2016年9月2日,国家食品药品监督管理总局经审查,批准了厦门致善生物科技有限公司生产的“结核分枝杆菌氟喹诺酮类药物耐药突变检测试剂盒(荧光PCR熔解曲线法)”、“结核分枝杆菌链霉素耐药突变检测试剂盒(荧光PCR熔解曲线法)”和“结核分枝杆菌乙胺丁醇耐药突变检测试剂盒(荧光PCR熔解曲线法)”。三个产品都由扩增试剂、对照试剂和提取试剂组成。
上述三个体外诊断试剂是国产同类产品首次获批,分别用于检测结核分枝杆菌对氟喹诺酮类药物耐药性、链霉素药物耐药性或乙胺丁醇药物耐药性,可用于临床上结核病的辅助诊断。这些产品上市,有利于对耐多药结核病患者及时诊治,从而更好地控制与治疗结核病。
食品药品监督管理部门将加强产品上市后监管,保护患者用械安全。
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