Atlas of Controls - 1st Edition

FLEX Ready-to-Use
Atlas of Controls
First Edition
2
Comitted to raising the bar for
higher quality
For years, pathology laboratories around the world have had to face and adapt to an
increasing number of challenges, while continuing to strive to deliver accurate IHC results
for patients. One of the most important of these challenges is to make continuous
improvements to maintain the quality of staining, and to be a professional counterpart
and key resource to oncologists and other clinicians. To help with this, organizations such
as CAP, UK NEQAS, cIQc, and NordiQC have successfully implemented many initiatives to
improve standardization in immunohistochemistry (IHC).
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-result while improving time to diagnosis, reducing manual
error rates, and simplifying information retrieval through bar-coded labeling. Equally important, it maintains and
delivers reliable staining performance.
The FLEX RTU concept was launched in 2008, and the staining performance of the products was developed
in collaboration with leading pathologists and their laboratory managers. In the process of ensuring desired
staining performance, a panel of these distinguished anatomic pathology experts specified the relevant
criteria and reviewed the staining results obtained during development of all the antibodies. We wish to thank
the members of our expert panel and their laboratory managers for sharing their knowledge and insight: Mr.
Andrew Dodson, Royal Liverpool University Hospital, UK Prof. Dr. Alvin Martin, University of Louisville School
of Medicine 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’s Hospital, 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 Ms. Lydia Sánchez Verde Centro Nacional
de Investigaciones Oncologicas Carlos III, Spain Dr. Assia Bassarova, Radiumhospitalet, Norway Dr. John
Gosney, Royal Liverpool University Hospital, UK Ms. Kim McManus, Magee Women’s Hospital, USA Dr. Jahn
Nesland, Radiumhospitalet, Norway. We also would like to thank Cooperative Human Tissue Network (funded
by the National Cancer Institute) for providing valuable human tissues for our studies.
For this new Atlas of Controls, Søren Nielsen, in his current role as Director of NordiQC, Denmark, has reviewed
all stains and carefully selected representative area of stained sections containing relevant high and low
expression structures for quality control for each antibody.
This Atlas of Controls is by no means intended to override the information contained in the Instructions
for Use and the professional judgment of a certified pathologist. The contents and descriptions of staining
patterns are provided to add additional information and suggestions for quality control only, and Agilent
neither claims nor warrants the universal validity of the information provided, as there are national and
professional differences in the acceptance of the relevance of various markers and related quality control
tissues.
3
They key to successful IHC results
is control tissue
Despite great advances in genetic testing, especially in next generation sequencing,
immunohistochemistry is still the most important technique in diagnostic pathology and is an
essential daily tool for cancer classification in most laboratories worldwide. There is an ongoing
focus on utilizing and expanding IHC for purposes such as implementation of new markers, use
of established markers in new areas and optimization of immunohistochemical techniques.
Many laboratories are now participating in external quality assessment (EQA)

schemes which detect differences of IHC quality between laboratories and
provide guidance on how to achieve optimal and comparable results. Still,
there is a need for improvements and for communication in the field of IHC,
particularly due to the considerable variations in both standards and routines
among laboratories.
To obtain appropriate sensitivity and specificity in developing the FLEX

RTU system, the performance of each primary antibody has been tested
on a wide range of cancers which reflect the diagnostic applications of the
specific antibody. Each primary antibody has also been 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 photographs of microscopic reaction patterns in the Atlas of
Controls are truly unique and will greatly facilitate final quality evaluation of
the antibody markers in laboratories. By providing access to a photo gallery Søren Nielsen
and library of detailed information on appropriate controls in the use of
Director, NordiQC
antibodies – and how to interpret control and reaction patterns – the Atlas of Aalborg University Hospital
Controls should prove to be a valuable tool for all laboratories that perform Denmark
IHC from local clinics and hospitals to large university laboratories. To obtain
the performance portrayed in the Atlas of Controls, the Dako FLEX RTU
antibodies must be used within the system frames established by Agilent.
4
FLEX RTU Concept
Several requirements must be fulfilled for a stain to be optimal. The variation in the staining intensity is a sum
of the total variation of all possible influencing factors.
– Biological variances. The protocol must be able to identify the antigen in normal tissue, with both high and
low expression, and more importantly unknown levels of expression in abnormal tissue. Tumors are known
to exhibit very heterogeneous antigen expression.
– Ischemic time. The protocol should ideally ‘iron out’ different degrees of antigen degradation and retrieval
(to a certain point).
– Time of fixation. The protocol must be able to identify the same level of antigen expression, independent of
the time of fixation within the overall validated timeframe.
– Fixative types. The widespread use of formalin fixation has narrowed this factor.
– Tissue thickness. The protocol should encompass the effects of differences in section thickness on
staining intensity.
The aim when developing optimal IHC protocols is to achieve a robust and correct visualization of the target
antigen in clinical samples with unknown expression levels, thereby contributing to a valid diagnosis.
Optimal protocols
Creating an optimal protocol is – in theory – quite simple: Optimize the protocol parameters to stain:
– Normal tissue elements with high expression of the antigen (HE)
– Normal tissue elements with low expression of the antigen (LE)
– Background staining of non-expressing elements (NE) should not cause risk of misinterpretation of any
positive signal
This “HELENE” concept should be achieved using the same protocol settings for the antibody. Abnormal tissues
of interest should preferably express the antigen within the upper and lower limits of the control tissue elements.
Control Tissue
Atlas of Controls, first edition, shows stains of control tissue for each FLEX RTU antibody in our portfolio. The
stains can be used as guidelines for ensuring that optimal staining results have been achieved when using any
of our FLEX RTU antibodies on our staining platforms.
– High Expression: The tissue type(s) should provide moderate to strong staining intensity in the specified
cell types and cellular structures. Background staining should be non-existing or minimal.
– Low expression: The tissue type(s) should provide weak to moderate staining intensity in the specified cell
types and cellular structures.
– Non-expression: The cell type(s) that should be negative are typically intrinsic, meaning no extra tissue
types are needed for this control.
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How to read
Monoclonal Mouse Anti-Human
Antibody: Cytokeratin 19 Cellular location of
Clone: RCK108 staining reaction
Code: GA615 | IR615 Not applicable
Reaction Location Cytoplasm
Quality Control Liver Tonsil
High Expression Epithelial cells of bile ducts show a moderate to strong staining NA
reaction.
Low Expression NA Squamous epithelial cells focally show a weak to moderate staining
reaction that is strongest in the basal layer.
Non-expression Hepatocytes NA
Tissue type and

magnification
Liver (10x)
Tonsil (20x)
60
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The basis for evaluating the quality of IHC performance is the use of proper controls. Benign tissue that is
easily accessible and interpretable is recommended as control for most antibodies in the FLEX RTU system.
Accompanying photos illustrate the reaction pattern of the cell types and/or cellular structures which should
be identified in the control tissue. These cell types and/or cellular structures are important to identify in order
to monitor appropriate FLEX RTU performance. The quality indicators are divided into high expression (HE,
moderate to strong) and low expression (LE, weak to moderate) structures. When using the FLEX RTU system
on control tissue, it will be normal to find a strong staining reaction in some structures (HE structures) along
with a less strong staining reaction in other structures (LE structures). Negative cells (NE structures) that are
important for evaluation are noted in the non-expression row.
Please note that for some antibodies only HE structures are identified, and for some antibodies no
benign control tissue exists. Usually, many cell types will be negative for each antibody and only important
cell types will be indicated in the Non-expression row.
All stains presented in Atlas of Controls were made by Histology-DK, R&D, Agilent Technologies, Glostrup,
Denmark. All stainings were done according to the protocols in the Instructions for Use for each FLEX RTU
antibody on Dako Omnis or Autostainer Link 48 staining platform, respectively. The slides were scanned on
Philips IntelliSite Pathology Solution and relevant areas of the whole slide image were selected and described
by Søren Nielsen, Director of NordiQC.
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Atlas of Controls - Table of Contents
Actin (Muscle) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Actin (Smooth Muscle) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Alpha-1-Antitrypsin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Alpha-1-Fetoprotein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
AMACR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Amyloid A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
B-Cell-Specific Activator Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
BCL2 Oncoprotein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
BCL6 Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Beta-Catenin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
CA 125 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Calcitonin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Caldesmon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Calretinin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Carcinoembryonic Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
CD1a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
CD2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
CD3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
CD4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
CD5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
CD7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
CD8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
CD10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CD15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
CD19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
CD20cy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
CD21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
CD23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
CD30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
CD31, Endothelial Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
CD34, Class II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
CD43 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
CD45, Leucocyte Common Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
CD56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CD57 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
CD68 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
CD68 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
CD79α . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
CD99, MIC2 Gene Products, Ewing’s Sarcoma Marker . . . . . . . . . . . . . . . . . 48
CD138 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
CD246, ALK Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
CDX-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Chorionic Gonadotropin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Cyclin D1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cytokeratin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Cytokeratin 5/6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Cytokeratin 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Cytokeratin 8/18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Cytokeratin 17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Cytokeratin 18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Cytokeratin 19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Cytokeratin 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Cytokeratin, High Molecular Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Cytomegalovirus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Desmin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
E-Cadherin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Epithelial Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Epithelial Membrane Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Epstein-Barr Virus, LMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
ERCC1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
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Atlas of Controls - Table of Contents
Estrogen Receptor α . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Estrogen Receptor α . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Ets-Related Gene (ERG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Gastrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
GCDFP-15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Glial Fibrillary Acidic Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Helicobacter Pylori . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Hepatocyte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Herpes Simplex Virus Type 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
IgA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
IgD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
IgM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Inhibin α . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Kappa Light Chains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Ki-67 Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Lambda Light Chains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Mammaglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Mast Cell Tryptase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Melan-A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Melanosome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
MUC2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
MUC5AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
MUM1 Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
MutL Protein Homolog 1 (MLH1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
MutS Protein Homolog 2 (MSH2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
MutS Protein Homolog 6 (MSH6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Myeloperoxidase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Myogenin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Myosin Heavy Chain (Smooth Muscle) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Neurofilament Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Neuron-Specific Enolase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Nucleophosmin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Octamer-Binding Transcription Factor 3/4 . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
p53 Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
p63 Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Placental Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Pneumocystis Jiroveci . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Podoplanin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Postmeiotic Segregation Increased 2 (PSM2) . . . . . . . . . . . . . . . . . . . . . . . . 110
Progesterone Receptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Progesterone Receptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Prostate-Specific Membrane Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Prostein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Renal Cell Carcinoma Marker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
S100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Synaptophysin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Terminal Deoxynucleotidyl Transferase (TdT) . . . . . . . . . . . . . . . . . . . . . . . . 118
Thyroglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Thyroid Transcription Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Tyrosinase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Villin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Vimentin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Von Willebrand Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Wilms' Tumor 1 Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
ZAP-70 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
9
Antibody: Actin (Muscle)
Clone: HHF35
Code: IR700
Quality Control Colon/Appendix Tongue
High Expression The smooth muscle cells in the lamina muscularis mucosa show a The striated muscle cells in tongue show a moderate to strong
moderate to strong staining reaction. staining reaction.
Low Expression NA The myoepithelial cells lining the mucous/salivary glands show a
weak to moderate staining reaction.
Non-expression Epithelial cells. NA
Colon (10x)
Tongue (10x)
10
Antibody: Actin (Smooth Muscle)
Clone: 1A4
Code: GA611 | IR611
Quality Control Colon/Appendix Liver
High Expression Smooth muscle cells in the lamina muscularis mucosa show a Smooth muscle cells in large vessels show a moderate to strong
Low Expression NA Smooth muscle cells lining the liver sinusoids show a weak to
moderate staining reaction.
Non-expression Epithelial cells. Hepatocytes
Note: No staining reaction should be seen in appendiceal columnar epithelial cells, lymphocytes or liver cells.
Colon (20x)
Liver (20x)
11
Polyclonal Rabbit Anti-Human
Antibody: Alpha-1-Antitrypsin
Clone: Polyclonal
Code: GA505 | IR505 Not available in the US
Quality Control Tonsil Liver
High Expression Macrophages and neutrophil granulocytes show a moderate to Kupffer cells show a moderate to strong staining reaction.
strong staining reaction.
Low Expression NA Hepatocytes show a weak to moderate staining reaction.
Non-expression Lymphocytes NA
Tonsil (20x)
Liver (20x)
12
Antibody: Alpha-1-Fetoprotein
Clone: Polyclonal
Code: GA500 | IR500
Quality Control Embryonal carcinoma
High Expression Focally, neoplastic cells of embryonal carcinoma show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Embryonal carcinoma (20x)
Embryonal carcinoma (20x)
13
Monoclonal Rabbit Anti-Human
Antibody: AMACR
Clone: 13H4
Code: GA060 | IR060
Quality Control Prostate adenocarcinoma Benign prostatic hyperplasia
High Expression The majority of neoplastic cells show a moderate to strong staining NA
reaction.
Low Expression NA NA
Non-expression NA The epithelial cells of hyperplastic prostate glands are negative or

only show a weak focal staining reaction.
Note: The epithelial cells in normal prostate should be negative or only show a focal staining reaction.
Prostate adenocarcinoma (20x)
Benign prostatic hyperplasia (20x)
14
Antibody: Amyloid A
Clone: mc1
Code: GA605 | IR605
Reaction Location Extracellular and cytoplasm
Quality Control Kidney with amyloidosis Colon with amyloidosis
High Expression Large smooth muscle cells with deposits of amyloid A show a weak NA
to strong staining reaction.
Low Expression Large smooth muscle cells with deposits of amyloid A show a weak Basal cells with amyloid A deposits show a weak to moderate
to strong staining reaction. staining reaction.
Non-expression Normal tissue should be negative. Normal tissue should be negative.
Note: The antibody occasionally labels serum.
Kidney (20x)
Colon (20x)
15
Antibody: B-Cell-Specific Activator Protein
Clone: DAK-Pax5
Code: GA650 | IR650
Reaction Location Nucleus
Quality Control Tonsil
High Expression B cells in the mantle zone and in the germinal center show a moderate to strong staining reaction.
Low Expression NA
Non-expression Squamous epithelial cells.
Note: A diffuse cytoplasmic staining reaction can be observed in cells with intense nuclear staining reaction.
Tonsil (10x)
Tonsil (20x)
16
Antibody: BCL2 Oncoprotein
Clone: 124
Code: IR614
High Expression Interfollicular and mantle zone lymphocytes in the peripheral mantle zone and interfollicular lymphocytes show a moderate to strong
staining reaction.
Low Expression Basal squamous epithelial cells show a weak to moderate staining reaction.
Non-expression Germinal center B cells.
Note: Some follicular lymphomas may be negative due to mutations in the epitope recognized by the antibody.
Tonsil (20x)
Tonsil (10x)
17
Antibody: BCL6 Protein
Clone: PG-B6p
Code: GA625 | IR625
High Expression Germinal center B cells show a moderate to strong staining reaction.
Low Expression Squamous epithelial cells show a weak to moderate staining reaction.
Non-expression NA
Note: Approximately 10% of germinal center T cells in tonsil are labeled.
Tonsil (20x)
Tonsil (20x)
18
Antibody: Beta-Catenin
Clone: β-Catenin-1
Code: GA702 | IR702
Reaction Location Membrane
High Expression Epithelial cells show a moderate to strong staining reaction. Epithelial cells of bile ducts show a moderate to strong
staining reaction.
Low Expression NA Hepatocytes show a weak to moderate staining reaction.
Non-expression NA NA
Note: A weak cytoplasmic reaction is accepted.
Colon (10x)
Liver (20x)
19
Antibody: CA 125
Clone: M11
Code: GA701 | IR701
Reaction Location Membrane and cytoplasm
Quality Control Fallopian tube Appendix
High Expression The apical brush border of the epithelial cells show a moderate to NA
Low Expression NA Follicular dendritic cells in germinal centers of Peyer's patches show
a weak to moderate staining reaction.
Non-expression NA Epithelial cells.
Note: Scattered epithelial cells in fallopian tube also show a cytoplasmic reaction.
Fallopian tube (10x)
Appendix (10x)
20
Antibody: Calcitonin
Clone: Polyclonal
Code: GA515 | IR515
Quality Control Thyroid Medullary thyroid carcinoma
High Expression Scattered parafollicular C cells show a moderate to strong Parafollicular C cells show a moderate to strong staining reaction.
staining reaction.
Note: It is suggested to include a medullary thyroid carcinoma as control.
Thyroid (20x)
Medullary thyroid carcinoma (20x)
21
Antibody: Caldesmon
Clone: h-CD
Code: GA054 | IR054
Quality Control Colon/Appendix Breast or breast hyperplasia
High Expression Smooth muscle cells in the tunica muscularis show a Myoepithelial cells around the ducts show a moderate to strong staining reaction.
moderate to strong staining reaction. Muscle cells in blood vessels show a strong staining reaction.
Non-expression Epithelial cells. Epithelial cells.
Colon (10x)
Breast (20x)
22
Antibody: Calretinin
Clone: DAK-Calret 1
Code: IR627
Reaction Location Nucleus and cytoplasm
Quality Control Colon/Appendix
High Expression Ganglion cells of the peripheral nerves show a moderate to strong staining reaction.
Low Expression Axons of the peripheral nerves show a weak to moderate staining reaction.
Non-expression Epithelial cells.
Note: Peripheral macrophages in colon should also show a nuclear and cytoplasmic staining reaction.
Colon (20x)
Appendix (20x)
23
Antibody: Carcinoembryonic Antigen
Clone: II-7
Code: GA622 | IR622
Quality Control Colon/Appendix Tonsil
High Expression Epithelial cells of the colon mucosa show a moderate to strong staining NA
reaction at the luminal surface with enhancement of the glycocalyx.
Low Expression NA Squamous epithelial cells show focally a weak to moderate
cytoplasmic staining reaction.
Appendix (20x)
Tonsil (20x)
24
Antibody: CD1a
Clone: 010
Code: IR069
Reaction Location Membrane and/or cytoplasm
Quality Control Tonsil Thymus
High Expression The Langerhans’ cells in the squamous epithelium show a moderate The cortical thymocytes show a moderate to strong predominantly
to strong granulated staining reaction. membranous staining reaction.
Note: Staining in germinal center should be disregarded. Staining of smooth muscle cells may be observed.
Tonsil (20x)
Thymus (10x)
25
Antibody: CD2
Clone: AB75
Code: GA651 | IR651
Quality Control Tonsil Colon/Appendix
High Expression Isolated T cells in the germinal centers show a strong staining Intra-epithelial T cells show a weak to strong staining reaction.
reaction whereas T cells in the T zone show a moderate to strong
staining reaction.
Low Expression NA Intra-epithelial T cells show at least a weak to moderate
staining reaction.
Note: Tonsil: Virtually all T cells and NK cells should show a predominantly membranous and cytoplasmic staining reaction.
Tonsil (20x)
Appendix (20x)
26
Antibody: CD3
Clone: Polyclonal
Code: GA503 | IR503
High Expression T cells in the interfollicular areas and in the germinal centers show a Intra-epithelial T cells show a weak to strong staining reaction.
moderate to strong staining reaction.
Low Expression NA Intra-epithelial T cells show at least a weak to moderate
staining reaction.
Non-expression B cells. NA
Tonsil (10x)
Colon (20x)
27
Antibody: CD4
Clone: 4B12
Code: IR649
High Expression Crowded and isolated T-helper cells show a moderate to strong NA
staining reaction.
Low Expression Germinal center macrophages show a weak to moderate Kupffer and endothelial cells of the sinusoids show a weak to
staining reaction. moderate staining reaction.
Non-expression NA Hepatocytes
Tonsil (20x)
Liver (20x)
28
Antibody: CD5
Clone: 4C7
Code: IR082
High Expression Virtually all T cells show a moderate to strong staining reaction. Both crowded T cells in the T zone and scattered T cells in the germinal
center are demonstrated and show a distinct continuous membranous staining reaction.
Low Expression In the mantle zone, scattered B cells show a weak membranous staining reaction.
Non-expression NA
Note: Occasionally, it can be difficult to distinguish the two different lymphocytic subtypes.
Tonsil (10x)
Tonsil (20x)
29
Antibody: CD7
Clone: CBC.37
Code: GA643 | IR643
High Expression Crowded T cells in the T zone show a strong staining reaction. Intra-epithelial T cells show a weak to strong distinct staining
reaction.
Low Expression Isolated T cells show a weak to strong staining reaction. Intra-epithelial T cells show at least a weak to moderate distinct
staining reaction.
Tonsil (20x)
Colon (20x)
30
Antibody: CD8
Clone: C8/144B
Code: GA623 | IR623
High Expression Interfollicular T cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Tonsil (10x)
Tonsil (20x)
31
Antibody: CD10
Clone: 56C6
Code: GA648 | IR648
High Expression Bile canaliculi show a moderate to strong staining reaction. NA
Low Expression NA Germinal center B cells show a weak to moderate staining reaction.
Non-expression NA Peripheral lymphocytes.
Liver (20x)
Tonsil (20x)
32
Antibody: CD15
Clone: Carb-3
Code: GA062 | IR062
Quality Control Tonsil Kidney
High Expression Neutrophiles and eosinophiles show a moderate to strong Proximal and distal tubules show a weak to strong
staining reaction. stainingreaction.
Low Expression NA Proximal and distal tubules show a weak to strong
staining reaction.
Non-expression All other cell types including B and T cells. NA
Tonsil (20x)
Kidney (10x)
33
Antibody: CD19
Clone: LE-CD19
Code: GA656 | IR656
High Expression B cells in the germinal centers and mantle zone show a moderate to NA
strong membrane staining reaction.
Low Expression NA Plasma cells in the lamina propria show a weak to moderate
staining reaction.
Tonsil (10x)
Colon (10x)
34
Antibody: CD20cy
Clone: L26
Code: GA604 | IR604
High Expression Mantle zone and germinal center B cells show a moderate to strong NA
staining reaction.
Low Expression NA Isolated B cells show a weak to moderate staining reaction.
Non-expression Squamous epithelial cells. NA
Tonsil (10x)
Liver (20x)
35
Antibody: CD21
Clone: 1F8
Code: IR608
High Expression Follicular dendritic cells in the germinal centers of tonsil show a moderate to strong staining reaction.
Low Expression A subset of activated B cells in the mantle zone show a weak to moderate staining reaction.
Non-expression NA
Tonsil (20x)
Tonsil (20x)
36
Antibody: CD23
Clone: DAK-CD23
Code: GA781 | IR781
High Expression Follicular dendritic cells in the germinal centers show a moderate to strong staining reaction.
Low Expression B cells in the mantle zone show a weak to moderate staining reaction.
Non-expression Squamous epithelial cells and T cells in the interfollicular T zones.
Tonsil (10x)
Tonsil (20x)
37
Antibody: CD30
Clone: Ber-H2
Code: GA602 | IR602
High Expression Activated inter and perifollicular lymphocytes show a weak to strong membrane and/or a dot-like cytoplasmic staining reaction.
Low Expression Activated inter and perifollicular lymphocytes show a weak to strong membrane and/or a dot-like cytoplasmic staining reaction.
Non-expression NA
Note: Plasma cells may show a focal cytoplasmic staining reaction.
Tonsil (20x)
Tonsil (40x)
38
Antibody: CD31, Endothelial Cell
Clone: JC70A
Code: GA610 | IR610
High Expression Endothelial cells of the large vessels show a moderate to strong Plasma cells show a moderate to strong staining reaction.
staining reaction.
Low Expression Activated B and T cells in lamina propria show a weak to moderate B cells in the mantle zone show a weak to moderate staining
staining reaction. reaction.
Non-expression Columnar epithelial cells. NA
Note: Predominantly membrane staining, with weaker cytoplasmic staining
Colon (20x)
Tonsil (20x)
39
Antibody: CD34, Class II
Clone: QBEnd 10
Code: GA632 | IR632
Quality Control Liver Colon/Appendix
High Expression Endothelial cells of portal vessels and of the periportal sinusoids Endothelial cells of all vessels show a distinct predominantly
show a moderate to strong staining reaction. membranous staining reaction.
Note: Especially, the endothelial cells of the small submucosal vessels should be demonstrated.
Liver (20x)
Appendix (20x)
40
Antibody: CD43
Clone: DF-T1
Code: GA636 | IR636
High Expression Virtually all T cells show a moderate to strong staining reaction. T cells and plasma cells in lamina propria show a moderate to strong
staining reaction.
Low Expression Macrophages, e.g. within germinal centers, show a weak to Macrophages show a weak to moderate staining reaction.
Tonsil (20x)
Appendix (20x)
41
Antibody: CD45, Leucocyte Common Antigen
Clone: 2B11 + PD7/26
Code: GA751 | IR751
Quality Control Tonsil Brain
High Expression B and T cells show a moderate to strong staining reaction. NA
Low Expression NA Microglial cells show a weak to moderate staining reaction.
Tonsil (10x)
Brain (20x)
42
Antibody: CD56
Clone: 123C3
Code: IR628
High Expression Ganglion cells and axons of the Auerbach’s and Meissner's plexus NA
show a moderate to strong staining reaction.
Low Expression NA Isolated T cells (NK cells) in the interfollicular areas show a weak to
Colon (20x)
Tonsil (20x)
43
Antibody: CD57
Clone: TB01
Code: GA647 | IR647
High Expression NK/T cells in the T zone and at the edge of the germinal centers show NA
a moderate to strong cytoplasmic and/or membrane staining reaction.
Low Expression NA Schwann cells and scattered neurons, in e.g. the Auerbach's and
Meissner's plexus, show a weak to moderate cytoplasmic and/or
membrane staining reaction.
Note: The NK cells typically show a weaker staining than T cells.
Tonsil (20x)
Appendix (20x)
44
Antibody: CD68
Clone: KP1
Code: GA609 | IR609
High Expression Macrophages in the germinal centers show a moderate to strong NA

staining reaction.
Non-expression Germinal center B cells. NA
Note: In the interfollicular areas of tonsil, the granulocytes and macrophages should show a granular cytoplasmic staining reaction.
Tonsil (20x)
Brain (20x)
45
Antibody: CD68
Clone: PG-M1
Code: GA613 | IR613
High Expression Macrophages in the germinal centers show a moderate to strong NA

staining reaction.
Non-expression Germinal center B cells. NA
Note: In the interfollicular areas of tonsil, the granulocytes and macrophages should show a granular cytoplasmic staining reaction.
Tonsil (10x)
Brain (20x)
46
Antibody: CD79α
Clone: JCB117
Code: GA621 | IR621
High Expression Plasma cells show strong cytoplasmic staining reaction. B cells in the mantle zone show a moderate to strong predominantly membranous
staining reaction.
Low Expression B cells in the germinal centers show a weak to moderate staining reaction.
Non-expression Squamous epithelial cells and T cells.

Note: Plasma cells should show a strong cytoplasmic staining reaction.
Tonsil (10x)
Tonsil (20x)
47
Antibody: CD99, MIC2 Gene Products, Ewing’s Sarcoma Marker
Clone: 12E7
Code: IR057
Quality Control Thymus
High Expression Cortical thymocytes show moderate to strong membranous staining reaction.
Low Expression Dispersed medullary thymocytes show weak to moderate membranous staining reaction.
Non-expression NA
Thymus (10x)
Thymus (20x)
48
Antibody: CD138
Clone: MI15
Code: GA642 | IR642
High Expression Plasma cells show a moderate to strong staining reaction. The majority of the plasma cells in lamina propria show a moderate to strong
staining reaction. The luminal and basal epithelial cells are demonstrated.
Low Expression Epithelial cells should show a weak to moderate staining NA
reaction.
Non-expression The majority of the germinal center cells and peripheral NA
lymphocytes.
Tonsil (20x)
Colon (20x)
49
Antibody: CD246, ALK Protein
Clone: ALK1
Code: GA641 | IR641
Reaction Location Nucleus and/or cytoplasm
Quality Control Anaplastic large cell lymphoma with t(2;5) translocation
High Expression Neoplastic cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Note: A strong staining in nuclei and a weaker cytoplasmic staining is often seen.
Anaplastic large cell lymphoma (40x)
Anaplastic large cell lymphoma (40x)
50
Antibody: CDX-2
Clone: DAK-CDX-2
Code: GA080 | IR080
Quality Control Appendix Pancreas
High Expression Columnar epithelial cells show a moderate to strong NA

staining reaction.
Low Expression NA Ductal and scattered intercalated epithelial cells show a weak to
Appendix (10x)
Pancreas (20x)
51
Antibody: Chorionic Gonadotropin
Clone: Polyclonal
Code: GA508 | IR508
Quality Control Placenta
High Expression Trophoblasts and syncytiotrophoblasts show a moderate to strong staining reaction.
Low Expression Macrophages and serum show a weak staining reaction.
Non-expression Stroma cells.
Note: The staining pattern in placenta may vary depending on pregnancy stage.
Placenta (20x)
Placenta (20x)
52
Antibody: Cyclin D1
Clone: EP12
Code: GA083 | IR083
High Expression Suprabasal squamous epithelial cells show a weak to strong staining reaction.
Low Expression Scattered endothelial cells show a weak to moderate staining reaction.
Non-expression Vast majority of lymphoid cells.
Note: A weak cytoplasmic staining reaction together with the specific nuclear reaction is acceptable.
Tonsil (20x)
Tonsil (20x)
53
Antibody: Cytokeratin
Clone: AE1/AE3
Code: GA053 | IR053
Quality Control Liver
High Expression Bile ducts cells show a moderate to strong staining reaction.
Low Expression Hepatocytes show a weak to moderate, predominantly membranous, staining reaction.
Non-expression Stroma cells.
Note: The interdigitating reticulum cells in lymphoid tissue can be positive.
Liver (10x)
Liver (20x)
54
Antibody: Cytokeratin 5/6
Clone: D5/16 B4
Code: GA780 | IR780
Quality Control Tonsil Prostate
High Expression Squamous epithelial cells show a moderate to strong Basal cells show a moderate to strong cytoplasmic staining reaction
staining reaction. with no or only focal reaction in the secretory cells.
Note: The staining reaction is seen in all cell layers in the epithelial surface.
Tonsil (20x)
Prostate (20x)
55
Antibody: Cytokeratin 7
Clone: OV-TL12/30
Code: GA619 | IR619
Quality Control Pancreas
High Expression Epithelial cells of the large acinar ducts show a moderate to strong staining reaction.
Low Expression Epithelial cells of intercalating pancreatic ducts show a weak to moderate staining reaction.
Non-expression Pancreatic acinar cells.
Pancreas (20x)
Pancreas (40x)
56
Antibody: Cytokeratin 8/18
Clone: EP17/EP30
Code: IR094
High Expression Epithelial cells of bile ducts show a moderate to strong Reactive squamous epithelial cells show a moderate to strong
staining reaction. staining reaction.
Low Expression Hepatocytes show a weak to moderate staining reaction. NA
Note: Staining of interdigitating reticulum cells may be observed within lymphoid tissues.
Liver (20x)
Tonsil (10x)
57
Clone: E3
Code: IR620
Reaction Location Cytoplasm and/or membrane
Quality Control Skin Breast hyperplasia
High Expression Myoepithelial cells of the sweat glands show a moderate to strong Myoepithelial cells of the epithelial glands show a strong and distinct
staining reaction. staining reaction with no staining in the epithelial cells.
Non-expression Normal gland epithelial cells and squamous epithelial cells. NA
Note: Some gland epithelial cells may display staining of cytoplasm.
Skin (20x)
Breast hyperplasia (20x)
58
Clone: DC10
Code: GA618 | IR618
High Expression Epithelial cells of the bile ducts show a moderate to strong staining reaction.
Low Expression Membranes of hepatocytes show a weak to moderate staining reaction.
Non-expression Kupffer cells.
Note: The staining reaction can be heterogeneous with the strongest staining reaction in the periportal zones.
Liver (10x)
Liver (20x)
59
Clone: RCK108
Code: GA615 | IR615
High Expression Epithelial cells of bile ducts show a moderate to strong staining NA
reaction.
Low Expression NA Squamous epithelial cells focally show a weak to moderate staining
reaction that is strongest in the basal layer.
Liver (10x)
Tonsil (20x)
60
Clone: Ks20.8
Code: GA777 | IR777
High Expression In columnar epithelium, the luminal cells show a moderate to strong staining reaction.
Low Expression Basal to intermediate cells show a weak to moderate staining reaction.
Non-expression NA
Note: Endocrine cells in basal crypts should show a moderate to strong staining reaction.
Appendix (10x)
Appendix (20x)
61
Antibody: Cytokeratin, High Molecular Weight
Clone: 34βE12
Code: GA051 | IR051
Quality Control Tonsil Prostate
High Expression Squamous epithelial cells show a moderate to strong Basal cells show a strong cytoplasmic staining reaction with no or
staining reaction. only focal reaction in the secretory cells.
Note: The staining reaction is seen in all cell layers in the epithelial surface.
Tonsil (20x)
Prostate (20x)
62
Monoclonal Mouse Anti-
Antibody: Cytomegalovirus
Clone: CCH2 + DDG9
Quality Control Cytomegalovirus-infected tissue
High Expression Cells infected with cytomegalovirus show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Note: No background staining should be seen.
Cytomegalovirus-infected tissue (20x)
Cytomegalovirus-infected tissue (40x)
63
Antibody: Desmin
Clone: D33
Code: IR606
Quality Control Colon/Appendix Striated muscle
High Expression Smooth muscle cells in the tunica muscularis show a moderate to Muscle cells in the Z-bands show strong staining reaction.
Low Expression Smooth muscle cells in the small vessels in the lamina propria show NA
a weak to moderate staining reaction.
Non-expression Columnar epithelial cells. NA
Appendix (10x)
Striated muscle (40x)
64
Antibody: E-Cadherin
Clone: NCH-38
Code: GA059 | IR059
High Expression Columnar epithelial cells show a moderate to strong Bile ductal cells show a moderate to strong reaction.
staining reaction.
Low Expression NA Hepatocytes show at least weak to moderate staining reaction.
Appendix (20x)
Liver (20x)
65
Antibody: Epithelial Antigen
Clone: Ber-EP4
Code: GA637 | IR637
Quality Control Colon/Appendix Kidney
High Expression Columnar epithelial cells show a moderate to strong Epithelial cells in the collecting ducts and distal tubules show a
staining reaction. moderate to strong staining reaction.
Low Expression NA Epithelial cells lining the bowman capsule show a weak to moderate
staining reaction.
Non-expression Lymphocytes, apart from cytoplasmic staining reaction in NA
macrophages in lamina propria.
Appendix (20x)
Kidney (20x)
66
Antibody: Epithelial Membrane Antigen
Clone: E29
Code: GA629 | IR629
Quality Control Tonsil Breast
High Expression Squamous epithelial cells show a moderate to strong cytoplasmic Ductal epithelial cells show a moderate to strong membranous
Low Expression Plasma cells show a weak to moderate staining reaction. NA
Note: A granular cytoplasmic staining reaction can also be observed.
Tonsil (20x)
Breast (20x)
67
Antibody: Epstein-Barr Virus, LMP
Clone: CS.1-4
Code: IR753 Not available in the US
Quality Control Burkitt lymphoma/leukemia (EBV+)
High Expression Neoplastic cells show a moderate to strong predominantly membranous, but also cytoplasmic staining reaction.
Low Expression NA
Non-expression NA
Note: Occasionally, the staining reaction shows a dot-like pattern.
Burkitt lymphoma (40x)
Burkitt lymphoma (40x)
68
Antibody: ERCC1
Clone: 4F9
Code: IR091
High Expression Glandular epithelium, lymphocytes and stromal cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Note: Cytoplasmic staining in the presence of nuclear staining may also be observed.
Appendix (10x)
Appendix (20x)
69
Antibody: Estrogen Receptor α
Clone: 1D5
Code: IR657 Not available in the US
Quality Control Cervix
High Expression Columnar epithelial cells and stromal cells show a moderate to strong staining reaction.
Low Expression Intermediate and superficial squamous epithelial cells show a weak to moderate staining reaction.
Non-expression Endothelial cells and lymphocytes.
Cervix (10x)
Cervix (20x)
70
Antibody: Estrogen Receptor α
Clone: EP1
Code: GA084 | IR084
Quality Control Cervix Breast hyperplasia
High Expression Columnar epithelial cells and stromal cells show a moderate to The neoplastic cells show a weak to strong staining reaction.
Low Expression Intermediate and superficial squamous epithelial cells show a weak The neoplastic cells show a weak to strong staining reaction.
to moderate staining reaction.
Non-expression Endothelial cells and lymphocytes. NA
Cervix (20x)
71
Antibody: Ets-Related Gene (ERG)
Clone: EP111
Code: GA659 | IR659
High Expression Endothelial cells show a moderate to strong staining reaction. Endothelial cells show a moderate to strong staining reaction.
Note: Peripheral lymphocytes may show a weak staining reaction.
Tonsil (20x)
Colon (20x)
72
Antibody: Gastrin
Clone: Polyclonal
Code: GA519 | IR519
Quality Control Stomach
High Expression G cells in the pyloric antrum show moderate to strong staining reaction.
Low Expression NA
Note: Occasionally, a slightly diffuse background reaction in the vicinity of G cells can be observed.
Stomach (10x)
Stomach (40x)
73
Antibody: GCDFP-15
Clone: 22A3
Code: GA077 | IR077
Quality Control Breast hyperplasia Skin
High Expression Glandular and ductal epithelial cells show at least a moderate to Epithelial cells of the sweat glands show a moderate to
strong focal staining reaction. strong, at least focally, staining reaction.
Non-expression NA Squamous epithelial cells.
Note: A weak background staining can be expected.
Skin (20x)
74
Antibody: Glial Fibrillary Acidic Protein
Clone: Polyclonal
Code: GA524 | IR524
Quality Control Brain Colon
High Expression Astrocytes show a moderate to strong staining reaction. NA
Low Expression NA Ganglion cells in the Auerbach's and Meissner's plexus show a weak
to moderate staining reaction.
Brain (20x)
Colon (20x)
75
Polyclonal Rabbit Anti-
Antibody: Helicobacter Pylori
Clone: Polyclonal
Reaction Location Bacteria
Quality Control Gastric mucosa
High Expression Helicobacter pylori bacteria lining gastric mucosa show a weak to strong staining reaction.
Low Expression Helicobacter pylori bacteria lining gastric mucosa show a weak to strong staining reaction.
Non-expression No staining reaction is seen in the epithelial cells. In the lamina propria, scattered macrophages can show a staining reaction.
Note: Precipitates may form in the tissue during the IHC staining procedure, which in some cases can resemble Helicobacter Pylori staining. It is therefore essential to
always use normal tissue known to be negative for Helicobacter Pylori to identify unexpected precipitates.
Gastric (20x)
Gastric (40x)
76
Antibody: Hepatocyte
Clone: OCH1E5
Code: GA624 | IR624
High Expression Hepatocytes show a moderate to strong staining reaction.
Low Expression NA
Non-expression Bile duct epithelial cells.
Liver (10x)
Liver (20x)
77
Antibody: Herpes Simplex Virus Type 1
Clone: Polyclonal
Quality Control Lesion with HSV
High Expression T Cells infected with herpes simplex virus (type 1 or type 2) show a moderate to strong staining reaction.
Low Expression T Cells infected with herpes simplex virus (type 1 or type 2) show a weak to moderate staining reaction.
Non-expression NA
Note: The staining reaction intensity may vary from low to high depending of the level of protein expression.
Esophagus (10x)
Liver (20x)
78
Antibody: IgA
Clone: Polyclonal
Code: GA510 | IR510
High Expression Plasma cells and germinal center immunoblasts show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Tonsil (20x)
Tonsil (20x)
79
Antibody: IgD
Clone: Polyclonal
Code: IR517
High Expression Mantle zone B cells show a moderate to strong, predominantly membranous reaction. Dispersed plasma cells show a moderate to strong
Low Expression NA
Non-expression The background should be negative or show only a minimal staining reaction.
Tonsil (10x)
Tonsil (20x)
80
Antibody: IgG
Clone: Polyclonal
Code: GA512 | IR512
High Expression Plasma cells and germinal center immunoblasts show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Note: In bone marrow, the majority of plasma cells show a strong cytoplasmic staining reaction.
Tonsil (20x)
Tonsil (20x)
81
Antibody: IgM
Clone: Polyclonal
Code: GA513 | IR513
High Expression Virtually all the mantle zone B cells show a moderate to strong membranous staining reaction, while immunoblasts and plasma cells in the
germinal center show a strong cytoplasmic staining reaction.
Low Expression NA
Non-expression NA
Note: Some background reaction in serum, connective tissue and epithelial cells may be observed.
Tonsil (10x)
Tonsil (20x)
82
Antibody: Inhibin α
Clone: R1
Code: GA058 | IR058
Quality Control Testis Placenta
High Expression Leydig cells and the Sertoli cells show a moderate to strong distinct NA
granular staining reaction.
Low Expression NA Thropho- and syncytiotrophoblasts show a weak to moderate
staining reaction.
Note: Occasionally, a weak to moderate coexisting nuclear staining reaction can be observed.
Testis (20x)
Placenta (20x)
83
Polyclonal Guinea Pig Anti-
Antibody: Insulin
Clone: Polyclonal
Code: IR002
Quality Control Pancreas
High Expression B cells in the islets of Langerhans show a moderate to strong staining reaction.
Low Expression NA
Non-expression Acinar epithelial cells.
Pancreas (10x)
Pancreas (20x)
84
Antibody: Kappa Light Chains
Clone: Polyclonal
Code: GA506 | IR506
High Expression Immunoblasts and plasma cells in the germinal center show moderate to strong cytoplasmic staining.
Low Expression Approximately 50% of the mantle zone B cells show a weak to moderate membranous staining reaction.
Non-expression All T and B cells with lambda light chain expression.
Tonsil (10x)
Tonsil (20x)
85
Antibody: Ki-67 Antigen
Clone: MIB-1
Code: GA626 | IR626
High Expression Germinal center B cells of the dark zone show a moderate to strong staining reaction.
Low Expression Basal and parabasal squamous epithelial cells show a weak to moderate staining reaction.
Non-expression NA
Note: In mitotic cells, the chromosomes and the cytoplasm are labeled.
Tonsil (20x)
Tonsil (10x)
86
Antibody: Lambda Light Chains
Clone: Polyclonal
Code: GA507 | IR507
High Expression Immunoblasts and plasma cells in the germinal center show moderate to strong cytoplasmic staining.
Low Expression Approximately 50% of the mantle zone B cells show weak to moderate membranous staining reaction.
Non-expression All T and B cells with kappa light chain expression.
Tonsil (20x)
Tonsil (20x)
87
Antibody: Mammaglobin
Clone: 304-1A5
Code: GA074 | IR074
Quality Control Skin Breast hyperplasia
High Expression Epithelial cells in sweat glands show at least a focal, moderate to At least focally, ductal epithelial cells show moderate to strong
strong staining reaction. staining reaction.
Skin (20x)
88
Antibody: Mast Cell Tryptase
Clone: AA1
Code: IR640
High Expression Mast cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression Lymphocytes
Note: Occasionally, a weak and diffuse staining pattern in the vicinity of the labeled cells may be seen.
Tonsil (10x)
Tonsil (20x)
89
Antibody: Melan-A
Clone: A103
Code: IR633
Quality Control Skin Adrenal gland
High Expression Melanocytes in the basal layer of the epidermis show a moderate to NA
Low Expression NA Virtually all the adrenal cortical cells show a weak to moderate
granular staining reaction throughout all zones of the gland.
Skin (20x)
Adrenal gland (20x)
90
Antibody: Melanosome
Clone: HMB45
Code: GA052 | IR052
Quality Control Nevus Kidney (not shown)
High Expression The nevus cells in the dermis show a weak to strong NA
staining reaction.
Low Expression The nevus cells in the dermis show a weak to strong NA
staining reaction.
Note: Normal resting melanocytes in skin are typically not demonstrated by the antibody.
Nevus (20x)
Nevus (20x)
91
Antibody: MUC2
Clone: CCP58
Code: IR658
High Expression Goblet cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Appendix (10x)
Appendix (20x)
92
Antibody: MUC5AC
Clone: CLH2
Code: IR661
Reaction Location Cytoplasm and/or nucleus
Quality Control Cervix Gastric
High Expression Columnar epithelial cells show a moderate to strong Foveolar and mucopeptic neck cells show a moderate to strong
Cervix (10x)
Gastric (20x)
93
Antibody: MUM1 Protein
Clone: MUM1p
Code: GA644 | IR644
High Expression Plasma cells show a moderate to strong predominantly nuclear NA

staining reaction.
Low Expression NA Activated B cells show a weak to moderate predominantly nuclear
staining reaction.
Note: Interfollicular cells show a moderate to strong nuclear staining reaction. Only a minimal cytoplasmic staining reaction should be seen.
Colon (20x)
Tonsil (20x)
94
Antibody: MutL Protein Homolog 1 (MLH1)
Clone: ES05
Code: IR079
High Expression Basal epithelial cells show a moderate to strong staining reaction. Germinal center cells show a moderate to strong staining reaction.
Low Expression Luminal epithelial cells and smooth muscle cells at least show a Mantle zone B and T cells show a weak to moderate staining
weak to moderate staining reaction. reaction.
Note: Delayed fixation or long term storage of cut sections may reduce staining intensity which may impact interpretation.
Appendix (20x)
Tonsil (20x)
95
Antibody: MutS Protein Homolog 2 (MSH2)
Clone: FE11
Code: IR085
High Expression Basal epithelial cells show a moderate to strong staining reaction. Germinal center cells show a moderate to strong staining reaction.
Low Expression Luminal epithelial cells and smooth muscle cells at least show a Mantle zone B and T cells show a weak to moderate
weak to moderate staining reaction. staining reaction.
Appendix (20x)
Tonsil (20x)
96
Antibody: MutS Protein Homolog 6 (MSH6)
Clone: EP49
Code: IR086
High Expression Virtually all cells show a distinct nuclear staining reaction. The basal epithelial cells and germinal center cells in lymphoid follicles show a
Low Expression Luminal epithelial cells and stromal cells should at least show a weak to moderate staining reaction.
Non-expression NA
Appendix (20x)
Colon (20x)
97
Antibody: Myeloperoxidase
Clone: Polyclonal
Code: GA511 | IR511
High Expression Neutrophils and Kupffer cells show a moderate to strong granular Neutrophils and eosinophils in the interfollicular zones and the
cytoplasmic staining reaction. germinal center macrophages show a moderate to strong granular
Non-expression Hepatocytes (or only weak staining reaction). NA
Liver (20x)
Tonsil (20x)
98
Antibody: Myogenin
Clone: F5D
Code: GA067 | IR067
Quality Control Rhabdomyosarcoma Leiomyosarcoma (not shown)
High Expression At least focally, neoplastic cells show a moderate to strong NA

nuclear staining reaction and no, or only a minimal, cytoplasmic
staining reaction.
Non-expression NA Neoplastic cells.
Rhabdomyosarcoma (10x)
Rhabdomyosarcoma (20x)
99
Antibody: Myosin Heavy Chain (Smooth Muscle)
Clone: SMMS-1
Code: IR066
Quality Control Breast Uterus
High Expression Myoepithelial show a moderate to strong staining reaction. NA
Low Expression Smooth muscle cells of small vessels show a weak to moderate Smooth muscle cells of the myometrium show a weak to moderate
Breast (20x)
Uterus (20x)
100
Antibody: Neurofilament Protein
Clone: 2F11
Code: GA607 | IR607
High Expression Large axons and ganglion cells in Auerbach’s plexus show a moderate to strong staining reaction.
Low Expression Isolated axons in the muscularis externa show a weak to moderate staining reaction.
Non-expression Smooth muscle cells and epithelium
Colon (20x)
Colon (20x)
101
Antibody: Neuron-Specific Enolase
Clone: BBS/NC/VI-H14
Code: IR612
Quality Control Colon/Appendix Pancreas
High Expression Ganglion cells of the Auerbach’s plexus show a moderate to Langerhans’ islets and single neuroendocrine cells in the pancreatic
strong cytoplasmic and nuclear staining reaction. ducts show a moderate to strong granular cytoplasmic and nuclear
staining reaction.
Low Expression Isolated axons in the muscularis externa show a weak to NA
moderate cytoplasmic staining reaction.
Appendix (20x)
Pancreas (20x)
102
Antibody: Nucleophosmin
Clone: 376
Code: GA652 | IR652
Quality Control Liver Brain
High Expression The vast majority of hepatocytes show a moderate to strong nuclear Normal neurons show a moderate to strong distinct nuclear
Low Expression Scattered mitotic and post-mitotic cells show a weak to moderate Large Purkinje cells and some small neurons show a weak to
cytoplasmic and nuclear staining reaction. moderate cytoplasmic staining reaction.
Note: Some nuclei in liver and brain are negative.
Liver (20x)
Brain (20x)
103
Antibody: Octamer-Binding Transcription Factor 3/4
Clone: N1NK
Code: IR092
Quality Control Seminoma
High Expression The majority of neoplastic cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression Placenta or colon/appendix can serve as negative tissue control showing no nuclear staining reaction.
Note: Weakly positive immunostaining in the cytoplasm of epithelial cells was observed in epithelia of the testis, stomach, and small intestine.
Seminoma (10x)
Seminoma (20x)
104
Antibody: p53 Protein
Clone: DO-7
Code: GA616 | IR616
Quality Control Colon adenocarcinoma Colon/Appendix
High Expression Neoplastic cells show a moderate to strong staining reaction. NA
Low Expression Scattered benign basal epithelial cells show a weak to moderate Scattered basal epithelial cells show a weak to moderate
Non-expression The vast majority of normal epithelial cells. The vast majority of normal epithelial cells.
Note: Basal cells may show a weak to moderate nuclear staining reaction.
Colon adenocarcinoma (20x)
Colon (20x)
105
Antibody: p63 Protein
Clone: DAK-p63
Code: GA662 | IR662
Reaction Location Nuclear
High Expression Squamous epithelial cells show a moderate to strong staining reaction.
Low Expression Dispersed lymphocytes and endothelial cells show a weak to moderate staining.
Non-expression NA
Note: Occasionally, cytoplasmic labeling of granulocytes may be observed.
Tonsil (20x)
Tonsil (20x)
106
Antibody: Placental Alkaline Phosphatase
Clone: 8A9
Code: IR779
Quality Control Placenta
High Expression The brush border of the syncytiotrophoblast and trophoblast shows a moderate to strong, predominantly membranous, staining reaction.
Low Expression Cytoplasmic compartment of the syncytiotrophoblast and trophoblast shows a weak to moderate staining reaction.
Non-expression NA
Note: Some cytoplasmic staining in the smooth muscle cells and myofibroblasts is acceptable.
Placenta (20x)
Placenta (20x)
107
Antibody: Pneumocystis Jiroveci
Clone: 3F6
Code: IR635
Quality Control Lung (P. jiroveci infection)
High Expression P. jiroveci cyst walls show a moderate to strong staining reaction.
Low Expression Trophozites show a weak to moderate, diffuse and granular, staining reaction.
Non-expression Epithelial or lymphatic cells.
Lung (20x)
Lung (40x)
108
Antibody: Podoplanin
Clone: D2-40
Code: IR072
Quality Control Appendix
High Expression Lymphatic endothelial cells show a moderate to strong predominantly cytoplasmic staining reaction.
Low Expression Cajal cells of the muscularis propria show a weak to moderate predominantly membranous staining reaction.
Non-expression Vascular endothelial cells.
Appendix (20x)
Appendix (20x)
109
Antibody: Postmeiotic Segregation Increased 2 (PSM2)
Clone: EP51
Code: IR087
High Expression Virtually all cells show a distinct nuclear staining reaction. The basal epithelial cells and germinal center cells in lymphoid follicles show a
Low Expression Luminal epithelial cells and stromal cells should at least show a weak to moderate staining reaction.
Non-expression NA
Appendix (20x)
Colon adenocarcinoma (20x)
110
Antibody: Progesterone Receptor
Clone: PgR 636
Code: IR068
High Expression Columnar epithelial cells and the stromal cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression No staining reaction should be seen in tonsil.
Note: Some cytoplasmic staining is acceptable.
Cervix (20x)
111
Antibody: Progesterone Receptor
Clone: PgR 1294
Code: GA090
High Expression Columnar epithelial cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression No nuclear staining reaction should be seen in tonsil.
Note: Not all uterine cervix will show the described staining pattern. Cytoplasmic labeling, if observed, should be regarded as non-specific.
Cervix (20x)
112
Antibody: Prostate-Specific Membrane Antigen
Clone: 3E6
Code: IR089
Quality Control Prostate
High Expression Columnar epithelial cells show a moderate to strong staining reaction.
Low Expression NA
Non-expression NA
Note: Prostate-specific membrane antigen may also be expressed in a subset of non-prostatic tissues
Prostate (10x)
Prostate (20x)
113
Antibody: Prostein
Clone: 10E3
Code: IR088
Quality Control Prostate
High Expression Columnar epithelial cells show a moderate to strong granular staining reaction.
Low Expression NA
Non-expression All other cells in prostate.
Note: Prostein expression has not been detected in other normal or malignant glandular tissues with the exception of few urothelial carcinomas.
Prostate (10x)
Prostate (20x)
114
Antibody: Renal Cell Carcinoma Marker
Clone: SPM314
Code: GA075 | IR075
Quality Control Kidney
High Expression Epithelial cells of the proximal tubules show a moderate to strong, predominantly membranous, staining reaction.
Low Expression Epithelial cells in focal areas of the Bowman’s capsule show weak to moderate staining reaction.
Non-expression NA
Note: Cytoplasmic staining may be observed.
Kidney (10x)
Kidney (20x)
115
Antibody: S100
Clone: Polyclonal
Code: GA504 | IR504
High Expression Satellite and Schwann cells of the peripheral nerves in Auerbach's plexus show a moderate to strong staining reaction.
Low Expression Adipocytes show a weak to moderate staining reaction.
Non-expression Epithelial and smooth muscle cells.
Colon (20x)
Colon (20x)
116
Antibody: Synaptophysin
Clone: DAK-SYNAP
Code: GA660 | IR660
High Expression Peripheral nerves in the tunica muscularis show a moderate to strong staining reaction.
Low Expression Endocrine cells in the epithelial surface show a weak to moderate staining reaction.
Note: Occasionally, cytoplasmic labeling of goblet cells in colon and small intestine can be observed.
Colon (20x)
Colon (20x)
117
Antibody: Terminal Deoxynucleotidyl Transferase (TdT)
Clone: EP266
Code: IR093
Quality Control Thymus
High Expression The subcapsullar and cortical thymocytes show a moderate to strong staining reaction.
Low Expression NA
Non-expression Medullar thymocytes.
Thymus (10x)
Thymus (20x)
118
Antibody: Thyroglobulin
Clone: Polyclonal
Code: GA509 | IR509
Quality Control Thyroid
High Expression Extracellular colloid shows a moderate to strong staining reaction.
Low Expression Columnar follicular epithelial cells show a weak to moderate staining reaction.
Non-expression NA
Thyroid (20x)
Thyroid (40x)
119
Antibody: Thyroid Transcription Factor
Clone: 8G7G3/1
Code: IR056
Quality Control Thyroid Lung
High Expression Thyroid follicular epithelial cells show a moderate to strong staining Type II pneumocyte cells lining the alveolar walls show a moderate
reaction. to strong staining reaction.
Note: Occasionally, a weak staining reaction may be observed in columnar epithelial cells of the respiratory ducts.
Thyroid (20x)
Lung (20x)
120
Antibody: Tyrosinase
Clone: T311
Code: IR061
Quality Control Nevus Skin
High Expression Nevus cells of the dermis and the melanocytes in the basal layer of NA
the epidermis show a moderate to strong staining reaction.
Low Expression NA Melanocytes in the basal layer of the epidermis show a weak to
Nevus (20x)
Nevus (20x)
121
Antibody: Villin
Clone: 1D2 C3
Code: IR076
High Expression Epithelial cells show a moderate to strong predominantly NA

membranous staining reaction. The cytoplasm will typically show a
diffuse and weak staining reaction.
Low Expression NA Hepatocytes show a weak to moderate membranous staining
reaction with no, or only a minimal, cytoplasmic staining reaction.
Non-expression Lymphocytes in lamina propria. NA
Note: Cytoplasmic staining may be accompanied by nuclear staining.
Colon (20x)
Liver (20x)
122
Antibody: Vimentin
Clone: V9
Code: GA630 | IR630
High Expression Lymphocytes and endothelial cells show a moderate to strong Kupffer cells and lymphocytes show a moderate to strong
Low Expression NA Sinusoid smooth muscle cells show a weak to moderate
staining reaction.
Non-expression NA Hepatocytes
Tonsil (10x)
Liver (20x)
123
Antibody: Von Willebrand Factor
Clone: Polyclonal
Code: GA527 | IR527
Quality Control Appendix/Colon Liver
High Expression Endothelial cells in the vessels in the lamina propria show a Endothelial cells in large vessels show a moderate to strong
Low Expression NA Endothelial cells lining the sinusoids show a weak to moderate
staining reaction.
Colon (20x)
Liver (10x)
124
Antibody: Wilms' Tumor 1 Protein
Clone: 6F-H2e
Code: IR055
Quality Control Fallopian tube
High Expression Epithelial cells and the majority of stromal smooth muscle cells show a moderate to strong nuclear staining reaction. A weak cytoplasmic
background staining in these cells is accepted.
Low Expression NA
Non-expression NA
Note: Endothelial cells will typically show a moderate to strong cytoplasmic staining reaction.
125
Antibody: ZAP-70
Clone: 2F3.2
Code: IR653
High Expression Isolated T cells in the germinal center show a moderate to strong staining reaction.
Low Expression Crowded T cells in the T zone show a weak to moderate staining reaction.
Non-expression Germinal center B cells.
Tonsil (10x)
Tonsil (40x)
126
127
Appendix
On-slide controls
We recommend using small, core tissue sections attached to the same glass slide as the test specimen for
each staining. For inspiration we have suggested three different, standard control sets of five tissue cores
which will cover over 75% of the FLEX RTU antibodies in this Atlas of Controls.
Control Set A Control Set B Control Set C
Tonsil Tonsil Breast/Breast hyperplasia

Colon Kidney Skin/Nevus
Appendix Brain Placenta
Liver Prostate Thyroid
Pancreas Thymus Cervix
Glass slide with on-slide control tissue
Control Set A
Control tissue cores
Specimen
The recommendation of on-slide control tissue cores in these combinations is by no means intended to
override the Instructions for Use and the professional judgment of a certified pathologist. The contents
are provided as information only, and Agilent Dako neither claims nor warrants the universal validity of the
information provided as there are national and professional differences in the acceptance of the relevance
of various markers and related quality control tissues.
128
Antibody Clone Code Quality Control Quality Control Liver Prostate Thyroid
#1 #2 Pancreas Thymus Cervix
Actin (Muscle) HHF35 IR700 Colon/Appendix Tongue
Actin (Smooth Muscle) 1A4 GA611 IR611 Colon/Appendix Liver A
Alpha-1-Antitrypsin Polyclonal GA505 IR505 Tonsil Liver A
Alpha-1-Fetoprotein Polyclonal GA500 IR500 Embryonal NA
carcinoma
AMACR 13H4 GA060 IR060 Prostate Benign prostatic
adenocarcinoma hyperplasia
Amyloid A mc1 GA605 IR605 Kidney with Colon with

amyloidosis amyloidosis
B-Cell-Specific Activator Protein DAK-Pax5 GA650 IR650 Tonsil NA A
BCL2 Oncoprotein 124 IR614 Tonsil NA A
BCL6 Protein PG-B6p GA625 IR625 Tonsil NA A
Beta-Catenin β-Catenin-1 GA702 IR702 Colon/Appendix Liver A
CA 125 M11 GA701 IR701 Fallopian tube Appendix
Calcitonin Polyclonal GA515 IR515 Thyroid NA C
Caldesmon h-CD GA054 IR054 Colon/Appendix Breast or
breast hyperplasia
Calretinin DAK-Calret 1 IR627 Colon/Appendix NA A
Carcinoembryonic Antigen II-7 GA622 IR622 Colon/Appendix Tonsil A
CD1a 010 IR069 Tonsil Thymus B
CD2 AB75 GA651 IR651 Tonsil Colon/Appendix A
CD3 Polyclonal GA503 IR503 Tonsil Colon A
CD4 4B12 IR649 Tonsil Liver A
CD5 4C7 IR082 Tonsil NA A
CD7 CBC.37 GA643 IR643 Tonsil Colon/Appendix A
CD8 C8/144B GA623 IR623 Tonsil NA A
CD10 56C6 GA648 IR648 Liver Tonsil A
CD15 Carb-3 GA062 IR062 Tonsil Kidney B
CD19 LE-CD19 GA656 IR656 Tonsil Colon/Appendix A
CD20cy L26 GA604 IR604 Tonsil Liver A
CD21 1F8 IR608 Tonsil NA A
CD23 DAK-CD23 GA781 IR781 Tonsil NA A
CD30 Ber-H2 GA602 IR602 Tonsil NA A
CD31, Endothelial Cell JA70A GA610 IR610 Colon/Appendix Tonsil A
CD34, Class II QBEnd 10 GA632 IR632 Liver Colon/Appendix A
CD43 DF-T1 GA636 IR636 Tonsil Colon/Appendix A
CD45, Leucocyte Common 2B11 + GA751 IR751 Tonsil Brain B
Antigen PD7/26
CD56 123C3 IR628 Colon/Appendix Tonsil A
CD57 TB01 GA647 IR647 Tonsil Colon/Appendix A
CD68 KP1 GA609 IR609 Tonsil Brain B
CD68 PG-M1 GA613 IR613 Tonsil Brain B
CD79α JCB117 GA621 IR621 Tonsil NA A
CD99, Ewing’s Sarcoma Marker 12E7 IR057 Thymus NA B
CD138 MI15 GA642 IR642 Tonsil Colon/Appendix A
CD246, ALK Protein ALK1 GA641 IR641 Anaplastic large NA
cell lymphoma
with t(2;5)
translocation
CDX-2 DAK-CDX-2 GA080 IR080 Appendix Pancreas A
Chorionic Gonadotropin Polyclonal GA508 IR508 Placenta NA C
129
Cyclin D1 EP12 GA083 IS083 Tonsil NA A
Cytokeratin AE1/AE3 GA053 IR053 Liver NA A
Cytokeratin 5/6 D5/16 B4 GA780 IS780 Tonsil Prostate B
Cytokeratin 7 OV-TL12/30 GA619 IR619 Pancreas NA A
Cytokeratin 8/18 EP17/EP30 IR094 Liver Tonsil A
Cytokeratin 17 E3 IR620 Skin Breast hyperplasia C
Cytokeratin 18 DC10 GA618 IR618 Liver NA A
Cytokeratin 19 RCK108 GA615 IR615 Liver Tonsil A
Cytokeratin 20 Ks20.8 GA777 IR777 Colon/Appendix NA A
Cytokeratin, High Molecular 34βE12 GA051 IR051 Tonsil Prostate B
Weight
Cytomegalovirus CCH2 + IR752 Cytomegalovirus NA
DDG9 infected tissue
Desmin D33 IR606 Colon/Appendix Striated muscle
E-Cadherin NCH-38 GA059 IR059 Colon/Appendix Liver A
Epithelial Antigen Ber-EP4 GA637 IR637 Colon/Appendix Kidney
Epithelial Membrane Antigen E29 GA629 IR629 Tonsil Breast
Epstein-Barr Virus, LMP CS.1-4 IR753 Burkitt EBV+ tissue
lymphoma/
leukemia (EBV+)
ERCC1 4F9 IR091 Colon/Appendix NA A
Estrogen Receptor α 1D5 IR657 Cervix NA C
Estrogen Receptor α EP1 GA084 IR084 Cervix Breast hyperplasia
Ets-Related Gene (ERG) EP111 GA659 IR659 Tonsil Colon/Appendix A
Gastrin Polyclonal GA519 IR519 Stomach NA
GCDFP-15 22A3 GA077 IR077 Breast Skin C
hyperplasia
Glial Fibrillary Acidic Protein Polyclonal GA524 IR524 Brain Colon
Helicobacter Pylori Polyclonal GA523 IR523 Gastric mucosa NA
Hepatocyte OCH1E5 GA624 IR624 Liver NA A
Herpes Simplex Virus Type 1 Polyclonal GA521 IS521 Lesion with HSV NA
IgA Polyclonal GA510 IR510 Tonsil NA A
IgD Polyclonal IR517 Tonsil NA A
IgG Polyclonal GA512 IR512 Tonsil NA A
IgM Polyclonal GA513 IR513 Tonsil NA A
Inhibin α R1 GA058 IR058 Testis Placenta
Insulin Polyclonal IR002 Pancreas NA A
Kappa Light Chains Polyclonal GA506 IR506 Tonsil NA A
Ki-67 Antigen MIB-1 GA626 IR626 Tonsil NA A
Lambda Light Chains Polyclonal GA507 IR507 Tonsil NA A
Mammaglobin 304-1A5 GA074 IR074 Skin Breast hyperplasia C
Mast Cell Tryptase AA1 IR640 Tonsil Colon A
Melan-A A103 IR633 Skin Adrenal gland
Melanosome HMB45 GA052 IR052 Nevus NA C
MUC2 CCP58 IR658 Colon/Appendix NA A
MUC5AC CLH2 IR661 Cervix Gastric
MUM1 Protein MUM1p GA644 IR644 Colon/Appendix Tonsil A
MutL Protein Homolog 1 ES05 IR079 Colon/Appendix Tonsil A
(MLH1)
MutS Protein Homolog 2 FE11 IR085 Colon/Appendix Tonsil A
(MSH2)
130
MutS Protein Homolog 6 EP49 IR086 Colon/Appendix NA A
(MSH6)
Myeloperoxidase Polyclonal GA511 IR511 Liver Tonsil A
Myogenin F5D GA067 IR067 Rhabdomyo- Leiomyosarcoma
sarcoma
Myosin Heavy Chain (Smooth SMMS-1 IR066 Appendix Uterus
Muscle)
Neurofilament Protein 2F11 GA607 IR607 Colon/Appendix NA A
Neuron-Specific Enolase BBS/NC/ IR612 Colon/Appendix Pancreas A
VI-H14
Nucleophosmin 376 GA652 IR652 Liver Brain
Octamer-Binding Transcription N1NK IR092 Seminoma NA
Factor 3/4
p53 Protein DO-7 GA616 IR616 Colon Colon/Appendix
adenocarcinoma
p63 Protein DAK-p63 GA662 IR662 Tonsil NA A
Placental Alkaline Phosphatase 8A9 IR779 Placenta NA C
Pneumocystis Jiroveci 3F6 IR635 Lung (P. jiroveci NA
infection)
Podoplanin D2-40 IR072 Appendix NA A
Postmeiotic Segregation EP51 IR087 Colon/Appendix NA A
Increased 2 (PSM2)
Progesterone Receptor PgR 636 IR068 Cervix NA C
Progesterone Receptor PgR 1294 GA090 Cervix NA C
Prostate-Specific Membrane 3E6 IR089 Prostate NA B
Antigen
Prostein 10E3 IR088 Prostate NA B
Renal Cell Carcinoma Marker SPM314 GA075 IR075 Kidney NA B
S100 Polyclonal GA504 IR504 Colon/Appendix NA A
Synaptophysin DAK-SYNAP GA660 IR660 Colon/Appendix NA A
Terminal Deoxynucleotidyl EP266 IR093 Thymus NA B
Transferase
Thyroglobulin Polyclonal GA509 IR509 Thyroid NA C
Thyroid Transcription Factor 8G7G3/1 IR056 Thyroid Lung
Tyrosinase T311 IR061 Nevus Skin C
Villin 1D2 C3 IR076 Colon/Appendix Liver A
Vimentin V9 GA630 IR630 Tonsil Liver A
Von Willebrand Factor Polyclonal GA527 IR527 Colon/Appendix Liver A
Wilms' Tumor 1 Protein 6F-H2 IR055 Fallopian tube NA
ZAP-70 2F3.2 IR653 Tonsil NA A
131
This information is subject to change without notice.
© Agilent Technologies, Inc. 2020

Published in the USA, July 27, 2020
00230 D58532_02 2020JUN23

Atlas of Controls - 1st Edition

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FLEX Ready-to-Use

Many laboratories are now participating in external quality assessment (EQA)

To obtain appropriate sensitivity and specificity in developing the FLEX

Reaction Location Cytoplasm

Quality Control Liver Tonsil

Tissue type and

Reaction Location Cytoplasm

Quality Control Colon/Appendix Tongue

Reaction Location Cytoplasm

Quality Control Colon/Appendix Liver

Reaction Location Cytoplasm

Quality Control Tonsil Liver

Reaction Location Cytoplasm

Quality Control Embryonal carcinoma

Embryonal carcinoma (20x)

Embryonal carcinoma (20x)

Reaction Location Cytoplasm

Quality Control Prostate adenocarcinoma Benign prostatic hyperplasia

Non-expression NA The epithelial cells of hyperplastic prostate glands are negative or

Prostate adenocarcinoma (20x)

Benign prostatic hyperplasia (20x)

Reaction Location Extracellular and cytoplasm

Quality Control Kidney with amyloidosis Colon with amyloidosis

Note: The antibody occasionally labels serum.

Reaction Location Nucleus

Quality Control Tonsil

Non-expression Squamous epithelial cells.

Reaction Location Cytoplasm

Quality Control Tonsil

Non-expression Germinal center B cells.

Reaction Location Nucleus

Quality Control Tonsil

Note: Approximately 10% of germinal center T cells in tonsil are labeled.

Reaction Location Membrane

Quality Control Colon/Appendix Liver

Note: A weak cytoplasmic reaction is accepted.

Reaction Location Membrane and cytoplasm

Quality Control Fallopian tube Appendix

Fallopian tube (10x)

Reaction Location Cytoplasm

Quality Control Thyroid Medullary thyroid carcinoma

Note: It is suggested to include a medullary thyroid carcinoma as control.

Medullary thyroid carcinoma (20x)

Reaction Location Cytoplasm

Quality Control Colon/Appendix Breast or breast hyperplasia

Non-expression Epithelial cells. Epithelial cells.

Reaction Location Nucleus and cytoplasm

Quality Control Colon/Appendix

Non-expression Epithelial cells.

Reaction Location Membrane and cytoplasm

Quality Control Colon/Appendix Tonsil

Reaction Location Membrane and/or cytoplasm

Quality Control Tonsil Thymus

Non-expression Epithelial cells. NA

Reaction Location Membrane and cytoplasm

Quality Control Tonsil Colon/Appendix

Reaction Location Membrane and/or cytoplasm

Quality Control Tonsil Colon/Appendix

Reaction Location Membrane

Note: A weak cytoplasmic reaction is accepted.

Note: Plasma cells may show a focal cytoplasmic staining reaction.