Connection: The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) convened an expert panel to develop a guideline to improve the accuracy of HER2 testing in invasive breast cancer. The ASCO/CAP Guideline is also followed by Canadian pathologists with some modifications (Hanna W, et al. Curr Oncol. 2007 August; (4): - 149­153). Can you explain the guidelines followed in the United States for HER2 testing? HER2 testing requires a quantitative analysis be performed on breast tumors. Most immunohistochemistry stains are qualitative. Immunohistochemistry testing like HercepTestTM rely on the qualitative analysis and enumeration of the expression of HER2/neu protein positive cells to determine and guide clinical treatment for the patient. Therefore, it is imperative that an accurate qualitative number be properly assessed and similarly be universally attainable. Clinicians need to have confidence that the quantification will be unvarying from laboratory to laboratory. The development of standards for HER2/neu positive cells allows for pathologists to remove their bias and preference for chromogenic intensity by creating guidelines that are objective and universal. Connection: How about estrogen and progesterone receptor biomarker tests? I would like to see the same criteria applied to ER and PR. The objectification of chromogenic staining intensity provides for greater accuracy and reliability in the diagnosis and treatment of breast cancer. Connection: Antigen retrieval is essential in immunohistochemistry (IHC) in order to restore epitopes. There are a large number of devices, which can be used to achieve this aim (microwaves, rice steamers, pressure cookers, autoclaves and commercial de-cloaking devices). However, the variability of results achieved, not only from one device to another, but also between and within runs using the same device, can be vast (Gray DS, Selbie D, Cooper RF et al. , Simultaneous de-waxing and standardisation of antigen retrieval in Immunohistochemistry using commercially available equipment. Immunocytochemistry 2006; 13-17). What protocol do you follow for antigen retrieval? Do the protocols meet the standards required by UK NEQAS, NordiQC, United States College of American Pathologists (CAP)? Or do you have your own standards at MGH? At MGH we perform our antigen retrieval on the IHC instrument itself. Occasionally, we use the pressure cooker method using the citrate buffer in the Coplin jar and in the pressure chamber itself. This procedure meets the standards established by the College of American Pathologists and is monitored and documented for its consistency. Connection: How would you rate European (UK NEQAS, NdoriQC) IHC Standards? I am not familiar enough with the UK NEQAS and Nordi QC standards to appropriately rate them. confidence Clinicians need to havewill be unvarying that the quantification from laboratory to laboratory. Connection: Are Unites States IHC Standards followed anywhere else in the world? I am not aware of it. Connection: Can you comment on the internal and external quality control (EQC) procedures followed in the United States? Specifically, which agency in the Unites States is involved in EQC? CAP and The Joint Commission for the Accreditation of Hospital Organizations require that any analyte-specific reagents (ASR) are validated both internally and externally every year. We consider IHC antibodies to be ASRs. Our internal quality control is performed by validating the antibodies between instruments using identical reagents and protocols on the same patients tissue specimen. External quality control monitoring is often performed when consultations are requested from an outside institution where we will stain a slide with a specific antibody and send an identical slide to the consulting institution or pathologist. The consultation report is compared with the results of the IHC testing performed at MGH. We then evaluate the concordance of the two results and record the data. 29 | Connection 2008 April 2008, VOL 11 Connection IHC STANDARDIZATION AROUND THE WORLD In this issue Q&A with Patho Contents APRIL 2008, VOL 11 2 3 4 Editorial George L. Kumar, PhD Featured Laboratory The Osamura Editorial Immunohistochemistry (IHC) Standardization Around the World George L. Kumar, PhD Managing Featured Laboratory The Osamura Laboratory Laboratory headed by Prof. Robert Yoshiyuki Osamura, MD, Q&A Ask the Experts: On Immunohistochemistry (IHC) Standardization Professor Leong is Medical Di time interval between removal of tissue and immersion in fixative, the temperature of tissue storage Connection: How would you like to standardize IHC in Australia? As discussed above, standardization Connection: Antigen retrieval is essential in immunohistochemistry (IHC) in order to restore epitope Connection: Is a universal image analysis system feasible? No, not until we standardize the all impo Q&A Fernando Soares, MD, PhD University of São Paulo, São Paulo, Brazil Dr. Fernando Soares is F Connection: In your opinion, what is the biggest hurdle for standardization? Probably education in l There are no standards in Latin America. We always follow the manufacturers protocol during our firs Q&A Bryan R. Hewlett, ART, MLT Consultant Technologist to the Anatomic Pathology EQA program of There is no standardization of AR steps circumstances, it would be impossible toand, undera the pre Connection: How would you rate European (UK NEQAS, NordiQC) and US IHC standards to Canadian IHC sta Q&A Prof. Chen Jie Prof. Cui Quancai Peking Union Mediacl College Hospital, Beijing, China Prof. Connection: According to Goldstein et al. Appl Immunohistochem Mol Morphol 2007;15:124­133 Immunohis Connection: Is it true that a particular histology feature may be better demonstrated by other fixat Connection: What constitutes standardization of image analysis as applied to immunohistochemistry (I Q&A Dr. Tanuja Manjanath Shet Dr. Vani Parmar Tata Memorial Hospital, Mumbai, India Tanuja Manj ... the biggest hurdle in India is suboptimal fixation and processing of tissues. Though I agree th Connection: Is it true that a particular histology feature may be better demonstrated by other fixat Connection: Can you comment on the internal and external quality control (EQC) procedures followed i Q&A Prof. Robert Yoshiyuki Osamura Department of Pathology, Tokai University School of Medicine Connection: In your opinion, what is the biggest hurdle for standardization? The biggest hurdle for the standardization of image ... appropriate for pre-screeninganalysis is of the staining quality. Connection: Why is standardization of image analysis in diagnostic pathology important? Because the Q&A James F. Happel, DLM (ASCP), HTL Technical Director of Surgical Pathology, Research and Deve Connection: United Kingdom National External Quality Assessment Service (UK NEQAS) helps to ensure t Connection: The American Society of Clinical Oncology (ASCO) and the College of American Pathologist would recommend that standardization Ibegin with identifying a reliable and trustworthy source ... Interview Immunohistochemistry for Oestrogen and Progesterone Receptors Dr. Andrew Lee Consultant H Connection: What is the difference between the H score and the Allred score? Which is better? What d Connection: Can you comment on the burden in the laboratory, if one changes from a current ER/PR ass Opinion & Interview IHC Standardization: A Dako Perspective Dr. Ole Rasmussen R&D Director, Connection: Dako has developed Readyto-Use Antibodies for in vitro diagnostic applications. How is t Articles UK NEQAS-ICC & ISH: Historical perspective, current role, future directions Andy Dodso UK NEQAS-ICC in the 1990s In his first year as Scheme Organiser, Keith oversaw the transition to sub The application could be argued to represent a field change in terms of the rigour with which the an Assessment teams consist of four assessors, who view slides around a multi-headed microscope and sco The archive which UK NEQAS holds, both in terms of stained slides and methodological data, must sure For Immunocytochemistry and FISH RESULT: RUN 80L SLIDE: NEQAS Laboratory No: XXX Mr. A. Scientist De Figure 6. Feedback on results has always been given high priority, and for many years this has been a b c d Figure 7. The antigen chosen by Gerry Reynolds for his very first assessment run was kap Bibliography Selected UK NEQAS-ICC & ISH papers. Ibrahim M, Dodson AR, Barnett S, Fish D, Jasani Articles Nordic Immunohistochemical Quality Control (NordiQC) An Organization for External Quality A parameters (i.e. results interpretation and reporting) (4, 5). In an EQA setting, by circulating ser CD79a (Fig. 2) Among 112 laboratories submitting stains in the latest run, most used mAb clone JCB11 References 1. Rhodes A, Jasani B, Barnes DM, Bobrow LG, Miller KD. Reliability of immuno-histochemic Fig. 2. CD79a A. Optimal CD79a staining of the tonsil using the monoclonal antibody (mAb) clone JCB Standardization of Ki-67 Immunohistochemical Staining for Diagnosing Grade of Gastrointestinal Strom was conducted in 49 GIST cases. The concordance rate for the evaluation results at three laboratorie CB pH6 a b c d TE pH9 e f g h Autoclave 121° C/10 min Water bath 95° C/40 min Microwave 50 Table 1. Correlation between NCC and STD methods R2=0.9483 Categories of proportion NCC Method 3 Opinions Importance of Standardization for Predictive Prognosis David J. Dabbs, MD Chief of Pathol is documented and serves as a surrogate marker for the initial exposure to formalin. Since the first Opinions The New Era for ER and PRIts time to Standardize! Dr. Ian Ellis, B.Med.Sci. BM, MS, FRCpa et al 2001). The main reason for false-negative results is due to inefficient heat-induced epitope ( Standardization of HER2 TestingInconsistency Raises Questions Opinions Sunil S. Badve, MD, FRCPath rence seen in these trials is in the order of 50%. This is the major reason for all the excitement a which now requires expression of HER2 by at least 30% of tumor cells (instead of 10%). It has also r IHC CONSENSUS MEETING, JANUARY 27 2008, SANTA BARBARA, CA, USA , IHC CONSENSUS MEETING, JANUARY 27, Richard Cartun, PhD, Sunil Badve, MD Jon Askaa, PhD Søren Nielsen, HT, CT, Mogens Vyberg, MD Elizab Dako Abstracts Abstracts presented at the 30th Annual San Antonio Breast Cancer Symposium December Dako Abstracts Amplification of ESR1 may predict resistance to adjuvant tamoxifen in postmenopausal Dako Abstracts Abstracts presented at the United States and Canadian Academy of Pathology (USCAP) A Dako Abstracts Metastatic Pancreatic Endocrine Tumors in the Liver Express KOC Briones AJ, Bourne P Dako Abstracts Merkel Cell Carcinomas Express K Homology Domain Containing Protein Overexpressed in Dako Abstracts Immunohistochemical Analysis of KOC/IMP3 in Malignant Pleural Mesothelioma Xu H, Sim Dako Abstracts KOC, TTF-1 and CDX2 Discriminate Small-Cell Carcinoma from Carcinoid and Pancreatic Dako Publications Publications Co-authored by Dako: In Press Li L, Xu H, Spaulding B, Cheng L, Si Dako Meetings 2007 - National Society for Histotechnology Meeting. Denver, CO NSH workshop attend New Premium Quality Concentrated Antibodies New Products Your current and future needs drive the c Targeting Colorectal Adenocarcinomas, Anti-TIMP-1 and Anti-Villin Monoclonal Mouse Anti-Human Tissue Dakos FLEX Ready-to-Use Concept Enhance performance of your laboratory by running FLEX Ready-to-Use 2008 Product Catalog Available Now! The catalog features more than 170 new products, including the A