On March 12, 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
the first batch of “self-test version” covid-19 antigen detection kit is coming! Home self-test shows that there may be a quick action of retail pharmacies
The covid-19 antigen detection kit that can be used for “home self-test” has finally come.
According to CCTV news, on March 12, the State Food and Drug Administration issued a notice approving Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) . SH), Beijing jinwofu Bioengineering Technology Co., Ltd. (hereinafter referred to as “Beijing jinwofu”), Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) . SZ) subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Huada Yinyuan”), Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) . SZ) Application for change of covid-19 antigen product self-test application of Beijing huaketai Biotechnology Co., Ltd. (hereinafter referred to as “Beijing huaketai biotechnology”) since then, five domestic covid-19 antigen self-test products have been officially listed in China
According to “science and board daily” reporter query, the national drug regulatory bureau website issued 11 medical device approval documents (change) to receive information shows, Beijing Hua Ke Tai biological New Coronavirus (2019-nCoV) antigen detection kit (fluorescence immunochromatography) through the registration information of the drug administration to change .
Figure source | official website of the State Food and Drug Administration
According to the information to be received in the approval document (change) for medical devices released on the website of the State Food and Drug Administration on the 12th, the 4 covid-19 antigen detection kits developed by Guangzhou Wondfo Biotech Co.Ltd(300482) , Huada Yinyuan, Beijing jinwofu and Nanjing Vazyme Biotech Co.Ltd(688105) 4 companies have passed the registration information change of the State Food and Drug Administration .
Figure source | official website of the State Food and Drug Administration
The reporter of the science and Innovation Board daily confirmed from multiple channels that the core of this “registration change” is that the relevant testing reagents are no longer limited to “only used by professional technicians” .
For example, Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen detection kit’s registration certificate before change stipulates that “the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions”, and the scope of application / intended use of the product after registration change will no longer include this provision.
Figure | the registration certificate before the change of the covid-19 antigen detection kit of Huada Yinyuan also stipulates that the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions.
Insiders analyzed to the reporter of the science and Innovation Board daily that although the “registration change” did not clearly indicate that it can be used for “home self-test”, no longer limited the relevant testing reagents to “only be used by professional technicians”, which also means that the relevant testing reagents are no longer just “professional” products, and their scope of use will be further expanded, Including other scenes that can be used for home self-test, social health test and so on
It is worth noting that the above five covid-19 antigen detection kits are actually different. From the technical point of view, Guangzhou Wondfo Biotech Co.Ltd(300482) and Nanjing Vazyme Biotech Co.Ltd(688105) ‘s New Coronavirus (2019-nCoV) antigen detection kit adopts colloidal gold method, and Beijing’s gold leaf is latex method. Hua Dayin source and Beijing Hua Ke Tai biology are fluorescent immunochromatography.
” colloidal gold method and latex method do not need supporting instruments. Similar home testing products can be operated by users themselves, so they are more suitable for home self testing .” The aforementioned insiders believe that.
“We think that vid-19 will be more convenient for the detection of antigen in the community-based medical centers, and we expect that vid-19 will be more suitable for the detection of antigen in the community-based medical centers in the future.” The other Party pointed out at the same time.
In addition, it is worth mentioning that, yesterday (11), the Wei Jian official website of the state officially issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation). It indicated that after the study, the State Council responded to the New Coronavirus pneumonia epidemic prevention and control mechanism integrated group, and decided to add antigen detection as a supplement on the basis of nucleic acid detection. It also organized and formulated the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the “scheme”).
The program defines the relevant policies of covid-19 virus antigen self-test for the first time according to the plan, community residents who need covid-19 self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels
However, at that time, a number of business people told the reporter of the science and Innovation Board daily that covid-19 antigen detection reagent can only be sold in retail pharmacies and other channels after obtaining the “self-test qualification”.
Now, “the test reagent after registration change” is no longer limited to “only used by professional technicians”, and its scope of use is further expanded. It also has “self-test qualification”, which means that it has the qualification to sell in retail pharmacies and online sales platforms .
“we have started to act.” Insiders of a chain drugstore in South China told the “science and Innovation Board daily” reporter, “we will reach a ‘starting’ agreement with the antigen reagent manufacturer as soon as possible to win the management right of the other party’s products.”
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