The first batch of NEW CORV antigen testing products for self-testing are approved!
On March 12, CCTV News reported that the State Food and Drug Administration issued a notice approving the application change of the self-test application of new crown antigen products of Nanjing Nuoweizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biologics, and Beijing Huaketai Biologics. Since then, five new crown antigen self-test products have been officially launched.
On the same day, the latest information to be collected released by the government affairs portal of the State Food and Drug Administration showed that the medical device approval documents (changes) obtained by the four new crown antigen detection kit products were to be collected, and the approval time was all on March 12, involving 4 companies, including Nanjing Nuoweizan Medical Technology Co., Ltd., a wholly-owned subsidiary of Nanjing Nuoweizan Biotechnology Co., Ltd. (Nuoweizan, 688105), Guangzhou Wanfu Biotechnology Co., Ltd. (Wanfu Biotechnology, 300482), Shenzhen BGI Inyuan Pharmaceutical Technology Co., Ltd. and Beijing Jinwolf Biotechnology Co., Ltd., a subsidiary of BGI Gene (300676).
Together with Beijing Huaketai, which was approved to change the previous day, the number of manufacturers approved to change has increased to 5.
A day earlier on March 11, the state food and drug administration government portal released the information to be collected, Beijing Huaketai Biotechnology Co., Ltd. new crown antigen testing products of the medical device approval documents (changes) to be collected, the approval date is March 11.
At present, a total of 5 new crown antigen testing products of 5 domestic enterprises have been approved, and it is the products of the above 5 changes in information. Previously, these products were only approved for professional use, not self-testing. The change to be collected information announced this time, the State Food and Drug Administration did not disclose the details of the product change, and some industry views believe that the information of this change may be allowed to be used for resident self-testing.
On March 12, the surging news reporter contacted the service hotline of Nanjing Nuoweizan, and a staff member said on the phone that the current change information on the official website of the Food and Drug Administration on the new crown antigen detection product was indeed changed from the professional version to the self-test version, and whether the self-test version began to be produced, the above staff said that it was not clear.
Also on March 11, the National Health Commission issued the "Application Plan for Antigen Detection of the New Coronavirus (Trial)", which clearly adds antigen detection as a supplement on the basis of nucleic acid testing, which mentions that community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.
Just one day later, five new crown antigen self-test products were officially launched.
Expert explanation
What is the difference between antigen testing and nucleic acid testing? How accurate is antigen detection and can it replace nucleic acid testing? Which scenarios are suitable for antigen detection? The surging reporter interviewed Professor Hu Bijie, a member of the national expert group on medical treatment of novel coronavirus pneumonia and director of the Department of Infectious Diseases of Zhongshan Hospital affiliated to Fudan University.
Nucleic acid testing is the "gold standard", and antigen detection is more convenient
Hu Bijie said that in general, nucleic acid testing is still the "gold standard" for new crown virus infection, which is more accurate; and antigen detection is a valuable supplement and more convenient.
Nucleic acid detection applies molecular biology principles, through reverse transcription, amplification, and quantitative detection of the nucleic acid sequence of pathogens, the sensitivity and specificity of virus detection are higher, and the accuracy is also higher. Antigen detection uses the principle of immunology to complete viral detection quickly in non-laboratory settings, which is an effective supplement to but not a substitute for nucleic acid detection.
"For example, if the positive rate of nucleic acid testing is 100%, then the detection rate of antigen testing is about 70%." Hu Bijie said.
However, nucleic acid testing is also more expensive than antigen testing. It is necessary to use professional instruments, places, and technicians, and the testing time is relatively long, at least one or two hours, usually 4-5 hours. Antigen detection can be self-tested anytime, anywhere, and the results are quick.
"The biggest advantage of antigen testing is that it is simple to operate and less costly." Hu Bijie said that antigen testing also usually uses nasal swab sampling, and residents can test themselves at home after buying it back from pharmacies.
Hu Bijie said that if the patient has just been infected with the new crown virus, it may not be detectable through antigen testing. After infection with the new crown virus, when the virus is in the incubation period or early stage, the positive rate of antigen testing is much smaller than that of nucleic acid testing. As patients develop symptoms, the positive rate of antigen testing increases.
"For example, now we screen the speed of close contact and sub-close connection, through nucleic acid testing can screen out positive patients in the incubation period, antigen testing may be a few days later to detect." He said.
He stressed that this also means that antigen testing is meaningful for screening people infected with the new crown virus with a high viral load. "Positive antigen tests are usually people who have a high viral load and are highly contagious, and these people need to take timely measures and confirm the nucleic acid test again."
Source: The Paper
Edit: Bi Yangjing
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