Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 9)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
English
34. Load the slide tray onto the BOND and press the Load/Unload button.
35. Confirm that the slides have been scanned and click the Run (Play) button on the System
status screen.
36. Ensure that the tray indicator field displays Proc (OK) and batch number and finish time
are displayed.
37. When the run is completed press the Load/Unload button and remove the slide trays from
the BOND.
38. Remove Covertiles and rinse the slides in de-ionized water.
39. Dehydrate, clear and mount sections.
Quality Control
Differences in tissue fixation, processing and embedding in the user’s laboratory may produce
significant variability in results, necessitating regular performance of in-house controls in
addition to the HER2 Control Slides supplied by Leica Biosystems in the Bond Oracle HER2
IHC System. Consult the quality control guidelines of the College of American Pathologists
(CAP) Certification Program for Immunohistochemistry; see also CLSI (formerly NCCLS)
Quality Assurance for Immunocytochemistry, Approved Guideline (12) and Special Report:
Quality Control in Immunohistochemistry (13). In addition, refer to Table 3 below for the types of
immunohistochemical quality controls and their purposes.
Sample* Description HER2 Primary Antibody
Staining
HER2 Negative
Control Staining
HER2 Control
Slide As supplied in the Bond Oracle
HER2 IHC System. Controls staining procedure,
and indicates the validity of
the reagent performance.
Detection of
nonspecific
background
staining
In-house
Positive Control
Tissue Tissue containing target
antigen. The ideal control
is weakly positive staining
tissue so as to define subtle
changes in primary antibody
sensitivity. Controls all steps of the
analysis. Validates tissue
preparation and Bond Oracle
HER2 IHC System staining
performance.
In-house
Negative
Control Tissue
Component Tissues or cells expected
to be negative (could be
located in patient tissue or
positive/negative control
tissue components). Detection of nonspecific
antibody cross-reactivity
with cells/cellular
components.
*Fixed and processed as per patient sample
Table 3. Immunohistochemical quality controls and their purpose
Control tissue should be biopsy or surgical specimens, formalin-fixed, processed and paraffin-
embedded as soon as possible, and in the same manner as the patient sample(s). Specimens
must be handled appropriately to preserve the tissue antigenicity for immunohistochemical
staining. Standard methods of tissue processing should be employed for all specimens (12).