The detection kit of Clostridium difficile from Jiangsu Jianwei Diagnostic Technology. [Photo/WeChat account: weigg6666]
The Clostridium difficile tpi and toxin A and toxin B Gene detection kit (fluorescent PCR method), developed by Jiangsu Jianwei Diagnostic Technology, has obtained the national Class III medical device registration certificate, ranking as the first certified product of its kind in China.
The company is a subsidiary of Jiangsu Cowin Biotech, located in the Taizhou Medical High-tech Zone, Taizhou, Jiangsu province.
So far, Jiangsu Cowin Biotech has accumulated 12 Class III medical device registration certificates. Its products cover multiple popular fields such as early screening of the digestive tract and respiratory infection detection.
Clostridium difficile is an important pathogen causing hospital-acquired diarrhea. For a long time, traditional methods could only determine its presence but not identify whether the bacteria was producing harmful toxins.
The testing kit approved by Jiangsu Cowin Biotech establishes a dual screening mechanism of identity verification and toxicity evaluation for bacteria by synchronously locking the three key gene targets of tpi, toxin A, and toxin B. This can accurately determine if there is Clostridium difficile in the patient's body and whether the bacteria has pathogenic ability.