Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine: Part 4: Tissue Tools for Quality Assurance in Immunohistochemistry

被引：17

作者：

Cheung, Carol C. ^{[1
,2
]}

D'Arrigo, Corrado ^{[7
,8
,9
]}

Dietel, Manfred ^{[13
]}

Francis, Glenn D. ^{[14
,15
,16
]}

Fulton, Regan ^{[17
]}

Gilks, C. Blake ^{[4
]}

Hall, Jacqueline A. ^{[10
,12
]}

Hornick, Jason L. ^{[18
]}

Ibrahim, Merdol ^{[11
]}

Marchetti, Antonio ^{[20
,21
]}

Miller, Keith ^{[11
]}

van Krieken, J. Han ^{[22
]}

Nielsen, Soren ^{[23
,24
,25
]}

Swanson, Paul E. ^{[5
]}

Taylor, Clive R. ^{[19
]}

Vyberg, Mogens ^{[23
,24
,25
]}

Zhou, Xiaoge ^{[26
,27
]}

Torlakovic, Emina E. ^{[1
,3
,6
]}

机构：

[1] Univ Toronto, Dept Lab Med & Pathobiol, Toronto, ON, Canada

[2] Univ Hlth Network, Dept Pathol, Toronto, ON, Canada

[3] Univ Hlth Network, Lab Hematol, Toronto, ON, Canada

[4] Univ British Columbia, Vancouver Gen Hosp, Vancouver, BC, Canada

[5] Univ Calgary, Cumming Sch Med, Dept Pathol & Lab Med, Calgary, AB, Canada

[6] Natl Stand Comm High Complex Testing Immunohistoc, CIQC, Canadian Assoc Pathologists, Kingston, ON, Canada

[7] Poundbury Canc Inst, Dorchester, England

[8] Dorset Cty Hosp NHS Fdn Trust, Dorchester, England

[9] Canc Diagnost Qual Assurance Serv CADQASc, Dorchester, England

[10] Imperial Coll London, Dept Surg & Canc, Div Canc, London, England

[11] UCL, UK NEQAS, London, England

[12] Int Qual Network Pathol IQN Path, Luxembourg, Luxembourg

[13] Charite, Inst Pathol, Sch Med, Berlin, Germany

[14] Griffith Univ, Gold Coast, Australia

[15] Genom Life, Brisbane, Qld, Australia

[16] RCPA Qual Assurance Program, Sydney, NSW, Australia

[17] Phenopath, Seattle, WA USA

[18] Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA

[19] Univ Southern Calif, Keck Sch Med, Los Angeles, CA USA

[20] Ctr Predict Mol Med, Chieti, Italy

[21] Univ G dAnnunzio, Ctr Excellence Ageing & Translat Med, Chieti, Italy

[22] Radboud Univ Nijmegen, Dept Pathol, Med Ctr, Nijmegen, Netherlands

[23] Aalborg Univ Hosp, Inst Pathol, Aalborg, Denmark

[24] Aalborg Univ, Dept Clin Med, Aalborg, Denmark

[25] Nord Immunohistochem Qual Control NordiQC, Aalborg, Denmark

[26] Capital Med Univ, Beijing Friendship Hosp, Dept Pathol, Beijing, Peoples R China

[27] Chinese Comm Pathologists Immunohistochem Qual Co, Beijing, Peoples R China

来源：

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY | 2017年 / 25卷 / 04期

关键词：

immunohistochemistry; quality tools; tissue tools; test development; quality assurance; biomarker; validation; STANDARDIZATION; RECOMMENDATIONS;

D O I：

10.1097/PAI.0000000000000469

中图分类号：

R602 [外科病理学、解剖学]; R32 [人体形态学];

学科分类号：

100101 ;

摘要：

The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order to develop and maintain high quality fit-for-purpose IHC testing in the era of precision medicine. This is the final part of the 4-part series Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine.

引用

页码：227 / 230

页数：4

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