Filter
Top Products
English
Page 2 of 24
English
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 Specic 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