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Søren Nielsen

Central Parameters in Optimization and Standardization of Applied Immunohistochemistry:
Controls and Critical Stain Quality Indicators


Immunohistochemistry (IHC) is a well established technique and used on a daily basis in virtually all departments of surgical pathology as a diagnostic, predictive and prognostic tool. IHC is an assay influenced by multiple parameters and the final immunohistochemical staining result will be highly dependent on the choice and performance of these variables. The multiple parameters influencing the results of IHC can largely be ascribed to 1) Pre-analytic parameters (i.e. tissue material, tissue handling before submission to the laboratory, tissue processing in the laboratory etc); 2) Analytic parameters (i.e. antigen retrieval procedure, primary antibody, visualization system, etc); and 3) Post-analytic parameters (i.e. results interpretation and reporting etc).
In order to evaluate that appropriate choices for all parameters have been selected and to secure that the final immunohistochemical result has the expected sensitivity and specificity it is crucial that appropriate controls are performed.
The presentation will give a review about the definitions and the use of positive and negative controls within IHC. A general introduction and practical examples how to design control blocks and how to interpret these will be given. The focus will be on the use of controls to evaluate the impact on both the pre-analytical and analytical parameters for the antibody of choice and how to use controls for the evaluation of the consistency and reproducibility of the immunohistochemical assays.


Søren Nielsen is senior histotechnologist and project coordinator at Institute of Pathology, Aalborg Hospital, Denmark. At the department, he has worked within immunohistochemistry for more than 20 years. He is scheme manager of Nordic immunohistochemical Quality Control (NordiQC) initiated in 1998 and established as a professional organization in 2003. He functions as assessor in the NordiQC general module, breast module and HER-2 ISH module. He is a regular lecturer and organizer of national and international immunohistochemical workshops, particularly in the field of protocol optimization. He is co-author of more than 20 scientific papers based on immunohistochemical studies.


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