A UK NEQAS ISH multicenter ring study using the Ventana HER2 dual-color ISH assay

Bartlett, J. M. S., Campbell, F. M., Ibrahim, M., O'Grady, A., Kay, E., Faulkes, C., Collins, N., Starczynski, J., Morgan, John M., Jasani, Bharat and Miller, K. 2010. A UK NEQAS ISH multicenter ring study using the Ventana HER2 dual-color ISH assay. American Journal of Clinical Pathology 135 (1) , pp. 157-162. 10.1309/AJCPVPRKK1ENEDGQ

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Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	Q Science > QH Natural history > QH426 Genetics R Medicine > R Medicine (General) R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords:	HER2; Amplification; Breast neoplasms; Chromogenic in situ hybridization; CISH; Fluorescence in situ hybridization; FISH; Consistency; Intraobserver; Intersite; NEQAS
Publisher:	Lippincott, Williams & Wilkins
ISSN:	0002-9173
Last Modified:	18 Mar 2023 02:06
URI:	https://orca.cardiff.ac.uk/id/eprint/28620

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