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Leica TA9217 - page 1
Page 1 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Leica HER2 FISH System - 30 T est Instructions For Use For use on Leica Biosystems’ BOND-MAX and BOND-III System. T A9217 is a uorescence in situ hybridization product designed to stain 30 tests (30 slides stained with LS ...
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Leica TA9217 - page 2
English Page 2 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Contents Intended Use ............................................................................................................................................................................... 3 For in vitro diagn ...
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Leica TA9217 - page 3
Page 3 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Intended Use For in vitro diagnostic use The Leica HER2 FISH System - 30 T est is designed to detect amplication of the HER2/neu gene via uorescence in situ hybridization (FISH) in formalin-xed, parafn-embe ...
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Leica TA9217 - page 4
English Page 4 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 in chromosome 17 copy number (aneusomy) are also ...
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Leica TA9217 - page 5
Page 5 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English The Leica HER2 FISH System - 30 T est is for use only on the Leica BOND-MAX and BOND-III System. Components Provided The materials listed below (T able 1) are sufcient to stain 30 tests (30 slides stained with LSI H ...
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Leica TA9217 - page 6
English Page 6 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 T issue sections mounted on charged slides (Leica BOND Plus Slides S21.21 13) can be held for up to 12 months at 2–8 °C before staining. Following sectioning, it is recommended that slides are incubated at 60 °C fo ...
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Leica TA9217 - page 7
Page 7 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English bandpass uorescence microscope lter sets optimized for use with the Leica HER2 FISH System - 30 T est are available for most microscope models. The recommended lter sets for the Leica HER2 FISH System - 30 T e ...
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Leica TA9217 - page 8
English Page 8 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 5. T urn 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 T est kit, scan the reagent tray barcode with the handheld scanner to ent ...
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Leica TA9217 - page 9
Page 9 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Signal Assessment and Enumeration T o assess the signal quality and enumerate the HER2 and CEP17 signals follow the process below: 1. Assessment of Slide Quality Evaluate slide quality using the following criteria: • ...
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Leica TA9217 - page 10
English Page 10 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Recommended Method for LSI HER2 to CEP17 Ratio Determination T o determine the LSI HER2 to CEP17 ratio, use the following method: 1. Record and determine the number of LSI HER2 and CEP17 signals in 20 nuclei (see Figu ...
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Leica TA9217 - page 11
Page 1 1 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Figure 1: Interpretation Guide Leica HER2 FISH S ystem - 30 T est Interpretation Guide Count as 2 orange signals and 1 green signal Do not count. Nuclei with no signals or with signals of only 1 color should not be s ...
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Leica TA9217 - page 12
English Page 12 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Leica HER2 FISH S ystem - 30 T est 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 13 4 14 5 15 6 16 7 17 8 18 9 19 10 20 T otal ...
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Leica TA9217 - page 13
Page 13 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 accuracy of signal enumeration. Control slides s ...
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Leica TA9217 - page 14
English Page 14 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 patterns should be interpreted in association wit ...
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Leica TA9217 - page 15
Page 15 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 between the two tests in a 2x2 analysis show a conc ...
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Leica TA9217 - page 16
English Page 16 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 between the two tests in a 2x2 analysis show a conc ...
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Leica TA9217 - page 17
Page 17 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Precision T esting – Leica BOND-MAX System A. Within Run Precision Study The within run precision study was performed in a randomized and blinded fashion. Within run precision testing of the Leica HER2 FISH System - ...
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Leica TA9217 - page 18
English Page 18 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 independently manufactured lots of the Leica HER2 FISH Syst ...
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Leica TA9217 - page 19
Page 19 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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 the Leica HER2 FISH System - 30 T est was evaluat ...
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Leica TA9217 - page 20
English Page 20 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 denaturation time is recommended. • No difference in amplication status was observed when the hybridization time was performed for 9 hours and 15 hours when compared to the default Leica HER2 FISH System - 30 T e ...
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Leica TA9217 - page 21
Page 21 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English T roubleshooting Problem Probable C ause Remedial Action No or weak uorescent signal/staining Inappropriate xation or processing of test specimen Ensure a formalin-based xativ e is used and that processing sc ...
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Leica TA9217 - page 22
English Page 22 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Problem Probable C ause Remedial Action Nonspecic background uorescent signal/staining Inadequate post hybridization washing Increase post hybridization wash incubation time. Inappropriate bulk reagents dispense ...
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Leica TA9217 - page 23
Page 23 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 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, King CR, Pierce JH, Segatto O, Aaronson SA, et ...
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Leica TA9217 - page 24
Page 24 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 License Agreement This product contains PathV ysion FISH probes supplied by Abbott Molecular Inc. PathV ysion, LSI and CEP are a trademark of Abbott Molecular Inc. All Rights Reserved. Used under License. Amendments to Previo ...
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