Immunohistochemistry Assays Validation and Tissue Control

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In histopathology, IHC assays are used as diagnostic, prognostic or predictive tests and directly affect everyday management of patients in the clinical setting. They could also become a potential quick and cost effective replacement for the DNA sequencing based methods. Therefore, it is of critical importance that the IHC test is validated as specific for its target and of sufficient sensitivity. Hence, the importance of control tissues and the implementation of non IHC verification methods. The understanding and application of appropriate positive and negative control tissues is one of the most important yet misunderstood aspect of IHC. In this presentation, we review the 3 levels of IHC tests validation, we emphasize the importance of control tissues, and discuss the non IHC methods available for the verification of antibodies prior to usage in IHC.   

**This is a free member educational resource and does not qualify for CEUs **

Sihem Khelifa, MD

Sihem Khelifa, MD

Pathologist

Ventana-Roche

I am Sihem Khelifa, born and raised on the Mediterranean coast where in 1985, I had earned my M.D. degree at Annaba Medical School of Algeria. I then enjoyed studying Dermatology in Paris. However, after 15 years of fulfilling practice in both France and Algeria, I decided to move to the United States to become a pathologist.

While practicing Breast Pathology at Yale University as an assistant professor, I developed great interests in targeted medicine and biomarkers such as HER2 and ER/PR which led my move to the CDx department at Ventana Medical systems.        I also acted as Foreign Medical Director of the Breast Clinic in Wenzhou University Hospital in China where I initiated the practice of multidisciplinary tumor boards.

After five years of development of multiple assays at Ventana, I joined GSK for a one year pharma experience as CDx pathologist supervising the development of multiple CTA as well as innovating scoring methods for immune cells markers. Currently, I m back with Ventana supporting the development of a computer-assisted image analysis for the quantification of PD-L1 in solid tumors. More recently, I am providing educational support to the AstraZeneca US Medical Affaire Team.

 

When I am not working, I enjoy traveling, listening to music, cooking, and walking in the multiple state parks of Indianapolis with my husband Alexander.

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Immunohistochemistry Assays Validation and Tissue Control
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Open to view video. This webinar will cover 1) Validation levels for Immunohistochemistry (IHC) tests [FDA approved assays & laboratory developed tests (LDTs)] 2) Importance of control tissue during the validation process. 3) Non IHC studies during IHC tests validation. **This is a free member educational resource and does not qualify for CEUs **
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