Leica HER2 FISH System - 30 Test- User Manual
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Table of Contents:
- Page 2 – Contents
- Page 3 – Intended Use; diagnostic use; gene via fluorescence; Required training; Summary and Explanation; Background; in vitro
- Page 4 – Clinical Concordance Summary Leica BOND-MAX System; in situ
- Page 5 – Leica BOND Enzyme; Contains Enzyme Diluent.; Directions For Use
- 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,
- 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 8 – 990 μL of Leica BOND Enzyme Diluent.
- Page 9 – Signal Assessment and Enumeration
- 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:
- Page 11 – Leica HER2 FISH System - 30 Test Interpretation Guide
- Page 12 – Leica HER2 FISH System - 30 Test Score Sheet; 0 Nuclei Signal Count
- Page 13 – Quality Control; Use of Control Slides; section. The criteria for slide quality must be satisfied; Limitations; A. General Limitations
- 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.
- Page 15 – PathVysion
- Page 16 – Abbott Molecular PathVysion HER-2 DNA Probe Kit
- 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 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
- Page 19 – Assay Robustness; temperature and humidity.
- Page 20 – denaturation time is recommended.
- Page 21 – Troubleshooting
- Page 22 – Problem; Department or Distributor for assistance.
- Page 23 – References; fluorescence in situ hybridization.
- Page 24 – Symbol Identification; Batch Code; Catalog number; Manufacturer; SN; Serial Number
Page 1 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
Instructions For Use
For use on Leica Biosystems’ BOND-MAX and BOND-III System.
TA9217 is a fluorescence
in situ
hybridization product designed to stain 30 tests (30 slides
stained with LSI HER2/CEP17 Dual Probe).
Leica Biosystems Newcastle Ltd
Balliol Business Park West
Benton Lane
Newcastle Upon Tyne NE12 8EW
United Kingdom
(
+44 191 215 4242
Leica Biosystems Canada
71 Four Valley Drive
Concord, Ontario L4K 4V8
Canada
(
+1 800 248 0123
Leica Biosystems Inc
1700 Leider Lane
Buffalo Grove IL 60089
USA
(
+1 800 248 0123
Leica Biosystems Melbourne
Pty Ltd
495 Blackburn Road
Mt Waverly VIC 3149
Australia
(
+61 2 8870 3500
IVD
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Summary
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 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...
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...
