Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center.
Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center.
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DOI：
10.5858/arpa.2013-0093-cp
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发表时间：
2013-12
影响因子：
4.6
通讯作者：
College of American Pathologists Pathology and Laboratory Quality Center
中科院分区：
文献类型：
--
作者：
Pantanowitz L;Sinard JH;Henricks WH;Fatheree LA;Carter AB;Contis L;Beckwith BA;Evans AJ;Lal A;Parwani AV;College of American Pathologists Pathology and Laboratory Quality Center
将全玻片成像(WSI)用于诊断目的(初级和/或会诊)的兴趣日益浓厚。一个重要的考虑是，WSI是否可以安全地取代传统的光学显微镜，作为病理学家审查组织切片、细胞学切片和/或血液学切片进行诊断的方法。验证WSI对于确保基于数字化载玻片的诊断性能至少与玻片和光学显微镜的诊断性能相当至关重要。目前，没有关于用于诊断的WSI验证的标准指南。建议用于诊断目的的WSI系统的验证要求。美国病理学家学院病理学和实验室质量中心召集了一个来自北美的具有数字病理学专业知识的非供应商小组来制定这些验证建议。进行了文献审查，确定了符合检索条件要求的767种国际出版物。超出这一努力范围的研究和那些仅与技术要素、教育和图像分析有关的研究被排除在外。共有27种出版物进行了评级，并进行了数据提取以进行证据评估。建议是从23项已发表的研究中确定的证据强度、公开评论反馈和专家小组共识中得出的。建立了12个指南声明，以帮助病理实验室验证他们自己的用于临床的WSI系统。整个WSI系统的验证，包括经过培训的使用该系统的病理学家，应该以模拟实验室实际临床环境的方式进行。建议这样的验证性研究包括每个应用程序至少60个常规病例，比较至少相隔2周查看的数字化和玻璃片之间的观察者内部诊断一致性。重要的是，验证过程确认要扫描的玻璃片上存在的所有材料都包括在数字图像中。验证应表明，正在审查的WSI系统产生了可接受的用于诊断解释的数字幻灯片。验证WSI系统的目的是允许在不影响患者护理的情况下临床使用这项技术。
There is increasing interest in using whole slide imaging (WSI) for diagnostic purposes (primary and/or consultation). An important consideration is whether WSI can safely replace conventional light microscopy as the method by which pathologists review histologic sections, cytology slides, and/or hematology slides to render diagnoses. Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy. Currently, there are no standard guidelines regarding validation of WSI for diagnostic use. To recommend validation requirements for WSI systems to be used for diagnostic purposes. The College of American Pathologists Pathology and Laboratory Quality Center convened a nonvendor panel from North America with expertise in digital pathology to develop these validation recommendations. A literature review was performed in which 767 international publications that met search term requirements were identified. Studies outside the scope of this effort and those related solely to technical elements, education, and image analysis were excluded. A total of 27 publications were graded and underwent data extraction for evidence evaluation. Recommendations were derived from the strength of evidence determined from 23 of these published studies, open comment feedback, and expert panel consensus. Twelve guideline statements were established to help pathology laboratories validate their own WSI systems intended for clinical use. Validation of the entire WSI system, involving pathologists trained to use the system, should be performed in a manner that emulates the laboratory’s actual clinical environment. It is recommended that such a validation study include at least 60 routine cases per application, comparing intraobserver diagnostic concordance between digitized and glass slides viewed at least 2 weeks apart. It is important that the validation process confirm that all material present on a glass slide to be scanned is included in the digital image. Validation should demonstrate that the WSI system under review produces acceptable digital slides for diagnostic interpretation. The intention of validating WSI systems is to permit the clinical use of this technology in a manner that does not compromise patient care.