May the highly anticipated antigen detection reagent be delayed?
A few days ago, some media reported that the people's pharmacy and Guangzhou Wanfu Biological reached a cooperation, the first batch of new crown antigen rapid test products have been in the logistics and transportation, the first batch of products will be sold in the people's pharmacy stores.
The first financial reporter 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, and the pharmacies here in Shanghai still need to build a new catalog and be approved by the superior before they can be put into storage; some pharmacies also need to handle the qualification to sell this product, which needs to go to the food and drug administration for the record, "it is expected to take 2 weeks to buy on the shelves."
The reporter also learned from an industry insider that at present, Wanfu Bio has been required to temporarily remove the shelves in the OTC channel due to the fact that it has not replaced the instructions for antigen detection reagents, and will be re-listed after replacing the product manual.
At 22:58 on the evening of the 12th, Wanfu Biological Official Micro issued a "solemn statement", saying, "For individuals and companies that claim to be able to sell the new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) products developed by our company without the legal authorization of our company, through e-commerce and other online channels without authorization, our company reserves the right to report the case to the relevant public security departments and pursue corresponding legal responsibilities." ”
At 23:15, the official public account of the State Food and Drug Administration,"China Pharmaceutical News", also issued the "Notice of the Comprehensive 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 that "the focus is on whether the new coronavirus antigen testing reagents operated by enterprises are registered and approved and have qualified certification documents, and whether the product specifications indicate the consumer's personal use instructions."
The above-mentioned industry insiders said that because these antigen detection products were previously sold to enterprises, this time to sell to individuals, it is necessary to change the description of the product manual, and it will take a period of time to complete the change, "Several companies may need to update the new crown antigen testing product manual."
The reporter then called wanfu bio several times to contact the secretary of the board of directors of Wanfu Biology and was not connected. Feng Shini, secretary of the board of directors of the People's Pharmacy, responded to reporters that whether Wanfu Bio's new crown antigen self-test products are not known, and the details must be communicated with the procurement department before replying, and according to the arrangement, the product should be directly operated and sold at the Shanghai directly operated and sales qualification store of the People's Big Pharmacy as soon as 14.
A number of disease control experts told First Finance 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 focused on the outbreak area.