title: Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH.
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 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.
authors.affiliation: Endocrine Cancer Group, Edinburgh University Cancer Research Centre, Western General Hospital, Edinburgh EH4 2XR, England.
authors.forename: J M S
authors.initials: JM
authors.lastname: Bartlett
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Campbell
authors.forename: Merdol
authors.initials: M
authors.lastname: Ibrahim
authors.forename: Peter
authors.initials: P
authors.lastname: Wencyk
authors.forename: Ian
authors.initials: I
authors.lastname: Ellis
authors.forename: Elaine
authors.initials: E
authors.lastname: Kay
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Connolly
authors.forename: Anthony
authors.initials: A
authors.lastname: O'Grady
authors.forename: Silvana
authors.initials: S
authors.lastname: Di Palma
authors.forename: Jane
authors.initials: J
authors.lastname: Starczynski
authors.forename: John M
authors.initials: JM
authors.lastname: Morgan
authors.forename: Bharat
authors.initials: B
authors.lastname: Jasani
authors.forename: Keith
authors.initials: K
authors.lastname: Miller
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis; D002886:Chromosomes, Human, Pair 17; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D017403:In Situ Hybridization / Q000379:methods*; D017404:In Situ Hybridization, Fluorescence / Q000379:methods*; D015588:Observer Variation; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D015203:Reproducibility of Results; D012834:Silver
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D012834:Silver; C508053:ERBB2 protein, human