Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories
单位：[1]Department of Laboratory Medicine and Pathobiology, University of Toronto[2]Departments of †Laboratory Hematology[3]Pathology, University Health Network, Toronto, ON[4]Vancouver General Hospital, University of British Columbia, Vancouver, BC[5]Department of Pathology and Laboratory Medicine, Cumming School of Medicine University of Calgary, and Calgary Laboratory Services, Calgary, AB, Canada[6]Canadian Immunohistochemistry Quality Control (CIQC), Vancouver, BC, Canada/Canadian Association of Pathologists National Standards Committee for High Complexity Testing/Immunohistochemistry[7]Poundbury Cancer Institute[8]Dorset County Hospital NHS Foundation Trust, Dorchester, UK[9]Cancer Diagnostic Quality Assurance Services (CADQAScic), Dorchester[10]UK National External Quality Assessment Scheme (UK NEQAS), University College London, London, UK[11]School of Medicine, Institute of Pathology, Charité—University Hospital, Berlin, Berlin, Germany[12]Griffith University, Gold Coast[13]RCPA Quality Assurance Program, Sydney[14]Genomics For Life, Brisbane, Australia[15]International Quality Network for Pathology (IQN Path), Luxembourg City, Luxembourg[16]Brigham and Women’s Hospital, Harvard Medical School, Boston, MA[17]Center of Predictive Molecular Medicine, Center for Excellence on Ageing and Translational Medicine, University of Chieti-Pescara, Chieti, Italy[18]Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands[19]Institute of Pathology, and Department of Clinical Medicine, Aalborg University, Aalborg University Hospital[20]Nordic Immunohistochemistry Quality Control (NordiQC), Aalborg, Denmark[21]Department of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing医技科室病理科病理科首都医科大学附属北京友谊医院[22]Chinese Committee for Pathologists—Immunohistochemistry Quality Control, China[23]Keck School of Medicine, University of Southern California, Los Angeles, CA
Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are "fit-for-purpose." Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."
第一作者单位：[1]Department of Laboratory Medicine and Pathobiology, University of Toronto[2]Departments of †Laboratory Hematology[6]Canadian Immunohistochemistry Quality Control (CIQC), Vancouver, BC, Canada/Canadian Association of Pathologists National Standards Committee for High Complexity 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[2]Departments of †Laboratory Hematology[6]Canadian Immunohistochemistry Quality Control (CIQC), Vancouver, BC, Canada/Canadian Association of Pathologists National Standards Committee for High Complexity Testing/Immunohistochemistry[*1]Department of Laboratory Hematology, Toronto General Hospital/UHN, 200 Elizabeth Street, Toronto, ON, Canada M5G 2C4
推荐引用方式(GB/T 7714)：
Torlakovic Emina E.,Cheung Carol C.,D'Arrigo Corrado,et al.Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories[J].APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY.2017,25(3):151-159.doi:10.1097/PAI.0000000000000470.
APA：
Torlakovic, Emina E.,Cheung, Carol C.,D'Arrigo, Corrado,Dietel, Manfred,Francis, Glenn D....&From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path).(2017).Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY,25,(3)
MLA：
Torlakovic, Emina E.,et al."Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories".APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY 25..3(2017):151-159
