Chromogenic in situ hybridization

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

doi:10.1309/AJCPXY3MJ6GSRCYP

Chromogenic in situ hybridization

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

37 Citations (Scopus)

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.

Original language	English
Pages (from-to)	514-520
Number of pages	7
Journal	American Journal of Clinical Pathology
Volume	132
Issue number	4
DOIs	https://doi.org/10.1309/AJCPXY3MJ6GSRCYP
Publication status	Published - Oct 2009

Keywords

Amplification
Breast
Chromogenic in situ hybridization
Consistency
Fluorescence in situ hybridization
HER2
Intersite
Intraobserver
Silver in situ hybridization
UK National External Quality Assessment Scheme

ASJC Scopus subject areas

Pathology and Forensic Medicine

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

In: American Journal of Clinical Pathology, Vol. 132, No. 4, 10.2009, p. 514-520.

Research output: Contribution to journal › Article › peer-review

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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.",

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note = "Funding Information: Supported by The Finnish Academy of Sciences, The Finnish Cancer Society, The Sigrid Jus{\'e}lius Foundation, Maud Kuistila Foundation, Finnish Cultural Foundation, the Tampere University Hospital Research Foundation, and “les Amis de l'Institut Bordet” Brussels, Belgium. ",

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AU - Connolly, Yvonne

AU - O'Grady, Anthony

AU - Di Palma, Silvana

AU - Starczynski, Jane

AU - Morgan, John M.

AU - Jasani, Bharat

AU - Miller, Keith

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PY - 2009/10

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N2 - 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.

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.

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KW - Chromogenic in situ hybridization

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Chromogenic in situ hybridization

Abstract

Keywords

ASJC Scopus subject areas

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