Yesterday (12th), the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, five covid-19 antigen self-test products have been officially launched.
residents can test at home
With the normalization of the epidemic situation, covid-19 detection has become an important part of the epidemic prevention and control. At present, there are three main methods for covid-19 detection: nucleic acid detection, antigen detection and antibody detection. The detection mechanism, detection cost and detection sensitivity of the three methods are different.
Nucleic acid detection has the highest sensitivity and is the “gold standard” for the diagnosis of covid-19 pneumonia. However, the detection requirements are high and the cost is high. Generally, the results are obtained in 24 hours, which takes a long time. The antigen detection operation is simple and convenient, and there is no need for special instruments. Residents can detect by themselves at home, and the results can be issued in 15 minutes. The disadvantage is that it is less sensitive than nucleic acid detection. Antibody detection is similar to antigen detection in operation and time, but it can not detect patients in the infection window.
At present, nucleic acid detection is mainly used in China, while covid-19 detection abroad is mainly antigen detection. Covid-19 antigen detection is mainly to detect some specific proteins of the virus to determine whether the detector is infected; Nucleic acid detection is mainly to detect the nucleic acid gene fragment of covid-19 virus. They detect different targets. Zhang Wenhong, head of the clinical treatment expert group of covid-19 pneumonia in Shanghai and director of the infection department of Huashan Hospital Affiliated to Fudan University, vividly said that the antigen is like the “clothes” worn outside the virus, and the nucleic acid is the gene inside the virus.
The reporter noted that in the covid-19 virus antigen detection application scheme (Trial) (hereinafter referred to as the “trial scheme”) recently released by the comprehensive group of the joint prevention and control mechanism of the State Council, it is mentioned that antigen detection is added as a supplement on the basis of nucleic acid detection.
self test is applicable to three groups
The pilot scheme is clear that there are three categories of people suitable for antigen detection: first, those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms and have symptoms within 5 days; Second, isolate observers, including those in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area; Third, community residents who need antigen self-test.
According to the pilot scheme, community residents who need self-test can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels.
This is also the core significance of the approval of the “self-test application change” by the State Food and drug administration. Industry insiders said that this means that the approved testing reagents are no longer limited to “only used by professional technicians”. The reporter noted that the registration certificate before the change of Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen detection kit stipulates that “the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions”, and this provision will no longer be included in the scope of application / intended use of the product after the registration change. In other words, the relevant testing reagents will no longer be just “professional” products, and the scope of use will be further expanded in the future, or include other scenarios such as home self-test and social health test.
However, the pilot program emphasizes that antigen testing is generally used in the acute infection period, that is, the sample testing within 7 days of the symptoms of the suspected population. The health commission also specifically stated that nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. Antigen detection, as a supplementary means, can be used for screening of specific populations, which is conducive to improving the ability of “early detection”. (Reporter Yuan Lu)
(original title: five covid-19 antigen self-test products. Residents on the market can buy reagents by themselves, and the test results can be issued in 15 minutes)
