During the nucleic acid test confirmation process, if the nucleic acid test is positive, regardless of whether the antigen test result is positive or negative, corresponding measures will be taken as if the patient is infected with the new coronavirus or a confirmed patient with new coronavirus pneumonia; if the nucleic acid test is negative but the antigen test is positive, it will be treated as if the nucleic acid test is negative but the antigen test is positive. People infected with the new coronavirus are subject to 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 testing, all localities must do a solid job in training medical staff in primary medical and health institutions so that they can fully understand the characteristics of antigen testing. and operational points to ensure that test results are accurate and reliable, and to educate patients and residents on antigen testing-related knowledge. When conducting antigen self-tests, the public must carefully follow the relevant basic requirements and procedures, and conduct nucleic acid testing for confirmation when necessary.

Policy Interpretation of the New Coronavirus Antigen Detection Application Plan

In order to further optimize the new coronavirus detection strategy and 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 "antigen screening" The monitoring model is "check-up, nucleic acid diagnosis", which adds antigen testing as a supplement to nucleic acid testing. Recently, the Mechanism Comprehensive Group formulated and issued the "New Coronavirus Antigen Detection Application Plan", requiring all localities to carefully organize and implement it.

The "Plan" stipulates the applicable groups for antigen testing: first, people who go to primary medical and health institutions with symptoms such as respiratory tract and fever and within 5 days of the onset of symptoms; second, people who are under quarantine and observation, including Home quarantine observation, close contacts and sub-close contacts, entry quarantine observation, people in sealed and controlled areas and control areas; the third is community residents who need antigen self-testing. At the same time, it clarified the main conditions that three categories of people need to meet for antigen testing and the channels for obtaining testing reagents. It also formulated a management process for disposal after a positive test is found to promote the connection between antigen testing and nucleic acid testing. In order to facilitate the standardized testing in various places, the "Plan" also includes two annexes, namely, the basic requirements and procedures for COVID-19 antigen testing in primary medical and health institutions, and the basic requirements and procedures for COVID-19 antigen self-testing.

It should be noted that nucleic acid testing is still the basis for confirming 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 "early detection" capabilities. If primary medical and health institutions have nucleic acid testing capabilities, nucleic acid testing should be the first choice; if they do not have nucleic acid testing capabilities, antigen testing can be performed, and medical staff training and patient communication guidance should be provided. Isolated observation personnel and community residents should carefully read the instructions and standardize the operation when conducting antigen testing. Once the antigen test is positive, they should immediately report to the relevant departments; if necessary, conduct nucleic acid testing for confirmation.