(Fighting against New Coronary Pneumonia) China Approves 5 New Coronary Antigen Self-Test Products for Listing Experts Analyze the Application Value
China News Agency, Beijing, March 12th: China approves 5 new crown antigen self-test products for listing, experts analyze the application value
China News Agency reporter Li Chun
China's State Drug Administration issued a notice on the 12th, approving the launch of 5 new crown antigen self-test products.
Wang Daming, a researcher at the Suzhou Institute of Biomedical Engineering Technology, Chinese Academy of Sciences, pointed out in an exclusive interview with a reporter from China News Agency that antigen detection, as a supplementary method, has its application value and can learn from each other's strengths.
According to the website of the State Food and Drug Administration, Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio have been approved for application changes in the application of new coronavirus antigen detection kits in the past two days.
Since then, 5 new crown antigen self-test products have been officially launched.
On the 11th, the Comprehensive Team of the Joint Prevention and Control Mechanism of the State Council announced the "New Coronavirus Antigen Detection Application Plan (Trial)", and decided to promote the monitoring mode of "antigen screening and nucleic acid diagnosis", adding antigen detection on the basis of nucleic acid detection as a supplement. It also stipulates 3 types of applicable populations for antigen testing, namely:
People who go to primary medical and health institutions for treatment, have respiratory symptoms, fever and other symptoms and have symptoms within 5 days;
Isolation observation personnel, including home isolation observation, close contact and sub-close contact, entry isolation observation, closed control area and personnel in control area;
Community residents who need antigen self-testing.
What is the difference between antigen testing and nucleic acid testing?
Wang Daming said that the inside of the virus is genetic nucleic acid, and the outside is a layer of protein.
Nucleic acid detection is for the genes of the virus, and antigen detection is for the outer proteins.
Zhang Wenhong, head of the Shanghai New Coronary Pneumonia Clinical Treatment Expert Team and director of the Department of Infectious Diseases of Huashan Hospital Affiliated to Fudan University, also said in an interview with the media that antigen testing starts from antibodies to test "clothes". After comprehensive specificity, the virus can be displayed. ; Nucleic acid detection is more complicated and needs to be done by amplification, and its sensitivity will be higher, but the time required to obtain results is correspondingly longer.
In addition, the "Plan" also regulates the antigen self-test process and management.
Personnel in home isolation observation, close contact and sub-close contact, entry isolation observation, closed control area and control area shall carry out nucleic acid testing according to the requirements of the current relevant prevention and control plan during the isolation observation period, and conduct antigen self-test once a day for the first 5 days .
Community residents who have self-test needs can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
At the same time, Chinese officials have also issued the "Basic Requirements and Procedures for Antigen Self-Testing of Novel Coronavirus", which regulates the basic requirements and operating procedures for antigen self-testing.
When quarantined observers and community residents conduct antigen tests, they should carefully read the instructions and standardize operations to ensure accurate results.
Wang Daming believes that whether the self-test can be standardized and accurate depends on two aspects: one is the use design of the product, and the other is the difficulty of user acceptance.
The operation of the test kit itself is not complicated, which is the basis for the public to use it for themselves.
The instructions for use are generally based on illustrations, which are convenient for users to understand and operate accordingly.
It should be pointed out that antigen detection can be used as a supplementary method to screen specific groups of people, which is conducive to improving the ability of "early detection", but nucleic acid detection is still the basis for the diagnosis of new coronavirus infection.
Once the antigen test is positive, it should be reported to the relevant departments immediately; if necessary, nucleic acid test should be carried out to confirm.
The "Plan" issued this time also formulates the disposal management process after a positive test is found, and promotes the connection between antigen detection and nucleic acid detection.
For example, for people with positive antigen test, primary medical and health institutions should immediately report to the disease control department under their jurisdiction, and the emergency center will transfer the antigen-positive people to medical institutions with fever clinics for nucleic acid testing in accordance with the guidelines for the transfer of people related to the new coronary pneumonia epidemic.
"In fact, the relevant regulations are very clear." Wang Daming believes that the application of antigen testing and the management of "antigen-positive personnel" in the future need to be further integrated with the current prevention and control measures.
The expert pointed out that as one of the means of infectious disease prevention and control, antigen detection has been maturely applied in the prevention and control of other infectious diseases such as influenza.
As an auxiliary means, the detection of novel coronavirus antigen has its application value.
Considering the transmission characteristics of Omicron, it is a good thing to have one more prevention and control method.
Antigen detection is currently used as a primary screening measure for new coronavirus infection, and it can be used in conjunction with nucleic acid detection as the basis for diagnosis.
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