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//-->I N T E R P R E TAT I O NFLEX Ready-to-UseAtlas of Stains - 4thEditionA Better Path forCancer DiagnosticsCommitted to raising the bar for higher qualityDuring the last decades, organizations such as CAP, UK NEQAS and NordiQC have successfullyimplemented many initiatives to improve standardization in immunohistochemistry. At the sametime, laboratories are striving to deliver accurate clinical diagnostic results while facing and adapt-ing to the increasing number of challenges. It is vital for pathology laboratories to make continuousimprovements to maintain the quality of diagnoses, and to be a professional counterpart and keyresource to oncologists, and other clinicians.Pathology laboratories face an increasing number of challenges todaynEscalating workload due to higher number of immunohistochemistry tests per patient casenTime-consuming proceduresnLack of qualified staffnHealthcare costs- aging population with a corresponding rise in cancer cases- higher number of immunohistochemistry tests per patient casenLow reproducibility and quality issuesnInadequate workflow optimizationnMultiple steps of information transcription in various systemsWhile overcoming these challenges, a pathology laboratory must also improve time to diagnosisand reduce error rates, while delivering correct diagnostic results with a high level of certainty thatthe physician can rely on.At Dako, we are committed to supporting pathology laboratories to overcome these challengesWe strive to deliver scientific advancements through leading-edge products and services to facili-tate better, more informed decision making in diagnostics.Dako is the first company in the industry, to embed high-quality control concepts into ready-to-use procedures. The Dako FLEX Ready-to-Use (RTU) primary antibodies work on formalin-fixed,paraffin-embedded, tissue sections as a set of dedicated reagents for clinical routine diagnostics.The FLEX RTU concept is unique, since it focuses on delivering the correct diagnostic end-resultwhile improving time to diagnosis, reducing manual error rates, and simplifying information retrievalthrough bar-coded labeling. Equally important, it maintains and delivers reliable staining perfor-mance.The Dako FLEX RTU antibody selection, together with the easy-to-use Dako EnVision™ FLEX/FLEX+ visualization systems provide:nConsistently high diagnostic certaintynEfficient workflow with predictable speed and high capacitynService and support you can rely on for maximum uptimeThis guide is the product of collaboration with a panel of distinguished experts in the field of pa-thology. At Dako we work to build lasting partnerships with leading experts to ensure that we opti-mize the staining performance of our products in line with your demands.Our aim is that this guide will support you on a better path in cancer diagnostics.Dako. A Better Path.For further information on antibody panels and staining performance, we recommend the following references:- Dabbs D et. al., Diagnostic Immunohistochemistry, 3rd Edition, Elsevier, 2006- Taylor C. R. et. al. Immunomicroscopy, 3rd edition, vol. 19, 2007- Jasani B. and Schmid K.W, Immunocytochemistry in Diagnostic Histopathology, W.B. Saunders Company, 1993- The UK NEQAS home page for immunocytochemistry: http://www.ukneqasicc.ucl.ac.uk/- The NordiQC home page: http://www.nordiqc.org© Copyright 2012 Dako.All rights reserved. No part of this Atlas may be reproduced, copied or transmitted without written permission.Ensuring desired staining performance with the help of an expert panelThe FLEX RTU concept was launched in 2008, and the staining performance of the productswas developed in collaboration with leading pathologists and their laboratory managers. In theprocess of ensuring desired staining performance, a panel of these distinguished anatomicpathology experts specified the relevant criteria and reviewed the staining results obtained duringdevelopment of all the antibodies.During a year-long process, the expert panel specified the required staining performance for eachindividual antibody.In acknowledging the many contributions we have received, we wish to thank the members ofour expert panel and their laboratory managers for sharing their knowledge and insight:From left: Mr. Andrew Dodson, Royal Liverpool University Hospital, UK Prof. Dr. Alvin Martin University of Louisville School ofMedicine Department of Pathology, USA Mr. Søren Nielsen Aalborg Hospital , Department of Pathology, Denmark Prof. Dr.Robert Osamura, Tokai University School of Medicine, Japan Dr. Clive Taylor, Keck School of Medicine of USC, USA Ms.Sheron Lear University of Louisville School of Medicine Department of Pathology, USA Dr. David Dabbs, Magee Women’sHospital, USA Dr. Miguel Piris Centro Nacional de Investigaciones Oncologicas Carlos III, Spain Dr. Kengo Takeuchi,Japanese Foundation for Cancer Research, Japan Prof. Dr. Bharat Jasani, Cardiff University, UK Mrs. Lydia Sánchez VerdeCentro Nacional de Investigaciones Oncologicas Carlos III, Spain Dr. Assia Bassarova Radiumhospitalet, Oslo, Norway Dr.John Gosney Royal Liverpool University Hospital, UK Mrs. Kim Mcmanus Magee Women’s Hospital, USA Dr. Jahn NeslandRadiumhospitalet, Oslo, Norway (not in the photo)Based on these guidelines, Dako has developed a standard procedure for all FLEX Ready-to-Use(RTU) primary antibodies that increases productivity without compromising the staining perfor-mance accepted by the expert panel. Using the guidelines, this Atlas of Stains provides examplesof the staining performance which the panel accepted. The accompanying descriptions are sum-maries of the written input initially submitted by the expert panel for the guidelines.We also thank Cooperative Human Tissue Network (funded by the National Cancer Institute)for providing valuable human tissues for our studies.Dako will continuously launch new FLEX RTU antibodies, which are directly suited to the needs ofpathologist laboratory. The performance and staining of these products have been reviewed andaccepted by Dr. Clive Taylor, Keck School of Medicine of USC, USA, Biomedical Scientist SørenNielsen, Scheme Organizer at NordiQC, Denmark, and Associate Professor Mogens Vyberg,Aarhus University Hospital, Denmark. The new clones will be marked in Atlas of Stains with “NEW”.This Atlas of Stains is by no means intended to override the professional judgment of acertified pathologist. The contents are provided as information only, and Dako neitherclaims nor warrants the universal validity of the information provided concerningDifferential Diagnosis, as there are national and professional differences in the accept-ance of the relevance of various markers.FLEX Ready-to-UseDuring the past 40 years, immunohistochemistry has become increasingly important in diagnosticpathology, and is now an essential daily tool for cancer diagnosis in most laboratories worldwide.This has led to intense focus on utilizing and expanding IHC for purposes such as implementationof new markers, use of established markers in new areas, and optimization of immunohistochemi-cal techniques. However, IHC is technically complex, and determining what to choose in order todeliver the right results is a major challenge for laboratories. The fact is that there are more than 1million options when a pathologist sets up a protocol to analyze and report on merely one singleantibody!This is why it is so encouraging that Dako has developed the FLEX Ready-to-Use Immunohisto-chemical System. Dako’s reagents have been set up for use in optimized and streamlined proto-cols, as a robust backbone for a wide range of diagnostic markers.The system has been designed on the basis of input from IHC experts in surgical pathology whohave long and widely acknowledged experience in both general pathology and hematopathology.Input from this large number of IHC experts have been used to align the system and the antibod-ies to obtain the quality necessary for meeting the demands of routine diagnostic procedures. Toobtain appropriate sensitivity and specificity in developing the Ready-to-Use ImmunohistochemicalSystem, the performance of each primary antibody has been tested on a wide range of cancerswhich reflect the diagnostic applications of the specific antibody. Each primary antibody has alsobeen tested on various benign tissues to identify positive controls that could be recommended.Identification of benign tissue for recommended control and the precise description and photo-graphs of microscopic reaction patterns in the Atlas of Stains are truly unique, and will greatlyfacilitate final quality evaluation of the antibody markers in laboratories.By providing access to a photo gallery and library of detailed information on appropriate controlsin the use of antibodies – and how to interpret control and reaction patterns – the Atlas of Stainsis destined to become a valuable tool for all laboratories that perform IHC from local clinics andhospitals to large university laboratories.Always remember: There is no Ready-to-Use antibody! There is a Ready-to-UseImmunohistochemical System.To obtain the performance accepted by the surgical expertsand portrayed in the Atlas of Stains, the new series of FLEX Ready-to-Use antibodies must beused within the system frames established by Dako.Søren NielsenScheme Coordinator, NordiQCAalborg University Hospital, DenmarkHow to read the Atlas of StainsThe diagnostic staining performance delivered by the Dako FLEX Ready-to Use (RTU) system has been accepted byleading experts in the field and worked out in collaboration with Søren Nielsen, Scheme Organizer at NordiQC. TheDako FLEX RTU procedure makes it possible to deliver a high quality staining performance in all relevant clinical tissues.Information on the antibodies has been organized under the following four headings:ApplicationnReaction LocationnRecommended ControlnDifferential DiagnosisThe Atlas of Stains illustrates the staining performance of each antibody in the FLEX RTU system and providesexamples of:performance in relevant clinical tissues (See below examples in Figure 1A and 1B andFigure 2A and 2B)ntaining performance in the recommended control tissue (See below examples in Figure 1C and Figure 2C)STable 1. Quality indicatorsQuality indicatorHigh-expression (HE) structuresLow-expression (LE) structuresFigure 1.FLEX RTU Monoclonal Mouse Anti-HumanCD79a, Clone JCB117, Code IR621 or IS621.IHC staining intensityModerate to strongWeak to moderatentainingSnClinicalFigure 1A.Precursor B-lymphoblastic leukemia/lymphoma disseminatedto testis stained with Anti-CD79a. The majority of the neoplastic cells showa weak to moderate membraneous and cytoplasmic staining reaction.Figure 2.FLEX RTU Monoclonal Mouse Anti-HumanCalretinin, Clone DAK-Calret 1, Code IR627 or IS627.Figure 2A.Granulosa cell tumor stained with Anti-Calretinin. The majorityof the neoplastic cells show a weak to moderate nuclear and cytoplasmicstaining reaction. [ Pobierz całość w formacie PDF ]