Schewe Christiane, Goldmann Torsten, Grosser Marianne, Zink Albert, Schlüns Karsten, Pahl Stefan, Ulrichs Timo, Kaufmann Stefan H E, Nerlich Andreas, Baretton Gustavo B, Dietel Manfred, Vollmer Ekkehard, Petersen Iver
Charité-Campus Mitte, Institute of Pathology, Universitätsmedizin Berlin, Schumannstr. 20-21, 10098 Berlin, Germany.
Virchows Arch. 2005 Sep;447(3):573-85. doi: 10.1007/s00428-005-1233-3. Epub 2005 Jun 21.
The present study is based on the initiative for quality assurance in pathology of the German Society of Pathology and the Professional Association of German Pathologists. Four panel laboratories with experience and expertise in polymerase chain reaction (PCR) detection of Mycobacterium tuberculosis were selected to establish the prerequisites for continuous external laboratory trials, in particular, by providing pre-tested specimens and evaluation criteria for participating institutes. In the first step, the four panel laboratories performed an internal trial to test their own reliability and reproducibility. Paraffin sections and DNA preparations from 34 tissues (25 clinical specimens and 9 controls) totalling to 66 samples were evaluated by each panel institute according to their own protocols. The methodologies differed and are described in detail. Despite these differences, a high degree of inter-laboratory reliability was achieved. In this report, we summarise our results including the correlation with the histology and provide recommendations for applying PCR-based methodology for the detection of mycobacterial DNA in surgical specimens. Supplementary data are available online at http://www.charite.de/ch/patho (rubric "Forschung"). Pre-tested specimens are now available for the external trial and can be ordered from the steering institute via Oligene (http://www.oligene.com/). All molecular pathology laboratories are invited to participate in this quality assurance initiative.
本研究基于德国病理学会和德国病理学家专业协会发起的病理学质量保证项目。挑选了四个在结核分枝杆菌聚合酶链反应（PCR）检测方面有经验和专业知识的参比实验室，以建立持续外部实验室试验的先决条件，特别是通过为参与机构提供预先检测的标本和评估标准。第一步，四个参比实验室进行了内部试验，以测试自身的可靠性和可重复性。每个参比机构根据各自的方案对来自34个组织（25个临床标本和9个对照）的石蜡切片和DNA制剂共66个样本进行了评估。方法各不相同，并进行了详细描述。尽管存在这些差异，但仍实现了高度的实验室间可靠性。在本报告中，我们总结了我们的结果，包括与组织学的相关性，并为在手术标本中应用基于PCR的方法检测分枝杆菌DNA提供了建议。补充数据可在网上获取（http://www.charite.de/ch/patho，“研究”栏目）。现在可获得用于外部试验的预先检测标本，可通过Oligene（http://www.oligene.com/）向指导机构订购。邀请所有分子病理学实验室参与这一质量保证项目。
