Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 2)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
Contents
Intended Use .............................................................................................................................3
Summary and Explanation ......................................................................................................3
Background ..........................................................................................................................................3
Expression of HER2 .............................................................................................................................3
Clinical Concordance Summary ...........................................................................................................3
Principle of Procedure .............................................................................................................4
Components Provided ..........................................................................................................................4
Directions on Use .................................................................................................................................5
Storage and Stability ............................................................................................................................5
Specimen Preparation ..........................................................................................................................5
Warnings and Precautions ...................................................................................................................5
Procedure ..................................................................................................................................6
A. Reagents required but not supplied .................................................................................................6
B. Equipment required but not supplied ...............................................................................................6
C. Methodology ....................................................................................................................................6
D. Slide Layout .....................................................................................................................................6
E. Procedure Steps ..............................................................................................................................7
Quality Control ..........................................................................................................................9
HER2 Control Slide – HER2 Primary Antibody ..................................................................................10
In-house Positive Control Tissue – HER2 Primary Antibody ..............................................................10
In-house Negative Control Tissue Component – HER2 Primary Antibody .........................................10
Patient Tissue – HER2 Negative Control ..........................................................................................10
Patient Tissue – HER2 Primary Antibody ..........................................................................................10
Assay Verification ..............................................................................................................................10
Interpretation of Staining .................................................................................................................... 11
Slide Screening Order Rationale ..........................................................................................12
1. HER2 Control Slide – HER2 Primary Antibody .............................................................................. 11
2. In-house Positive Control Tissue – HER2 Primary Antibody ..........................................................12
3. In-house Negative Control Tissue Component – HER2 Positive Control .......................................12
4. Patient Tissue – stained using the HER2 Negative Control ...........................................................12
5. Patient Tissue – stained using the HER2 Primary Antibody ...........................................................12
Limitations ..............................................................................................................................12
A. General Limitations ........................................................................................................................12
B. Product Specific Limitations ...........................................................................................................13
Cell Line Data ..........................................................................................................................14
Clinical Concordance of Bond Oracle HER2 IHC System to Dako HercepTest ................14
2x2 Concordance Results ..................................................................................................................15
3x3 Concordance Results ..................................................................................................................15
Clinical Concordance of Bond Oracle HER2 IHC System to PathVysion DNA HER-2 Probe
Kit....................................................................................................................................................... 16
2x2 Concordance Results ..................................................................................................................16
Immunoreactivity – Normal Panel .........................................................................................17
Reproducibility Study ............................................................................................................18
Within and Between Precision Testing ...............................................................................................18
A. Within Run Precision Testing .........................................................................................................18
B. Between Run Precision Testing .....................................................................................................18
C. Lot-to-Lot Reproducibility ...............................................................................................................18
D. Between Laboratory Reproducibility ..............................................................................................19
E. Inter-Observer Reproducibility .......................................................................................................19
F. Between Instrument Precision (BOND-MAX vs BOND-III)..............................................................20
Troubleshooting .....................................................................................................................21
References ..............................................................................................................................22