Leica Biosystems HER2 FISH System - 30 Test - Manual (Page 2)

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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
Contents
Intended Use ...............................................................................................................................................................................3
For in vitro diagnostic use .............................................................................................................................................................................. 3
Required training ............................................................................................................................................................................................ 3
Summary and Explanation ........................................................................................................................................................3
Background .................................................................................................................................................................................................... 3
Clinical Concordance Summary Leica BOND-MAX System .......................................................................................................................... 4
Clinical Concordance Summary Leica BOND-III System ............................................................................................................................... 4
Principle of Procedure .................................................................................................................................................................................... 4
Components Provided .................................................................................................................................................................................... 5
Directions For Use .......................................................................................................................................................................................... 5
Storage and Stability ...................................................................................................................................................................................... 5
Specimen Preparation .................................................................................................................................................................................... 5
Warnings and Precautions ............................................................................................................................................................................. 6
Procedure ....................................................................................................................................................................................6
A. Reagents required but not supplied ........................................................................................................................................................... 6
B. Equipment required but not supplied ......................................................................................................................................................... 6
C. Methodology .............................................................................................................................................................................................. 7
D. Bond Enzyme Pretreatment ....................................................................................................................................................................... 7
E. Default Staining Protocol ........................................................................................................................................................................... 7
F. Procedure Steps ........................................................................................................................................................................................ 7
G. Slide Storage .............................................................................................................................................................................................8
Signal Assessment and Enumeration ......................................................................................................................................9
Recommended Method for LSI HER2 to CEP17 Ratio Determination ......................................................................................................... 10
Leica HER2 FISH System - 30 Test Interpretation Guide ......................................................................................................11
Sample Score Sheet .................................................................................................................................................................12
Quality Control ..........................................................................................................................................................................13
Limitations ................................................................................................................................................................................13
A. General Limitations .................................................................................................................................................................................. 13
B. Product Specific Limitations ..................................................................................................................................................................... 14
Clinical Concordance of Leica HER2 FISH System - 30 Test to Abbott Molecular PathVysion HER-2 DNA Probe Kit ...14
2x2 Concordance Results Leica BOND-MAX System ................................................................................................................................. 15
2x2 Concordance Results Leica BOND-III System ...................................................................................................................................... 16
Precision Testing – Leica BOND-MAX System ......................................................................................................................17
A. Within Run Precision Study ..................................................................................................................................................................... 17
B. Within Instrument Precision Study ........................................................................................................................................................... 17
C. Between Run Precision Study ................................................................................................................................................................. 17
D. Between Laboratory Precision Study ....................................................................................................................................................... 17
E. Between Observer Precision Study ......................................................................................................................................................... 17
F. Lot-to-Lot Precision Study ....................................................................................................................................................................... 18
Precision Testing – Leica BOND-III System ...........................................................................................................................18
G. Within Run Precision Study .....................................................................................................................................................................18
H. Within Instrument Precision Study ........................................................................................................................................................... 18
I. Between Run Precision Study ................................................................................................................................................................. 18
J. Between Laboratory Precision Study ....................................................................................................................................................... 18
K. Between Observer Precision Study ......................................................................................................................................................... 19
L. Lot-to-Lot Precision Study ....................................................................................................................................................................... 19
Assay Robustness ...................................................................................................................................................................19
Troubleshooting .......................................................................................................................................................................21
References ................................................................................................................................................................................23
License Agreement ..................................................................................................................................................................24