Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 6)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
Procedure
A. Reagents required but not supplied
• BOND Dewax Solution (product code AR9222)
• BOND Epitope Retrieval Solution 1 (product code AR9961)
• BOND Wash Solution x10 Concentrate (product code AR9590)
• Standard solvents used in immunohistochemistry ( e.g. ethanol, absolute and graded)
• Xylene (or xylene substitutes)
• Mounting medium
• Distilled or de-ionized water
B. Equipment required but not supplied
• Leica Biosystems’ BOND-MAX and BOND-III fully automated, advanced staining
system(s)
• BOND Universal Covertiles
TM
(product code S21.2001 or S21.4583)
• BOND Mixing Stations (product code S21.1971)
• Drying oven, capable of maintaining 60 °C
• Light microscope (4–40x objective magnification)
• Slides (Leica BOND Plus Slides – product code S21.2113)
• Coverslips
• BOND Slide Label & Print Ribbon (product code S21.4564)
• BOND Aspirating Probe Cleaning System (product code CS9100)
C. Methodology
• Prior to undertaking this methodology, users must be trained in BOND fully automated
immunohistochemical techniques.
• Each test section to be stained with the HER2 Primary Antibody will require an identical
section for staining with the HER2 Negative Control. The negative control section allows
differentiation between specific and nonspecific staining at the antigen site. Each BOND
staining run should include a HER2 Control Slide. At the end of the staining protocol, if
the cell lines do not demonstrate the correct staining patterns (refer to Bond Oracle HER2
IHC Systems Interpretation Guide), the run should be regarded as invalid.
D. Slide Layout
A new BOND Universal Covertile (product code S21.2001 or S21.4583) should be used with
each slide. The use of BOND Universal Covertiles which have been previously utilized for
either immunohistochemical or in situ hybridization staining has not been validated with this
test.
The slide tray layout (Table 2) enables optimal performance of the Bond Oracle HER2 IHC
System and the full 60 tests to be obtained.