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Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine - Part 2: Immunohistochemistry Test Performance Characteristics

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单位: [1]Department of Laboratory Medicine and Pathobiology, University of Toronto, Vancouver, BC, Canada [2]Department of wLaboratory Hematology, University Health Network, Toronto, ON, Canada [3]Department of Pathology, University Health Network, Toronto, ON, Canada [4]Canadian Immunohistochemistry Quality Control (CIQC)/ Canadian Association of Pathologists National Standards Committee for High Complexit Testing/Immunohistochemistry [5]Poundbury Cancer Institute [6]Dorset County Hospital NHS Foundation Trust [7]Cancer Diagnostic Quality Assurance Services (CADQAScic), Dorchester, UK [8]UK National External Quality Assessment Scheme (UK NEQAS), University College London, London, UK [9]“Rudolf-Virchow-Haus”, Institute of Pathology, Charite′—University Hospital Berlin, Berlin, Germany [10]School of Medicine, Griffith University, Gold Coast [11]Genomics For Life, Brisbane, QLD [12]RCPA Quality Assurance Program, Sydney, NSW, Australia [13]Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada [14]International Quality Network for Pathology (IQN Path), Luxembourg City, Luxembourg, and Division of Cancer, Department of Surgery & Cancer, Imperial College London, UK [15]Brigham and Women’s Hospital, Harvard Medical School, Boston, MA [16]Center of Predictive Molecular Medicine, Center for Excellence on Ageing and Translational Medicine, University of Chieti-Pescara, Chieti, Italy [17]Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands [18]Institute of Pathology, Aalborg University Hospital and Department of Clinical Medicine, Aalborg University, Denmark [19]Nordic Immunohistochemistry Quality Control (NordiQC), Aalborg, Denmark [20]Department of Pathology and Laboratory Medicine, Cumming School of Medicine, University of Calgary and Calgary Laboratory Services, Calgary, AB [21]Department of Pathology, Beijing Friendship Hospital, Capital Medical University [22]CCPIHCQC, Chinese Committee for Pathologists—Immunohistochemistry Quality Control, Beijing, China [23]Keck School of Medicine, University of Southern California, Los Angeles, CA
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关键词: biomarkers quality assurance quality control validation immunohistochemistry test performance characteristics

摘要:
All laboratory tests have test performance characteristics (TPCs), whether or not they are explicitly known to the laboratorian or the pathologist. TPCs are thus also an integral characteristic of immunohistochemistry (IHC) tests and other in situ, cell-based molecular assays such as DNA or RNA in situ hybridization or aptamer-based testing. Because of their descriptive, in situ, cell-based nature, IHC tests have a limited repertoire of appropriate TPCs. Although only a few TPCs are relevant to IHC, proper selection of informative TPCs is nonetheless essential for the development of and adherence to appropriate quality assurance measures in the IHC laboratory. This paper describes the TPCs that are relevant to IHC testing and emphasizes the role of TPCs in the validation of IHC tests. This is part 2 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 3 区 解剖学与形态学 3 区 医学实验技术 4 区 病理学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 解剖学与形态学 4 区 医学实验技术 4 区 病理学
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出版当年[2015]版:
Q1 ANATOMY & MORPHOLOGY Q3 PATHOLOGY Q3 MEDICAL LABORATORY TECHNOLOGY
最新[2023]版:
Q2 ANATOMY & MORPHOLOGY Q3 MEDICAL LABORATORY TECHNOLOGY Q3 PATHOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2015版] 出版当年五年平均[2011-2015] 出版前一年[2014版] 出版后一年[2016版]

第一作者:
第一作者单位: [1]Department of Laboratory Medicine and Pathobiology, University of Toronto, Vancouver, BC, Canada [2]Department of wLaboratory Hematology, University Health Network, Toronto, ON, Canada [4]Canadian Immunohistochemistry Quality Control (CIQC)/ Canadian Association of Pathologists National Standards Committee for High Complexit Testing/Immunohistochemistry [*1]Department of Laboratory Hematology, Toronto General Hospital/UHN, 200 Elizabeth Street, Toronto, ON, Canada M5G 2C4
通讯作者:
通讯机构: [1]Department of Laboratory Medicine and Pathobiology, University of Toronto, Vancouver, BC, Canada [2]Department of wLaboratory Hematology, University Health Network, Toronto, ON, Canada [4]Canadian Immunohistochemistry Quality Control (CIQC)/ Canadian Association of Pathologists National Standards Committee for High Complexit Testing/Immunohistochemistry [*1]Department of Laboratory Hematology, Toronto General Hospital/UHN, 200 Elizabeth Street, Toronto, ON, Canada M5G 2C4
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