Comparative performance of breast cancer human epidermal growth factor receptor 2 fluorescence in situ hybridization and brightfield in situ hybridization on college of American pathologists proficiency tests

Katherine B. Geiersbach, Julia A. Bridge, Michelle Dolan, Lawrence J Jennings, Diane L. Persons, Rhona J. Souers, Karen D. Tsuchiya, Patricia H. Vasalos, Joel T. Moncur*

*Corresponding author for this work

Research output: Contribution to journalArticle

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Abstract

Context. - Fluorescence in situ hybridization (FISH) and brightfield in situ hybridization (ISH) are 2 clinically approved laboratory methods for detecting ERBB2 (HER2) amplification in breast cancer. Objective. - To compare the performance of FISH and brightfield ISH on proficiency testing administered by the College of American Pathologists Laboratory Accreditation Program. Design. - Retrospective review was performed on 70 tissue core samples in 7 separate proficiency testing surveys conducted between 2009 and 2013. Results. - The samples included 13 consensus-amplified tissue cores, 53 consensus-nonamplified cores, and 4 cores that did not reach consensus for FISH and/or brightfield ISH. There were 2552 individual responses for FISH and 1871 individual responses for brightfield ISH. Consensus response rates were comparable for FISH (2474 of 2524; 98.0%) and brightfield ISH (2135 of 2189; 97.5%). The FISH analysis yielded an average HER2 copy number per cell that was significantly higher (by 2.86; P=.02) compared with brightfield ISH for amplified cores. For nonamplified cores, FISH yielded slightly, but not significantly, higher (by 0.17; P = .10) HER2 copy numbers per cell. There was no significant difference in the average HER2 to control ratio for either consensusamplified or consensus-nonamplified cores. Participants reported "unable to analyze" more frequently for brightfield ISH (244 of 2453; 9.9%) than they did for FISH (160 of 2684; 6.0%). Conclusions. - Our study indicates a high concordance rate in proficiency testing surveys, with some significant differences noted in the technical performance of these assays. In borderline cases, updated American Society of Clinical Oncology/College of American Pathologists cutoff thresholds that place greater emphasis on HER2 copy number per cell could accentuate those differences between FISH and brightfield ISH.

Original languageEnglish (US)
Pages (from-to)1254-1259
Number of pages6
JournalArchives of Pathology and Laboratory Medicine
Volume142
Issue number10
DOIs
StatePublished - Oct 1 2018

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Fluorescence In Situ Hybridization
In Situ Hybridization
Breast Neoplasms
Cell Count
human ERBB2 protein
Pathologists
Accreditation

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Geiersbach, Katherine B. ; Bridge, Julia A. ; Dolan, Michelle ; Jennings, Lawrence J ; Persons, Diane L. ; Souers, Rhona J. ; Tsuchiya, Karen D. ; Vasalos, Patricia H. ; Moncur, Joel T. / Comparative performance of breast cancer human epidermal growth factor receptor 2 fluorescence in situ hybridization and brightfield in situ hybridization on college of American pathologists proficiency tests. In: Archives of Pathology and Laboratory Medicine. 2018 ; Vol. 142, No. 10. pp. 1254-1259.
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abstract = "Context. - Fluorescence in situ hybridization (FISH) and brightfield in situ hybridization (ISH) are 2 clinically approved laboratory methods for detecting ERBB2 (HER2) amplification in breast cancer. Objective. - To compare the performance of FISH and brightfield ISH on proficiency testing administered by the College of American Pathologists Laboratory Accreditation Program. Design. - Retrospective review was performed on 70 tissue core samples in 7 separate proficiency testing surveys conducted between 2009 and 2013. Results. - The samples included 13 consensus-amplified tissue cores, 53 consensus-nonamplified cores, and 4 cores that did not reach consensus for FISH and/or brightfield ISH. There were 2552 individual responses for FISH and 1871 individual responses for brightfield ISH. Consensus response rates were comparable for FISH (2474 of 2524; 98.0{\%}) and brightfield ISH (2135 of 2189; 97.5{\%}). The FISH analysis yielded an average HER2 copy number per cell that was significantly higher (by 2.86; P=.02) compared with brightfield ISH for amplified cores. For nonamplified cores, FISH yielded slightly, but not significantly, higher (by 0.17; P = .10) HER2 copy numbers per cell. There was no significant difference in the average HER2 to control ratio for either consensusamplified or consensus-nonamplified cores. Participants reported {"}unable to analyze{"} more frequently for brightfield ISH (244 of 2453; 9.9{\%}) than they did for FISH (160 of 2684; 6.0{\%}). Conclusions. - Our study indicates a high concordance rate in proficiency testing surveys, with some significant differences noted in the technical performance of these assays. In borderline cases, updated American Society of Clinical Oncology/College of American Pathologists cutoff thresholds that place greater emphasis on HER2 copy number per cell could accentuate those differences between FISH and brightfield ISH.",
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Comparative performance of breast cancer human epidermal growth factor receptor 2 fluorescence in situ hybridization and brightfield in situ hybridization on college of American pathologists proficiency tests. / Geiersbach, Katherine B.; Bridge, Julia A.; Dolan, Michelle; Jennings, Lawrence J; Persons, Diane L.; Souers, Rhona J.; Tsuchiya, Karen D.; Vasalos, Patricia H.; Moncur, Joel T.

In: Archives of Pathology and Laboratory Medicine, Vol. 142, No. 10, 01.10.2018, p. 1254-1259.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparative performance of breast cancer human epidermal growth factor receptor 2 fluorescence in situ hybridization and brightfield in situ hybridization on college of American pathologists proficiency tests

AU - Geiersbach, Katherine B.

AU - Bridge, Julia A.

AU - Dolan, Michelle

AU - Jennings, Lawrence J

AU - Persons, Diane L.

AU - Souers, Rhona J.

AU - Tsuchiya, Karen D.

AU - Vasalos, Patricia H.

AU - Moncur, Joel T.

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N2 - Context. - Fluorescence in situ hybridization (FISH) and brightfield in situ hybridization (ISH) are 2 clinically approved laboratory methods for detecting ERBB2 (HER2) amplification in breast cancer. Objective. - To compare the performance of FISH and brightfield ISH on proficiency testing administered by the College of American Pathologists Laboratory Accreditation Program. Design. - Retrospective review was performed on 70 tissue core samples in 7 separate proficiency testing surveys conducted between 2009 and 2013. Results. - The samples included 13 consensus-amplified tissue cores, 53 consensus-nonamplified cores, and 4 cores that did not reach consensus for FISH and/or brightfield ISH. There were 2552 individual responses for FISH and 1871 individual responses for brightfield ISH. Consensus response rates were comparable for FISH (2474 of 2524; 98.0%) and brightfield ISH (2135 of 2189; 97.5%). The FISH analysis yielded an average HER2 copy number per cell that was significantly higher (by 2.86; P=.02) compared with brightfield ISH for amplified cores. For nonamplified cores, FISH yielded slightly, but not significantly, higher (by 0.17; P = .10) HER2 copy numbers per cell. There was no significant difference in the average HER2 to control ratio for either consensusamplified or consensus-nonamplified cores. Participants reported "unable to analyze" more frequently for brightfield ISH (244 of 2453; 9.9%) than they did for FISH (160 of 2684; 6.0%). Conclusions. - Our study indicates a high concordance rate in proficiency testing surveys, with some significant differences noted in the technical performance of these assays. In borderline cases, updated American Society of Clinical Oncology/College of American Pathologists cutoff thresholds that place greater emphasis on HER2 copy number per cell could accentuate those differences between FISH and brightfield ISH.

AB - Context. - Fluorescence in situ hybridization (FISH) and brightfield in situ hybridization (ISH) are 2 clinically approved laboratory methods for detecting ERBB2 (HER2) amplification in breast cancer. Objective. - To compare the performance of FISH and brightfield ISH on proficiency testing administered by the College of American Pathologists Laboratory Accreditation Program. Design. - Retrospective review was performed on 70 tissue core samples in 7 separate proficiency testing surveys conducted between 2009 and 2013. Results. - The samples included 13 consensus-amplified tissue cores, 53 consensus-nonamplified cores, and 4 cores that did not reach consensus for FISH and/or brightfield ISH. There were 2552 individual responses for FISH and 1871 individual responses for brightfield ISH. Consensus response rates were comparable for FISH (2474 of 2524; 98.0%) and brightfield ISH (2135 of 2189; 97.5%). The FISH analysis yielded an average HER2 copy number per cell that was significantly higher (by 2.86; P=.02) compared with brightfield ISH for amplified cores. For nonamplified cores, FISH yielded slightly, but not significantly, higher (by 0.17; P = .10) HER2 copy numbers per cell. There was no significant difference in the average HER2 to control ratio for either consensusamplified or consensus-nonamplified cores. Participants reported "unable to analyze" more frequently for brightfield ISH (244 of 2453; 9.9%) than they did for FISH (160 of 2684; 6.0%). Conclusions. - Our study indicates a high concordance rate in proficiency testing surveys, with some significant differences noted in the technical performance of these assays. In borderline cases, updated American Society of Clinical Oncology/College of American Pathologists cutoff thresholds that place greater emphasis on HER2 copy number per cell could accentuate those differences between FISH and brightfield ISH.

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