Validating whole slide imaging for diagnostic purposes in Pathology: Guideline from the College of American pathologists Pathology and Laboratory Quality Center

PantanowitzL.; SinardJ.H.; HenricksW.H.FathereeL.A.CarterA.B.ContisL.BeckwithB.A.EvansA.J.OtisC.N.LalA.ParwaniA.V.

首页> 外文期刊>Archives of pathology & laboratory medicine >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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Validating whole slide imaging for diagnostic purposes in Pathology: Guideline from the College of American pathologists Pathology and Laboratory Quality Center

机译：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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Context: 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. Objective: To recommend validation requirements for WSI systems to be used for diagnostic purposes. Design: 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. Results: 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. Conclusions: 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.

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《Archives of pathology & laboratory medicine》 |2013年第12期|1710-1722|共13页
作者
PantanowitzL.; SinardJ.H.; HenricksW.H.FathereeL.A.CarterA.B.ContisL.BeckwithB.A.EvansA.J.OtisC.N.LalA.ParwaniA.V.;
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Department of Pathology, University of Pittsburgh, Medical Center, 5150 Centre Ave, Pittsburgh, PA;

Department of Pathology, Yale University, School of Medicine, New Haven, CT, United States;

Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH, United StatesCollege of American Pathologists, Northfield, IL, United StatesDepartment of Pathology, Laboratory Medicine, Emory University, Atlanta, GA, United StatesDepartment of Pathology, North Shore Medical Center, Salem, MA, United StatesLaboratory Medicine Program, University Health Network, Toronto, ON, CanadaDepartment of Pathology, Baystate Medical Center, Tufts University, Springfield, MA, United StatesUniversity Hospital, London Health Science Center, London, ON, Canada;

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中图分类病理学;
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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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