A document from the National Health Commission has completely opened up the imagination of covid-19 antigen detection and home self-test in China.
On the 11 day, the national Wei Jian administration official website issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation). It indicated that in order to further optimize the COVID-19 virus detection strategy, according to the epidemic prevention and control needs, the State Council should decide on the basis of nucleic acid detection on the basis of the comprehensive group of New Coronavirus pneumonia epidemic prevention and control mechanism integrated group. Antigen detection was added as a supplement , and covid-19 virus antigen detection application scheme (Trial) (hereinafter referred to as the “scheme”) was organized and formulated.
Figure | application scheme for covid-19 virus antigen detection (Trial); Source: National Health Commission website
this means that the demand for covid-19 antigen detection in China will finally be opened
Public information shows that covid-19 detection mainly includes three detection methods: nucleic acid, antibody and antigen. Among them, nucleic acid detection is the “gold standard” for the diagnosis of covid-19 virus, which has been the preferred covid-19 screening method in China since the emergence of the epidemic.
“The main advantage of nucleic acid detection is that it is more convenient and fast.” Some securities analysts summarized the differences and characteristics of the two detection methods.
However, even if the application of antigen detection will be expanded in the future, it should be noted that the National Health Commission still emphasizes that “nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection.”
in addition, it is worth mentioning that the plan released by the health commission also defines the relevant policies for home self-test of covid-19 virus antigen for the first time, which has aroused heated discussion in the market
according to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels at the same time, the plan also standardized the “basic requirements and process of covid-19 virus antigen self-test” and issued it in the form of attachment.
Figure | application scheme for covid-19 virus antigen detection (Trial); Source: National Health Commission website
however, this does not mean that the antigen home self-test has arrived
according to the reporter of science and Innovation Board daily, although there are covid-19 antigen detection reagents approved for marketing in China, there is no covid-19 antigen self-test kit approved, and there is no covid-19 antigen kit available for home self-test in retail pharmacies and online sales platforms
Up to now, the subsidiaries of Huafu Technology (Shenzhen) Co., Ltd. (SZ) have been approved by Beijing Huafu Biotechnology Co., Ltd. (sz-3006) and SZ Bio Technology Co., Ltd., respectively.
” these four products belong to the ‘professional version’, not the ‘self-test version’. Only with the ‘self-test qualification’ can they be sold in retail pharmacies and other channels. ” insiders told the reporter of the science and Innovation Board daily.
The other side’s statement was confirmed by another industry insider. ” although our products are close to home self-test products in operation, they still have no (self-test) qualification. Only after they are obtained can they be (sold in pharmacies) .” Guangzhou Wondfo Biotech Co.Ltd(300482) relevant people said.
It is reported that the technical platforms of covid-19 antigen detection reagent mainly include fluorescence immunochromatography and colloidal gold method. “Among them, fluorescence method products need supporting instruments, while colloidal gold method products do not need supporting instruments. Similar home detection products can be operated by users themselves”.
At present, among the four covid-19 antigen detection reagents approved for marketing in China, Guangzhou Wondfo Biotech Co.Ltd(300482) the new coronavirus (2019 ncov) antigen detection kit belongs to the colloidal gold method. In addition, Shenzhen Huada Yinyuan and Beijing huaketai products are fluorescence method, and Beijing jinwofu is emulsion method.
however, covid-19 antigen reagent for home self-test may also be approved for marketing soon . ” at present, relevant departments are accelerating the registration and approval of self-test products, and many enterprises have applied for ‘self-test qualification’, including Wanfu, Andon Health Co.Ltd(002432) ( Andon Health Co.Ltd(002432) . SZ) and .” The reporter of science and technology innovation board daily learned from many channels.
Therefore, before the home self-test is really started, the covid-19 antigen detection in China is still mainly limited to professional institutions and specific populations.
According to the plan released by the National Health Commission on the 11th, the first group of people suitable for antigen testing is also those who go to grass-roots health and medical institutions with respiratory tract, fever and other symptoms and have symptoms within 5 days.
In addition, the plan focuses on the detailed description of how grass-roots medical and health institutions carry out antigen testing, including the provisions that grass-roots medical and health institutions need to meet the following conditions at the same time:
1. The sample collection and testing personnel shall receive biosafety training and technical operation training, and pass the examination;
2. Have appropriate instruments and equipment such as biosafety cabinet, and protect medical personnel during testing;
3. The detection operation should be carried out in a relatively independent and well ventilated space; Primary medical and health institutions with laboratory conditions are encouraged to carry out testing operations in the laboratory;
4. Establish the report, transportation system and work flow of antigen positive personnel.
