Connection: Can you comment on the internal and external quality control (EQC) procedures followed in India? Specifically, which agency in India is involved in EQC? Cf. 4 and 5. Connection: What are the major benefits of EQC? All labs work toward their best, but they really dont know where they stand ­ so EQA is the external stamp of approval ensuring good quality and the comparative exercise also helps us solve problems. Connection: Would a template/procedure/scoring system for reporting IHC standardization assays be beneficial? Do you recommend it? At our institute, where pathologists are highly individualistic, they do not prefer brackets or templates of any kind except when it is clinically relevant like e.g. breast cancer. As I mentioned earlier, often it is a positive and a negative result in IHC and templates/scoring will help only where quantification is required. These templates have advantages of ensuring uniformity and may be used, if one wishes to. The major problem with manual scoring systems is the reproducibility. Connection: What constitutes standardization of image analysis as applied to immunohistochemistry (IHC)? Can we have a standardized procedure to interpret IHC assays around the world? As of now, a major concern of clinicians using targeted therapies in cancer is the variability in the IHC reporting. Image analysis will help us quantify IHC better with reproducibility and universally maintained standards. These systems yield a graphical and numerical value report. These image analyzers come in wide ranges and at different prices and require training before use. Operator expertise will be an issue in standardizing these methods thence. I think, in a world that is already divided into a developed and a developing world, economic issues in IHC will be a hurdle to standardized image-assisted IHC usage. I do not have experience in the use of image analysis to routine diagnostic labs. However, image analysis should manage to allow for an objective evaluation of stains. It also allows sending images for opinion and standardization. Connection: Why is standardization of image analysis in diagnostic pathology important? Though I dont have experience with image analysis in diagnostic pathology, I suspect it is prone to operator errors and variation based on basic infrastructure quality. Tumors have different sizes and shapes, so defining an area to be counted is difficult. Connection: What are your recommendations for standardizing image analysis in an anatomic pathology laboratory? A general purpose program may not be applicable to all labs, and newer modules will work on different systems, so each lab should define its need and use a friendly program. Intensive training for use of a system is required. Connection: Is a universal image analysis system feasible? The biggest disadvantage of image analysis is the cost. In India, computers are just standing erect and the infrastructure is expensive. We do have image analysis software in our lab ­ but the technology part keeps pathologists away from it. Connection: In your opinion, what is the biggest hurdle for standardization in image analysis? Lack of computer savvies - plus the cost and time consumed. Secondly, most image analyzers require well-stained slides, the right color without folds, etc., which is a problem. Connection: With image analysis in mind, what is the minimum informational need to enable the interpretation of IHC results? I think teaching the way a system works is a bare minimum for using it. Also, the criteria for interpreting a stain ­ such as the location of stain and scoring system for use as positive - is required. Connection: Is there a lot of variability in manual IHC testing? How do image analysis systems improve the scoring of IHC slides? I agree with the variability in manual systems and that image analysis improves scoring, but as mentioned earlier every applicability has two sides. Connection: Where do you see IHC in 10 years? I see that IHC is going to be omnipresent and cheaper, just as the good old H&E is in all labs today. Connection: As a leader in the industry, how have you kept up with the changes occurring in IHC/pathology? The workload, an active clinical unit, and plethora of interesting cases or newer entities in pathology journals keeps us on the toes for newer, diagnostic antibodies. We also take help of some Web sites to solve our queries. Connection 2008 | 22 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