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

J. M. S. Bartlett, Fiona M. Campbell, Merdol Ibrahim, Peter Wencyk, Ian Ellis, Elaine Kay, Yvonne Connolly, Anthony O'Grady, Silvana Di Palma, Jane Starczynski, John M. Morgan, Bharat Jasani, Keith Miller

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)514-520
Number of pages7
JournalAmerican journal of clinical pathology
Volume132
Issue number4
DOIs
Publication statusPublished - Oct 2009

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