A UK NEQAS ISH Multicenter Ring Study Using the Ventana HER2 Dual-Color ISH Assay

被引：35
|
作者：
Bartlett, J. M. S. [1 ,2 ]
Campbell, Fiona M.
Ibrahim, Merdol [2 ]
O'Grady, Anthony [3 ]
Kay, Elaine [3 ]
Faulkes, Catherine [4 ]
Collins, Nadine [4 ]
Starczynski, Jane [5 ]
Morgan, John M. [6 ]
Jasani, Bharat [6 ]
Miller, Keith [2 ]
机构：
[1] Univ Edinburgh, Western Gen Hosp, Endocrine Canc Grp, Canc Res Ctr, Edinburgh EH4 2XR, Midlothian, Scotland
[2] UCL, UK Natl External Qual Assessment Scheme, London, England
[3] Beaumont Hosp, Dept Histol, Dublin 9, Ireland
[4] Univ Surrey, Dept Histopathol, RSCH, Guildford GU2 5XH, Surrey, England
[5] Birmingham Heartlands Hosp, Birmingham, England
[6] Univ Wales Hosp, Cardiff CF4 4XW, S Glam, Wales
来源：
AMERICAN JOURNAL OF CLINICAL PATHOLOGY | 2011年 / 135卷 / 01期
关键词：
HER2; Amplification; Breast neoplasms; Chromogenic in situ hybridization; CISH; Fluorescence in situ hybridization; FISH; Consistency; Intraobserver; Intersite; NEQAS; BREAST-CANCER; RECOMMENDATIONS; CARCINOMA;
D O I：
10.1309/AJCPVPRKK1ENEDGQ
中图分类号：
R36 [病理学];
学科分类号：
100104 ;
摘要：
We performed a multicenter assessment of a new HER2 dual-color chromogenic in situ hybridization (CISH) test and herein report on concordance of CISH data with fluorescence in situ hybridization (FISH) data and intraobserver and interlaboratory scoring consistency. HER2 results were evaluated using duplicate cores from 30 breast cancers in 5 laboratories using the Ventana HER2 dual-color ISH assay (Ventana Medical Systems, Cambridgeshire, England) and in I central laboratory using a standard FISH assay. Overall 93.3% of cases were successfully analyzed by CISH across the 5 participating laboratories. There was excellent concordance (98.0% overall) for diagnosis of HER2 amplification by CISH compared with FISH Intraobserver variability (7.7%) and intersite variability (9.1%) of absolute HER2/chromosome enumeration probe 17 ratios were tightly controlled across all participating laboratories. The Ventana HER2 dual-color ISH assay is robust and reproducible, shows good concordance with a standard FISH assay, and complies with requirements in national and international guidelines for performance of ISH-based diagnostic tests.
引用
收藏
页码：157 / 162
页数：6
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