The highly anticipated antigen detection reagent may be delayed on the shelves?
A few days ago, it was reported by the media that People's Pharmacy and Guangzhou Wanfu Biological have reached a cooperation. The first batch of new crown antigen rapid test products have been in the process of logistics and transportation, and the first batch of products will be sold in the stores of People's Pharmacy.
A reporter from China Business News called a large pharmacy store in Shanghai today to inquire, and got a reply that Wanfu Bio's new crown antigen self-test products are still in the large warehouse of Hunan headquarters. It can be put into storage; some pharmacies also need to apply for the qualification to sell this product, which requires filing with the drug administration bureau.
The reporter also learned from an industry insider that Wanfu Bio has been asked to temporarily remove the product from the OTC channel because it has not replaced the instruction manual of the antigen detection reagent.
At 22:58 on the evening of the 12th, Wanfu Bio's official Weibo issued a "solemn statement" saying, "For the new coronavirus developed by our company that has not been legally authorized by our company and claimed to be sold through e-commerce and other online channels. For individuals and companies producing virus (2019-nCoV) antigen detection kits (colloidal gold method) products, our company reserves the right to report the case to the relevant public security departments and pursue corresponding legal responsibilities."
At 23:15 after that, the official public account of the State Food and Drug Administration "China Pharmaceutical News" also released the "Notice of the General Department of the State Food and Drug Administration on Doing a Good Job in the Quality and Safety Supervision of New Coronavirus Antigen Detection Reagents", saying, "Focus on enterprises Whether the new coronavirus antigen detection reagents operated by the company have been approved for registration and have qualified certification documents, and whether the product manual contains instructions for personal use by consumers, etc.”
The above-mentioned industry insiders said that since these antigen detection products were previously sold to enterprises, this time, if they are to be sold to individuals, the description of the product manual needs to be changed, and it will take some time for the changes to be completed. Check the update of the product manual".
The reporter then contacted the secretary of the board of directors of Wanfu Biotechnology many times but was not answered.
Feng Shini, the secretary of the board of directors of the pharmacy of the common people, responded to the reporter that it is not known whether the new crown antigen self-test product of Wanfu Bio has this problem, and the details need to be communicated with the purchasing department before replying. As soon as the 14th, it will be put on the shelves in Shanghai's direct-operated and qualified stores of the People's Pharmacy.
Several disease control experts told Yicai that the "antigen screening + nucleic acid diagnosis" method should be the general trend in the next period, and the new crown antigen self-test products will also be put on focus in the outbreak area.