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Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH

Bartlett, J. M. S., Campbell, F. M., Ibrahim, M., Wencyk, P., Ellis, I., Kay, E., Connolly, Y., O'Grady, A., Di Palma, S., Starczynski, J., Morgan, John M., Jasani, Bharat and Miller, K. 2009. Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH. American Journal of Clinical Pathology 132 (4) , pp. 514-520. 10.1309/AJCPXY3MJ6GSRCYP

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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

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords: HER2; Amplification; Breast; Chromogenic in situ hybridization; Silver in situ hybridization; Fluorescence in situ hybridization; Consistency; Intraobserver; Intersite; UK National External Quality Assessment Scheme
Publisher: Lippincott, Williams & Wilkins
ISSN: 0002-9173
Last Modified: 19 Mar 2016 22:49

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