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Søren Nielsen

International standardization of controls – the practical approach

Handout (pdf 46 p)

Handout (pdf 12 p)


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 parameters. 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. Simultaneously controls can be used to monitor the impact of modifications of each of the IHC variables in the total test approach.

However, in order to reliably evaluate the performance, consistency and impact of any modification of the IHC assay it is mandatory that both the choice and interpretation of control material are meticulously performed. The identification and use of best practice controls is perhaps the most central element for standardisation of IHC, as focus primarily must be on the reproducibility of IHC to ensure that the same results are generated inter- and intra-laboratorywise, whereas it is of less importance if same methods are used.

The presentation will give a review about the practical approach how to use positive and negative controls within IHC. Focus will be on controls for both the technical calibration and analytical validation of IHC. The guidelines for controls provided by the international ad-hoc groups will be discussed and perspectived.

EQA of breast marker analyses


The NordiQC breast cancer module comprises tests for some of the most important predictive and prognostic immunohistochemical (IHC) and in-situ hybridization (ISH) biomarkers as estrogen receptor (ER), progesterone receptor (PR) and HER-2. These biomarkers have profoundly been evaluated in NordiQC since 2003. For ER and PR significant improvements of the pass rates have been observed. Identification of appropriate positive and negative controls, best practice antibodies including Ready-To-Use systems and recommendable protocol settings have been central elements for the improvement.  Similarly, the pass rate for HER-2 IHC has been improved whereas the pass rate for HER-2 ISH has shown to be constant at a moderate level.
The overall assessment results in the NordiQC breast module will be summarized and briefly discussed during the presentation.


Søren Nielsen is senior biomedical scientist and project coordinator at Institute of Pathology, Aalborg Hospital, Denmark where 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 author and co-author of more than 25 scientific papers based on immunohistochemical studies and is member of the editorial board of international journals.

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