Leica HER2 FISH System - 30 Test- Manuals

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User Manual

User Manual Leica HER2 FISH System - 30 Test

Summary

Page 2 - Contents

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 .......................................................................................................................................................

Page 3 - Intended Use; diagnostic use; gene via fluorescence; Required training; Summary and Explanation; Background; in vitro

Page 3 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Intended Use For in vitro diagnostic use The Leica HER2 FISH System - 30 Test is designed to detect amplification of the HER2/neu gene via fluorescence in situ hybridizat...

Page 4 - Clinical Concordance Summary Leica BOND-MAX System; in situ

English Page 4 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 The characteristic morphology of the tissue and the spatial distribution of oncogene copies in individual uncultured primary breast carcinomas are retained. Aberrations i...

Page 5 - Leica BOND Enzyme; Contains Enzyme Diluent.; Directions For Use

Page 5 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English The Leica HER2 FISH System - 30 Test is for use only on the Leica BOND-MAX and BOND-III System. Components Provided The materials listed below (Table 1) are sufficient to...

Page 6 - Warnings and Precautions; For professional users only.; Procedure; A. Reagents required but not supplied; • Standard solvents used in fluorescence; B. Equipment required but not supplied; – Excitation Peak at 559nm,

English Page 6 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 Tissue sections mounted on charged slides (Leica BOND Plus Slides S21.2113) can be held for up to 12 months at 2–8 °C before staining. Following sectioning, it is recomme...

Page 7 - automated; D. BOND Enzyme Pretreatment; and that a minimum volume of 900 μL be used per run.; E. Default Staining Protocol; recommended default staining protocol shown in Table 2 below.; Protocol Type; immunohistochemical or

Page 7 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English bandpass fluorescence microscope filter sets optimized for use with the Leica HER2 FISH System - 30 Test are available for most microscope models. The recommended filter ...

Page 8 - 990 μL of Leica BOND Enzyme Diluent.

English Page 8 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 5. Turn on the PC attached to the Leica BOND-MAX and BOND-III System. 6. Open the Leica BOND software. 7. For a new Leica HER2 FISH System - 30 Test kit, scan the reagent...

Page 9 - Signal Assessment and Enumeration

Page 9 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Signal Assessment and Enumeration To assess the signal quality and enumerate the HER2 and CEP17 signals follow the process below: 1. Assessment of Slide Quality Evaluate ...

Page 10 - Recommended Method for LSI HER2 to CEP17 Ratio Determination; To determine the LSI HER2 to CEP17 ratio, use the following method:; additional 20 nuclei and recalculate the ratio.; Results should be reported as follows:

English Page 10 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 Recommended Method for LSI HER2 to CEP17 Ratio Determination To determine the LSI HER2 to CEP17 ratio, use the following method: 1. Record and determine the number of LS...

Page 11 - Leica HER2 FISH System - 30 Test Interpretation Guide

Page 11 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Figure 1: Interpretation Guide Leica HER2 FISH System - 30 Test Interpretation Guide Count as 2 orange signals and 1 green signal Do not count. Nuclei with no signals or...

Page 12 - Leica HER2 FISH System - 30 Test Score Sheet; 0 Nuclei Signal Count

English Page 12 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 Leica HER2 FISH System - 30 Test Score Sheet 20 Nuclei Signal Count Nucleus # HER2 Copy Number CEP17 Copy Number Nucleus # HER2 Copy Number CEP17 Copy Number 1 11 2 12 3...

Page 13 - Quality Control; Use of Control Slides; section. The criteria for slide quality must be satisfied; Limitations; A. General Limitations

Page 13 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Quality Control Use of Control Slides It is recommended that a Leica HER2 FISH Control Slide is included in each test run to monitor assay performance and to assess the ...

Page 14 - a qualified pathologist.; B. Product Specific Limitations; use of any other type of fixative may invalidate the assay.; Clinical Concordance of HER2 FISH System - 30 Test to Abbott; negative staining agreement.

English Page 14 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 Unexpected FISH staining, or variations in the staining, may be a result of alterations in the expression levels of the encoding genes. Any change in expected staining p...

Page 15 - PathVysion

Page 15 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English 2x2 Concordance Results Leica BOND-MAX System Data was grouped as negative (<2.00) or positive (≥2.00) for a 2x2 analysis The observed agreement for 300 samples betwe...

Page 16 - Abbott Molecular PathVysion HER-2 DNA Probe Kit

English Page 16 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 2x2 Concordance Results Leica BOND-III System Data was grouped as negative (<2.00) or positive (≥2.00) for a 2x2 analysis The observed agreement for 300 samples betwe...

Page 17 - Precision Testing – Leica BOND-MAX System; A. Within Run Precision Study; expression within a single run on a single instrument.; B. Within Instrument Precision Study

Page 17 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Precision Testing – Leica BOND-MAX System A. Within Run Precision Study The within run precision study was performed in a randomized and blinded fashion. Within run prec...

Page 18 - range of HER2 expression to be tested between lots.; Precision Testing – Leica BOND-III System; G. Within Run Precision Study; H. Within Instrument Precision Study

English Page 18 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 F. Lot-to-Lot Precision Study The lot-to-lot precision study was performed in a randomized and blinded fashion. Lot-to-Lot precision was determined on three independentl...

Page 19 - Assay Robustness; temperature and humidity.

Page 19 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English K. Between Observer Precision Study The between observer precision study was performed in a randomized and blinded fashion. Between observer reproducibility testing of t...

Page 20 - denaturation time is recommended.

English Page 20 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 denaturation time is recommended. • No difference in amplification status was observed when the hybridization time was performed for 9 hours and 15 hours when compared t...

Page 21 - Troubleshooting

Page 21 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English Troubleshooting Problem Probable Cause Remedial Action No or weak fluorescent signal/staining Inappropriate fixation or processing of test specimen Ensure a formalin-bas...

Page 22 - Problem; Department or Distributor for assistance.

English Page 22 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 Problem Probable Cause Remedial Action Nonspecific background fluorescent signal/staining Inadequate post hybridization washing Increase post hybridization wash incubati...

Page 23 - References; fluorescence in situ hybridization.

Page 23 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 English References 1. Bargmann CI, Hung MC, Weinberg RA. The neu oncogene encodes an epidermal growth factor related protein. Nature 1986;319:226–30. 2. Lonardo F, Di Marco E, K...

Page 24 - Symbol Identification; Batch Code; Catalog number; Manufacturer; SN; Serial Number

Page 24 of 24 English Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013 License Agreement This product contains PathVysion FISH probes supplied by Abbott Molecular Inc. PathVysion, LSI and CEP are a trademark of Abbott Molecular Inc. All Rights Rese...