Kang Wei Century (688426.SH): Clostridium Difficile TPI and Toxin A and Toxin B genetic test kit (fluorescence PCR method) obtained registration certificates for three types of medical devices

Zhitong Finance App News, Kangwei Century (688426.SH) issued an announcement. Recently, the company's wholly-owned subsidiary Jiangsu Jianwei Diagnostic Technology Co., Ltd. (“Jianwei Diagnosis”) independently developed a C. difficile TPI and toxin A and toxin B genetic test kit (fluorescence PCR method) obtained a Class III “Medical Device Registration Certificate (in vitro diagnostic reagent)” issued by the China Drug Administration.

The digestive pathogen detection product “Clostridioidesdifficult TPI and toxin A and toxin B gene detection kit (fluorescence PCR method)” was developed independently by Jianwei. Using fluorescence PCR technology, specific sequences of the TPI, tCDA, and tcdB genes in the Clostridioidesdifficult (Clostridioidesdifficult) genome were designed separately, and specific primers and probes were designed separately to amplify and test them by multiple PCR. The product assists in clinical diagnosis of C. difficile infections through simultaneous testing of tpi, tcDA, and tcdB genes in stool samples.