罗氏(RHHBY)结核潜伏感染血检Elecsys IGRA TB获欧盟CE认证

金吾财讯
Jul 09

金吾财讯 | 罗氏(RHHBY)宣布,旗下 Elecsys IGRA TB 结核潜伏感染血液检测试剂盒取得欧盟 CE 认证,可搭载公司主流 cobas 化学发光免疫分析仪,为医疗机构提供高通量、全自动化结核筛查方案,助力世卫组织 2030 年结核病消除目标落地。据介绍,该产品采用干扰素释放试验技术,单样本检测仅需 19 分钟,整套流程 24 小时内即可出具完整报告,耗时仅为传统检测手段的一半。全球多中心临床数据显示,对比现行标准检测方法,试剂盒阳性符合率 91.12%、阴性符合率 94.57%;经细菌学确诊结核患者检测相对灵敏度达 100%,低风险人群特异性 95.32%,检测精准度表现优异。相较传统结核皮试,IGRA 血液检测受卡介苗疫苗干扰极小,仅需单次采血就诊,大幅减轻医护操作压力。据悉,该套检测系统配套数字化工具,自动完成结果计算、判读与报告生成,可对接第三方自动分液设备。公司规划将推出一体化前处理自动化设备,进一步压缩人工工作量,且产品可与 cobas MTB、MTB-RIF/INH 分子试剂搭配使用,形成 “潜伏感染筛查 + 活动性结核确诊 + 耐药基因检测” 一体化诊断体系。

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