PMID- 19762528 OWN - NLM STAT- MEDLINE DCOM- 20091001 LR - 20151119 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 132 IP - 4 DP - 2009 Oct TI - Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH. PG - 514-20 LID - 10.1309/AJCPXY3MJ6GSRCYP [doi] AB - 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 hybridization (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. FAU - Bartlett, J M S AU - Bartlett JM AD - Endocrine Cancer Group, Edinburgh University Cancer Research Centre, Western General Hospital, Edinburgh EH4 2XR, England. FAU - Campbell, Fiona M AU - Campbell FM FAU - Ibrahim, Merdol AU - Ibrahim M FAU - Wencyk, Peter AU - Wencyk P FAU - Ellis, Ian AU - Ellis I FAU - Kay, Elaine AU - Kay E FAU - Connolly, Yvonne AU - Connolly Y FAU - O'Grady, Anthony AU - O'Grady A FAU - Di Palma, Silvana AU - Di Palma S 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 - Comparative 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 - 3M4G523W1G (Silver) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Breast Neoplasms/diagnosis MH - Chromosomes, Human, Pair 17 MH - Female MH - *Genes, erbB-2 MH - Humans MH - In Situ Hybridization/*methods MH - In Situ Hybridization, Fluorescence/*methods MH - Observer Variation MH - Receptor, ErbB-2/analysis MH - Reproducibility of Results MH - Silver EDAT- 2009/09/19 06:00 MHDA- 2009/10/02 06:00 CRDT- 2009/09/19 06:00 PHST- 2009/09/19 06:00 [entrez] PHST- 2009/09/19 06:00 [pubmed] PHST- 2009/10/02 06:00 [medline] AID - 132/4/514 [pii] AID - 10.1309/AJCPXY3MJ6GSRCYP [doi] PST - ppublish SO - Am J Clin Pathol. 2009 Oct;132(4):514-20. doi: 10.1309/AJCPXY3MJ6GSRCYP.