Chromogenic In Situ Hybridization A Multicenter Study Comparing Silver In Situ Hybridization With FISH

被引：31

作者：

Bartlett, J. M. S. ^{[1
,2
]}

Campbell, Fiona M.

Ibrahim, Merdol ^{[2
]}

Wencyk, Peter ^{[3
]}

Ellis, Ian ^{[3
]}

Kay, Elaine ^{[4
]}

Connolly, Yvonne ^{[5
]}

O'Grady, Anthony ^{[4
]}

Di Palma, Silvana ^{[6
]}

Starczynski, Jane ^{[7
]}

Morgan, John M. ^{[8
]}

Jasani, Bharat ^{[9
]}

Miller, Keith ^{[2
]}

机构：

[1] Univ Edinburgh, Canc Res Ctr, Western Gen Hosp, Endocrine Canc Grp, Edinburgh EH4 2XR, Midlothian, Scotland

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

[3] City Hosp Nottingham, Dept Histopathol, Nottingham, England

[4] Beaumont Hosp, Dept Histopathol, Dublin 9, Ireland

[5] Adelaide & Meath Hosp, Dublin, Ireland

[6] Univ Surrey, Dept Histopathol, RSCH, Guildford GU2 5XH, Surrey, England

[7] Birmingham Heartlands Hosp, Birmingham B9 5ST, W Midlands, England

[8] Cardiff Univ, Cardiff & Vale NHS Trust, Dept Histopathol, Cardiff, S Glam, Wales

[9] Cardiff Univ, Sch Med, Dept Pathol, Cardiff, S Glam, Wales

来源：

AMERICAN JOURNAL OF CLINICAL PATHOLOGY | 2009年 / 132卷 / 04期

关键词：

HER2; Amplification; Breast; Chromogenic in situ hybridization; Silver in situ hybridization; Fluorescence in situ hybridization; Consistency; Intraobserver; Intersite; UK National External Quality Assessment Scheme; BREAST-CANCER; HER2; UK; RECOMMENDATIONS; CARCINOMA;

D O I：

10.1309/AJCPXY3MJ6GSRCYP

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

Our purposes were to perform a robust assessment of a new HER2 chromogenic in situ hybridization test and report on concordance of silver in situ (SISH) data with fluorescence in situ hybridization (FISH) data and on intraobserver and interlaboratory scoring consistency. HER2 results were scored from 45 breast cancers in 7 laboratories using the Ventana (Tucson, AZ) INFORM HER-2 SISH assay and in 1 central laboratory using a standard FISH assay. Overall, 94.8% of cases were successfully analyzed by SISH across the 6 participating laboratories that reported data. Concordance for diagnosis of HER2 amplification by SISH compared with FISH was high (96.0% overall). Intraobserver variability (8.0%) and intersite variability (12.66%) of absolute HER2/chromosome 17 ratios appear to be tightly controlled across all 6 participating laboratories. The Ventana INFORM HER-2 SISH assay is robust and reproducible, shows good concordance with a standard FISH assay, and complies with requirements in national guidelines for performance of diagnostic tests.

引用

页码：514 / 520

页数：7

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