ER/PR pharmDx™ Interpretation Manual - Dako
ER/PR pharmDx™ Interpretation Manual - Dako
ER/PR pharmDx™ Interpretation Manual - Dako
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Table of Contents<br />
Introduction 2<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx overview 3<br />
the <strong>ER</strong>/<strong>PR</strong> pharmDx Kit 4<br />
<strong>ER</strong>/<strong>PR</strong> Expression Rates 5<br />
Concordance studies 6<br />
n Concordance of Immunohistochemistry<br />
(IHC) to ligand-binding Assay<br />
n <strong>ER</strong>/<strong>PR</strong> pharmDx tM Concordance to the<br />
Allred Procedure<br />
n Determination of the Cut-off IHC score<br />
<strong>ER</strong>/<strong>PR</strong> Expression in normal tissue 9<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx training Checklist 10<br />
Quality Control 11<br />
Control slides for <strong>ER</strong>/<strong>PR</strong> pharmDx <br />
Validation 12<br />
Examples of Acceptable and<br />
Unacceptable staining of<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx Control slides 13<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx Results:<br />
Evaluation and Reporting 14<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx scoring system 15<br />
Image Guide for Allred scoring<br />
for <strong>ER</strong>/<strong>PR</strong> pharmDx 16<br />
n Estrogen Receptor<br />
n Progesterone Receptor<br />
Additional Images 18<br />
n Estrogen Receptor<br />
n Progesterone Receptor<br />
Additional specimens stained<br />
with <strong>ER</strong>/<strong>PR</strong> pharmDx 20<br />
Artifacts and Various Factors<br />
Affecting staining 21<br />
n Epitope Retrieval Artifacts<br />
n background staining<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx <br />
Pathology Report Form 22<br />
References 23<br />
<strong>ER</strong>/<strong>PR</strong> pharmDx <strong>Interpretation</strong> <strong>Manual</strong><br />
tAblE oF ContEnts<br />
1
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