1st NordiQC Conference on Standardization in Applied Immunohistochemistry

Transcription

1 Hotel Hvide Hus, Aalborg, 4 th 7 th June 2013 Prof. Mogens Vyberg, NordiQC director Serial sections stained for Estrogen receptor Breast cancers stained for Estrogen receptor Why?

2 Breast cancers stained for CK-HMW Breast cancers stained for CK-HMW CK5 34BE12 HIER+PROT Lab. C Lab. C 34BE12 HIER IHC quality problem Immunohistochemistry Staining patterns and quality varies between different laboratories - depending on the expertise and individual selection of reagents and methods Different antibodies, visualization systems, chromogenes, platforms and guide lines give different results Internal quality control will often not identify a poorly calibrated IHC system or varying quality of products giving insufficient or aberrant staining results External quality assessment is mandatory 9 Processing decalcification Tissue type, dimensions, biological variation (tumour dediff.) cauterization Interpretation quantification pos./neg. def. -cut-off level panels algorithms Sections thickness drying storage Fixation delay, time, type, volume Pre-treatment proteolysis, HIER, time, temp, ph Platform manual stainer type Visualization system sensitivity, specificity enhancement Reporting diagnostic context Control internal/external critical stain quality indicators Primary antibody clone, dilution buffer, time, temp Analytic Chromogene sensitivity, Immunohistochemistry External Quality Assessment Processing decalcification Tissue type, dimensions, biological variation (tumour dediff.) cauterization Fixation delay, time, type, volume Interpretation quantification pos./neg. def. -cut-off level panels algorithms Preanalytic Postanalytic Pre- EQA analytic Sections thickness drying stainer storage Postanalytic Pre-treatment proteolysis, HIER, time, temp, ph Platform manual type Visualization system sensitivity, specificity enhancement Reporting diagnostic context Control internal/external critical stain quality indicators Primary antibody clone, dilution buffer, time, temp Analytic Chromogene sensitivity, Nordic immunohistochemical Quality Control Founded 2003 by Nordic pathologists Independent, scientific, not-for-profit organisation Institute of Pathology, Aalborg University Hospital General module: 3 runs/year different markers Breast cancer IHC module: 2 runs HER-2, ER/PR, Ki/E-Cad HER-2 ISH module: 2 runs/year BRISH, FISH

3 NordiQC participants NordiQC Assessments ~ 40 countries Central assessment with consensus between experienced pathologists and histotechnologists Nordic countries Correlate staining results with central protocol parameters in order to identify Successful and less successful Abs Appropriate and inappropriate protocol settings Staining platform issues Reliable control tissues Publish general results on an open website: General Breast ca. IHC HER-2 ISH individual results to the participants Specific explanations for insufficient results Tailored recommendations for improvement 14 NordiQC Assessments Assessments > 50 runs = > 30,000 slides = > 150,000 tissue sections = > 1,500,000 bits of protocol info. Results of NordiQC recommendations 419 advices for 11 markers No. Improved % Positive Negative NordiQC EQA: Estrogen Receptor HER-2 staining results in 10 runs % articipants No. pa B1 B3 B5 B7 B8 B10 B RUN PASS RATE (%) No. OF PARTICIPANTS

4 Economic impact of HER-2 test inaccuracy IHC External Quality Assessment Application of NordiQC test results in an economic model for the US population (unpublished) Approved IVD Nonapproved IVD Total Number of tests 1145 (%) 558 (33%) 1703 Pooled FN + FP rates 11% 30% Total costs $M 14 $M 55 $M 69 About 30% of all IHC stains assessed by NordiQC are still insufficient! New labs New antibodies, techniques, platforms Increasing demands How many IHC stains produced by labs not participating in an EQA scheme are insufficient? How many scientific publications are based on insufficient IHC stains? 19 Optimized Ki staining how to count? Ki staining in two labs - no sense in counting ROI - Hotspot or average? Cut off for staining intensity? Enjoy your stay in Aalborg Hormone receptors HER-2 Ki Gene profiling in relation to IHC Mutation specific protein markers Haematopathology markers EQA programmes Central parameters in optimization / standardization Image analysis and stereology in relation to IHC Handouts are available on the website

5 KUNSTEN Museum of Modern Art Dinner in Robber s Camp Thursday Bus dept. 18:00 Name badges must be worn at all times Tickets presented at bus departure Reception Wednesday 18:00 19:30 Name badges must be worn at all times Icelandic artist Olafur Eliasson 25 Hotel Hvide Hus, Aalborg, 4 th 7 th June 2013 Prof. Mogens Vyberg, NordiQC director Welcome to Aalborg