下呼吸道感染相关的细菌联检产品的适用人群为哪些患者20250228
引起下呼吸道感染的常见细菌一般为肺炎链球菌、流感嗜血杆菌、肺炎克雷伯菌、卡他莫拉菌、鲍曼不动杆菌、嗜麦芽窄食单胞菌、洋葱伯克霍尔德菌等。病原体的致病力存在差别,因此不同的细菌组合检测针对的适用人群不同。
肺炎链球菌、流感嗜血杆菌、肺炎克雷伯菌等为相应致病力较强的病原体,而卡他莫拉菌、鲍曼不动杆菌、嗜麦芽窄食单胞菌、洋葱伯克霍尔德菌等为相应致 病力较弱的病原体。针对致病力较强的病原体组合,或致病力较强病原体与致病力较弱的病原体的组合,适用人群一般为疑似下呼吸道感染的人群,包括支气管 炎、肺炎患者。对于嗜肺军团菌,一般可导致肺炎,如组合中包括嗜肺军团菌,适用人群一般为肺炎患者。如均为致病力较弱的病原体组合,适用人群一般为临床 呼吸系统感染重症、结构性肺病等人群,检测结果还应结合被测病原体载量及其他致病力较强的病原体检测结果等综合判断。
申请人应考虑病原体组合所针对的适用人群,入组相应的病例进行临床评价。
临床与生物统计二部
发布时间:2025-02-28
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