Jiangsu Cowin Biotech (688426.SH): Difficult Clostridium Glutamate Dehydrogenase Antigen and Toxin Detection Kit (Enzyme-linked Immunosorbent Assay) Obtains Medical Device Registration Certificate.

Jiangsu Cowin Biotech (688426.SH) announced that its wholly-owned subsidiary Jiangsu Jianwei Diagnostic Technology Co., Ltd. (referred to as "Jianwei Diagnostic") has independently developed a Clostridium difficile glutamate dehydrogenase antigen and toxin detection kit (enzyme-linked immunosorbent assay) which has been awarded Class III "Medical Device Registration Certificate (In-Vitro Diagnostic Reagent)" by the National Medical Products Administration. Jianwei Diagnostic's independently developed digestive tract pathogen detection product "Clostridium difficile glutamate dehydrogenase antigen and toxin detection kit (enzyme-linked immunosorbent assay)" combines the technologies of immunochromatography and enzyme-linked amplification reaction to quickly qualitatively detect Clostridium difficile glutamate dehydrogenase (GDH) and toxins A/B in fecal samples. This test kit combines GDH broad screening with toxin-specific validation to achieve "one-step operation, dual-target synchronous detection," which helps clinically differentiate between asymptomatic colonization and active infection of Clostridium difficile, achieving precise differential diagnosis.