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批准快速链球菌聚合酶链反应用于传统临床实验室以外的检查

By LabMedica International staff writers
Posted on 27 Jul 2015

图片：Cobas Liat系统设计为一个快速、易用、紧凑的PCR系统（照片由Roche提供）。

图片：Cobas Liat系统设计为一个快速、易用、紧凑的PCR系统（照片由Roche提供）。

Cobas Liat系统是一种耗时15分钟的诊断检查，用于检测咽喉培养物中的甲型链球菌（Strep A），此检查在一种已获得美国食品和药品管理局临床检验改进修正计划（CLIA）豁免的用户友好自动PCR平台上运行。
CLIA豁免允许在非传统实验室地点进行Roche（Basel，Switzerland）cobas Liat系统Strep A检验，包括医师办公室、急诊室、保健诊所、药学临床和其他医疗机构。
Cobs Liat系统是一种快速、易用、紧凑的PCR平台，设计用于床旁按需检查，如医师办公室、药房、以及医院和卫星实验室。此系统配备全自动触摸屏导引操作，操作者需要接受的培训量最少，随时可以使用。该系统包括cobas Liat分析仪——一种小巧的台式分析仪，由一组广泛的仪器保护，并组合了越来越多的检测方法，包括cobas甲型/乙型流感、cobas甲型/乙型流感和RSV，以及Cobas Strep A。
“今天的决定允许在此前依赖快速抗原技术的临床环境中使用cobas Strep A检验，原本使用的技术灵敏度较低，常需要进行确证检验，”Roche Diagnostics的首席运营官，Roland Diggelmann说明。“Cobas Strep A检查大约需要15分钟的时间出具报告，相对于需要使用培养物进行检查要经过数天才能得出结果的情况而言，新的方法改善了患者和专业医疗人员的临床经验。”

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