Leica-biosystems Bond Oracle HER2 IHC System Manuel d'utilisateur

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English
Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
Bond
Oracle
HER2 IHC System
Instructions For Use
For use on Leica Biosystems’ BOND
fully automated, advanced staining system.
Product Code TA9145 is designed to stain 60 tests (150 slides):
60 test slides with HER2 Primary Antibody
60 test slides with HER2 Negative Control
15 HER2 Control Slides with HER2 Primary Antibody
15 positive in-house tissue controls with HER2 Primary Antibody
Leica Biosystems Newcastle Ltd
Balliol Business Park
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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Résumé du contenu

Page 1 - Instructions For Use

Page 1 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Bond™ Oracle™ HER2 IHC System In

Page 2 - Contents

EnglishPage 10 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013HER2 Control Slide – HER2 P

Page 3 - Summary and Explanation

Page 11 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Englishand/or CLSI (formerly NCC

Page 4 - Principle of Procedure

EnglishPage 12 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Slide Screening Order Ratio

Page 5 - Warnings and Precautions

Page 13 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishNonspecic staining, if

Page 6 - Procedure

EnglishPage 14 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Cell Line DataCell Line BON

Page 7 - E. Procedure Steps

Page 15 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013English2x2 Concordance ResultsIn

Page 8 - Page 8 of 23

EnglishPage 16 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013In conclusion, the data gen

Page 9 - Quality Control

Page 17 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishImmunoreactivity – Normal

Page 10 - Page 10 of 23

EnglishPage 18 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Reproducibility StudyWithin

Page 11 - Interpretation of Staining

Page 19 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Englishmasked and assessed in a

Page 12 - Limitations

EnglishPage 2 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013ContentsIntended Use ...

Page 13 - Page 13 of 23

EnglishPage 20 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013were blinded and randomized

Page 14 - HercepTest

Page 21 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishTroubleshootingProblem Pr

Page 15 - 2x2 Concordance Results

EnglishPage 22 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Problem Probable Cause Reme

Page 16 - DNA Probe Kit

Page 23 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013English5. Lewis GD, Figari I, F

Page 17 - Page 17 of 23

Page 3 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishIntended UseFor in vitro d

Page 18 - Reproducibility Study

EnglishPage 4 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013Principle of ProcedureThe Bo

Page 19 - Page 19 of 23

Page 5 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishDirections on UseAll reage

Page 20 - Page 20 of 23

EnglishPage 6 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013ProcedureA. Reagents require

Page 21 - Troubleshooting

Page 7 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013EnglishSlide PositionSlide Descri

Page 22 - References

EnglishPage 8 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/20139. Enter details for the

Page 23 - Symbol Identication

Page 9 of 23EnglishLeica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013English34. Load the slide tray on

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