Standardization of Positive Controls in Diagnostic Immunohistochemistry: Recommendations From the International Ad Hoc Expert Committee

被引：92

作者：

Torlakovic, Emina E. ^{[1
,5
]}

Nielsen, Soren ^{[6
,7
]}

Francis, Glenn ^{[8
,9
,10
]}

Garratt, John ^{[2
,5
]}

Gilks, Blake ^{[3
,5
]}

Goldsmith, Jeffrey D. ^{[11
]}

Hornick, Jason L. ^{[1
,12
]}

Hyjek, Elizabeth ^{[1
]}

Ibrahim, Merdol ^{[13
]}

Miller, Keith ^{[13
]}

Petcu, Eugen ^{[8
]}

Swanson, Paul E. ^{[4
,14
]}

Zhou, Xiaoge ^{[15
,16
]}

Taylor, Clive R. ^{[17
]}

Vyberg, Mogens ^{[6
,7
]}

机构：

[1] Univ Toronto, Dept Lab Hematol, Toronto Gen Hosp, Univ Hlth Network, Toronto, ON M5G 2C4, Canada

[2] Vancouver Costal Hlth, Vancouver, BC, Canada

[3] Univ British Columbia, Vancouver Gen Hosp, Vancouver, BC V5Z 1M9, Canada

[4] Univ Calgary, Dept Pathol, Calgary, AB, Canada

[5] Canadian Immunohistochem Qual Control CIQC, Vancouver, BC, Canada

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

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

[8] Griffith Univ, Sch Med, Nathan, Qld 4111, Australia

[9] Univ Queensland, Australian Inst Bioengn & Nanotechnol, Brisbane, Qld 4072, Australia

[10] RCPA QAP Pty Ltd, Convenor Immunohistochem, Anat Pathol Program, Sydney, NSW, Australia

[11] Beth Israel Deaconess Med Ctr, Boston, MA USA

[12] Harvard Univ, Brigham & Womens Hosp, Sch Med, Boston, MA 02115 USA

[13] UCL, UK Natl External Qual Assessment Scheme UK NEQAS, London, England

[14] Univ Washington, Seattle, WA 98195 USA

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

[16] Chinese Comm Pathol Immunohistochem Qual Control, Qingdao, Peoples R China

[17] Univ So Calif, Keck Sch Med, Los Angeles, CA 90033 USA

来源：

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY | 2015年 / 23卷 / 01期

关键词：

immunohistochemistry; standardization; positive controls; iCAPCs; methodology transfer; prognostic and predictive biomarkers; ANTIGEN-RETRIEVAL TECHNIQUE; CLINICAL ONCOLOGY/COLLEGE; AMERICAN SOCIETY; TISSUE-SECTIONS; EXPRESSION; VALIDATION; GUIDELINES; IDENTIFICATION; PATHOLOGY; FIXATION;

D O I：

10.1097/PAI.0000000000000163

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：

Diagnostic immunohistochemistry (dIHC) has been practiced for several decades, with an ongoing expansion of applications for diagnostic use, and more recently for detection of prognostic and predictive biomarkers. However, standardization of practice has yet to be achieved, despite significant advances in methodology. An Ad Hoc Expert Committee was formed to address the standardization of controls, which is a missing link in demonstrating and assuring standardization of the various components of dIHC. This committee has also developed a concept of immunohistochemistry critical assay performance controls that are intended to facilitate methodology transfer and harmonization in dIHC. Furthermore, the committee has clarified definitions of IHC assay sensitivity and specificity, with special emphasis on how these definitions apply to positive controls. Recommendations for "best laboratory practice" regarding positive controls for dIHC are specified. The first set of immunohistochemistry critical assay performance controls for several frequently used IHC stains or tests is also developed and presented.

引用

页码：1 / 18

页数：18

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