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Implementation of a Canadian External Quality Assurance Program for Breast Cancer Biomarkers

2009; Lippincott Williams & Wilkins; Volume: 17; Issue: 5 Linguagem: Inglês

10.1097/pai.0b013e31819adacf

1541-2016

Jefferson Terry, Emina Torlakovic, J. R. Garratt, Denise Miller, Martin Köbel, Jesse Cooper, Shakir Bahzad, Dragana Pilavdzic, Frances P. O’Malley, Anne E. O'Brien, Sandip Sengupta, Edward Alport, Bernard Têtu, Bryan Knight, Norman M. Pettigrew, Richard Berendt, Robert Wolber, Martin J. Trotter, Robert H. Riddell, Louis Gaboury, Ford Elms, Anthony M. Magliocco, Penny J. Barnes, Allen M. Gown, C. Blake Gilks,

Statistical Methods in Clinical Trials

Immunohistochemistry results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 are used to guide breast carcinoma patient management and it is essential to monitor these tests in external quality assurance (EQA) programs. Canadian Immunohistochemistry Quality Control is a web-based program with novel approach to EQA. Canadian Immunohistochemistry Quality Control RUN2 included tissue microarray slides with 38 samples tested by 18 immunohistochemical laboratories. Deidentified results were posted for viewing at www.ciqc.ca including all used protocols matched with scanned slides for virtual microscopy and garrattograms. Sensitivity, specificity, Kendall W test (concordance between laboratories), and kappa statistics (agreement with designated reference values) were calculated. Kappa values were within the target range (>0.8, or "near perfect" agreement) for 85% results. Kendall coefficient was 0.942 for estrogen receptor, 0.930 for progesterone receptor, and 0.958 for human epidermal growth factor receptor 2. The anonymous participation, quick feedback, and unrestricted full access in EQA results provides rapid insight into technical or interpretive deficiencies, allowing appropriate corrective action to be taken whereas the use of tissue microarrays enables meaningful statistical analysis.