Covid-19 antigen detection products that have just been approved will be collected?
In March 14th, the Tianjin pharmaceutical purchasing center issued the notice on centralized maintenance of New Coronavirus antigen detection reagent. It is said that in order to implement the spirit of the State Council’s response to the joint prevention and control mechanism of New Coronavirus pneumonia, the notice on the issuance of COVID-19 virus antigen detection application (Trial Implementation) (joint prevention and control mechanism 2020 [21]), we will further optimize the COVID-19 virus detection strategy and add antigen detection as a supplement on the basis of nucleic acid detection. Tianjin pharmaceutical purchasing center is going to carry out the centralized maintenance of New Coronavirus antigen detection reagent products in March 14th.
The information focused on maintaining the range of varieties is New Coronavirus antigen detection reagent, but it is not clear whether the product is for professional people or home self testing products. The centralized maintenance time of product information is from 15:00 on March 14 to 17:00 on March 18.
According to the notice of Tianjin pharmaceutical procurement center, the enterprise scope of this information maintenance is the medical device registrant (agent) who has obtained the legal qualification of the products within the scope of this procurement. As a maintenance enterprise, he is willing to participate. Among them, the overseas medical device registrant (agent) shall designate an enterprise legal person in China to assist it in performing its corresponding legal obligations and entrust it as a maintenance enterprise. Products with the same medical device registration certificate shall not be entrusted to different enterprises for maintenance.
At present, 10 covid-19 antigen self-test products have been approved in China. On March 12, the State Food and Drug Administration approved the application 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, and five covid-19 antigen self-test products were officially launched. On March 13, the State Food and Drug Administration approved the registration applications of five covid-19 antigen products, namely Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Beijing Hotgen Biotech Co.Ltd(688068) , Tianjin BIOSIS, Chongqing Mingdao Jietai biology and Beijing Lepu diagnostics.
The basic requirements and procedures for covid-19 virus antigen self-test issued by the National Health Commission emphasize that antigen detection is generally used in the period of acute infection, that is, the sample detection within 7 days of symptoms of suspected people. Further nucleic acid detection should be carried out for the antigen positive and negative results of the suspected population. The positive results can be used for the early diversion and rapid management of the suspected population, but can not be used as the basis for the diagnosis of covid-19 virus infection. Nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection.
According to the data on the official website, Tianjin pharmaceutical procurement center was established in August 2011 and is now a public institution subordinate to Tianjin Medical Security Bureau. It is a non-profit and public welfare professional organization in Tianjin that implements the centralized procurement of drugs, medical consumables and medical devices. Its main functions are centralized procurement, data management, decision support, supervision assistance, business consultation, information tracking, complaint investigation and scientific research. It undertakes the daily work of the joint procurement office of high-value medical consumables organized by the state and is responsible for the specific implementation.
Does the maintenance of information mean that covid-19 antigen detection reagent products should be collected?
On the afternoon of March 14, the surging news reporter contacted Tianjin pharmaceutical procurement center as an enterprise. The staff said that they were not responsible for this part of the work and were not sure whether this document was related to centralized procurement. If they met the requirements, they would deal with the participation in accordance with the requirements of the notice.
A staff member of a covid-19 antigen detection product manufacturer said that he saw someone in the industry forwarding the above notice. The specific situation is not clear. However, there is a lot of room for the price reduction of antigen detection products. Surging news previously reported that at present, the pre-sale unit price of e-commerce platforms and offline pharmacies is mostly more than 20 yuan, up to about 30 yuan.
It is worth mentioning that covid-19 antigen detection reagents have been collected before. In May 21, 2021, the Guangdong drug exchange center announced that New Coronavirus (2019-nCoV) test reagent alliance regional group purchased the selected information in quantity, and the Guangzhou Wondfo Biotech Co.Ltd(300482) COVID-19 antigen detection kit won the bid, winning the bid price was 16.8 yuan / person. The main bodies participating in the procurement in the alliance area are Guangdong, Jiangxi, Henan, Hunan, Guangxi, Hainan, Chongqing, Guizhou, Yunnan, Gansu and Qinghai provinces (cities and autonomous regions).
In March 12, 2022, the State Food and Drug Administration issued a circular to approve the registration change of Guangzhou Wondfo Biotech Co.Ltd(300482) New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method). In terms of time, the antigen detection kit won by Guangdong centralized procurement is a product for professionals.
Surging news reporters combed the announcement issued by Tianjin pharmaceutical procurement center and found that after the centralized maintenance of products, many varieties announced the plan of volume procurement, such as the centralized maintenance of medical consumables information of coronary artery dilatation balloon on February 8 this year, and the work plan of volume linkage procurement and use of this category was announced on February 15. On October 27, 2021, the notice on centralized information maintenance of intraocular lens medical consumables was issued, and on November 24, 2021, the work plan for “3 + n” belt quantity linkage procurement and use of this category was announced.
