Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH.
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.
Bartlett
J M S
JM
Endocrine Cancer Group, Edinburgh University Cancer Research Centre, Western General Hospital, Edinburgh EH4 2XR, England.
Campbell
Fiona M
FM
Ibrahim
Merdol
M
Wencyk
Peter
P
Ellis
Ian
I
Kay
Elaine
E
Connolly
Yvonne
Y
O'Grady
Anthony
A
Di Palma
Silvana
S
Starczynski
Jane
J
Morgan
John M
JM
Jasani
Bharat
B
Miller
Keith
K
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
D018719:Erb-b2 Receptor Tyrosine Kinases; D012834:Silver; C508053:ERBB2 protein, human