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Manual Leica TA9217

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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 ...

  • 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 ...

  • 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 amplication of the HER2/neu gene via uorescence in situ hybridization (FISH) in formalin-xed, parafn-embe ...

  • 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 ...

  • 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 sufcient to stain 30 tests (30 slides stained with LSI H ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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: • ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 - ...

  • 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 ...

  • 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 ...

  • 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 amplication 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 ...

  • 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 ...

  • 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 Nonspecic background uorescent signal/staining Inadequate post hybridization washing Increase post hybridization wash incubation time. Inappropriate bulk reagents dispense ...

  • 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 ...

  • 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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Documents that we receive from a manufacturer of a Leica TA9217 can be divided into several groups. They are, among others:
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All of them are important, but the most important information from the point of view of use of the device are in the user manual Leica TA9217.

A group of documents referred to as user manuals is also divided into more specific types, such as: Installation manuals Leica TA9217, service manual, brief instructions and user manuals Leica TA9217. Depending on your needs, you should look for the document you need. In our website you can view the most popular manual of the product Leica TA9217.

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A complete manual for the device Leica TA9217, how should it look like?
A manual, also referred to as a user manual, or simply "instructions" is a technical document designed to assist in the use Leica TA9217 by users. Manuals are usually written by a technical writer, but in a language understandable to all users of Leica TA9217.

A complete Leica manual, should contain several basic components. Some of them are less important, such as: cover / title page or copyright page. However, the remaining part should provide us with information that is important from the point of view of the user.

1. Preface and tips on how to use the manual Leica TA9217 - At the beginning of each manual we should find clues about how to use the guidelines. It should include information about the location of the Contents of the Leica TA9217, FAQ or common problems, i.e. places that are most often searched by users in each manual
2. Contents - index of all tips concerning the Leica TA9217, that we can find in the current document
3. Tips how to use the basic functions of the device Leica TA9217 - which should help us in our first steps of using Leica TA9217
4. Troubleshooting - systematic sequence of activities that will help us diagnose and subsequently solve the most important problems with Leica TA9217
5. FAQ - Frequently Asked Questions
6. Contact detailsInformation about where to look for contact to the manufacturer/service of Leica TA9217 in a specific country, if it was not possible to solve the problem on our own.

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