PMID- 21173138
OWN - NLM
STAT- MEDLINE
DCOM- 20110120
LR  - 20191210
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 135
IP  - 1
DP  - 2011 Jan
TI  - A UK NEQAS ISH multicenter ring study using the Ventana HER2 dual-color ISH 
      assay.
PG  - 157-62
LID - 10.1309/AJCPVPRKK1ENEDGQ [doi]
AB  - 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 1 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.
FAU - Bartlett, J M S
AU  - Bartlett JM
AD  - Endocrine Cancer Group, Edinburgh, Scotland.
FAU - Campbell, Fiona M
AU  - Campbell FM
FAU - Ibrahim, Merdol
AU  - Ibrahim M
FAU - O'Grady, Anthony
AU  - O'Grady A
FAU - Kay, Elaine
AU  - Kay E
FAU - Faulkes, Catherine
AU  - Faulkes C
FAU - Collins, Nadine
AU  - Collins N
FAU - Starczynski, Jane
AU  - Starczynski J
FAU - Morgan, John M
AU  - Morgan JM
FAU - Jasani, Bharat
AU  - Jasani B
FAU - Miller, Keith
AU  - Miller K
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adenocarcinoma/*genetics/metabolism
MH  - Breast Neoplasms/*genetics/metabolism
MH  - Chromosomes, Human, Pair 17
MH  - Female
MH  - Gene Expression Profiling
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Pathology, Clinical
MH  - Receptor, ErbB-2/*genetics/metabolism
MH  - Tissue Array Analysis
MH  - United Kingdom
EDAT- 2010/12/22 06:00
MHDA- 2011/01/21 06:00
CRDT- 2010/12/22 06:00
PHST- 2010/12/22 06:00 [entrez]
PHST- 2010/12/22 06:00 [pubmed]
PHST- 2011/01/21 06:00 [medline]
AID - 135/1/157 [pii]
AID - 10.1309/AJCPVPRKK1ENEDGQ [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2011 Jan;135(1):157-62. doi: 10.1309/AJCPVPRKK1ENEDGQ.