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The new crown self-test program is out! Is there a substitute for nucleic acid test results? Read it all!

In addition to queuing for nucleic acid testing, the new crown self-test program is also officially released.

On March 11, the website of the National Health commission issued an announcement that the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in Response to the Novel Coronavirus Pneumonia Epidemic issued the "Application Plan for The Detection of New Coronavirus Antigens (Trial)". The "Plan" pointed out that in order to further optimize the detection strategy of the new crown virus, 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 increase antigen detection as a supplement on the basis of nucleic acid detection to further improve the "early detection" capability.

1. Who is suitable for antigen testing?

The "Plan" stipulates that there are three categories of people who are suitable for antigen testing:

First, those who go to primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and have symptoms within 5 days;

The second is isolation and observation personnel, including personnel in home isolation observation, close contact and sub-close contact, entry isolation observation, sealing and control area and control area;

Third, residents of communities with antigen self-testing needs.

At the same time, the main conditions to be met for antigen detection in the three groups of people and the channels for obtaining detection reagents are clarified, and the disposal management process after the test is found positive is formulated to promote the convergence of antigen detection and nucleic acid detection.

2. Can antigen test results replace nucleic acid test results?

The answer is no. The notice made it clear that after research, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in response to the novel coronavirus pneumonia epidemic decided to add antigen detection as a supplement to nucleic acid testing. Nucleic acid testing remains the basis for confirming COVID-19 infection.

The "Basic Requirements and Procedures for Self-Testing of New Coronavirus Antigens" in the pilot plan also emphasizes that antigen testing is generally used for sample testing during the acute infection period, that is, within 7 days of the onset of symptoms in suspected people. Both positive and negative antigenic results in suspected populations should be further nucleic acid testing, and positive results can be used for early triage and rapid management of suspected populations, but cannot be used as a basis for confirming the diagnosis of new coronavirus infection.

3. What is the difference between nucleic acid testing and antigen detection?

Compared with nucleic acid detection, antigen detection has two advantages: convenient and fast.

Zhang Wenhong, director of the Department of Infectious Diseases at Huashan Hospital affiliated to Fudan University, said in an interview with STV on March 11, "Antigens are like the 'clothes' that our virus wears on the outside, and nucleic acid is the gene inside the virus, and the two tests are slightly different." Today, not only in Shanghai but also in other parts of the country, we have seen infected people in different areas, and in a very short period of time, the virus has spread very fast, so if our detection speed is still completely dependent on nucleic acids as it was at the beginning, we will have certain difficulties in prevention and control. Nucleic acid testing requires certain equipment and conditions, if the nucleic acid sampling in this place is not convenient, then antigen detection is fast and low cost. ”

Why did you use nucleic acid testing instead of antigen testing? Zhang Wenhong explained that this is because the antigen test is less sensitive than nucleic acid detection, but once it is tested positive, it has great value. In the future, if we have to face larger-scale detection, then we can achieve early detection and early isolation in a faster time.

4. Has the self-test kit been approved? Where can I buy?

Judging from the results and announcements of the database of the regulatory authorities, there is currently no new crown antigen detection kit for self-testing in China that has been approved.

The new crown self-test program is out! Is there a substitute for nucleic acid test results? Read it all!

However, from the data query on the official website of the State Drug Administration, it was found that there are currently three new crown antigen testing products approved in China, but they are not used for self-testing. The three models are from Guangzhou Wanfu Biotechnology Co., Ltd., Beijing Jinwolf Biotechnology Co., Ltd. and Shenzhen Huada Inyuan Pharmaceutical Technology Co., Ltd. Product details also indicate that these products should be used by professionally trained personnel in an environment that ensures biosecurity and meets the conditions of use, rather than for self-testing.

According to the "Application Plan for Antigen Detection of the New Coronavirus (Trial)", if community residents have self-testing needs, they can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.

Regarding the price of antigen testing, Huang Ailong, member of the National Committee of the Chinese People's Political Consultative Conference and president of Chongqing Medical University, analyzed in an interview with Zhongxin Jingwei on March 11 that the factory price of the reasonable range is about 5 yuan for 1 person, 8-10 yuan for 2 people, and the terminal price is not more than 20 yuan / person, which is far lower than the current price of products sold in Hong Kong. (Lu Yang)

The new crown self-test program is out! Is there a substitute for nucleic acid test results? Read it all!

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