智通财经APP讯，康为世纪(688426.SH)发布公告，近日，公司全资子公司江苏健为诊断科技有限公司(以下简称“健为诊断”)自主研发的艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒(酶联免疫层析法)获得国家药品监督管理局颁发的Ⅲ类《医疗器械注册证(体外诊断试剂)》。
健为诊断自主研发的消化道病原体检测产品“艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒(酶联免疫层析法)”，采用免疫层析与酶联放大反应相结合技术，可在体外对粪便样本中的艰难梭菌谷氨酸脱氢酶(GDH)及毒素A/B进行快速定性检测。该试剂盒将GDH广谱筛查与毒素特异性验证相结合，实现“一步操作、双靶标同步检测”，有助于临床快速区分艰难梭菌无症状定植与活动性感染，实现精准鉴别诊断。
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