Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 11)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
English
and/or CLSI (formerly NCCLS) Quality Assurance for Immunocytochemistry, Approved
Guideline (12). These quality control procedures should be repeated for each new antibody lot,
or whenever there is a change in assay parameters. Human invasive (infiltrating) ductal breast
carcinoma with known HER2 oncoprotein staining intensities from 0 to 3+ and other suitably
negative tissues are appropriate for assay verification.
Interpretation of Staining
For the determination of HER2 oncoprotein expression, only membrane staining pattern and
intensity should be evaluated using the scale presented in Table 4. A pathologist using a bright-
field microscope should perform slide evaluation. For evaluation of the immunohistochemical
staining and scoring, an objective of 10x magnification is appropriate. The use of 20–40x
objective magnification should be used in the confirmation of the score. Cytoplasmic staining
should be considered as nonspecific staining and is not to be included in the assessment of
membrane staining intensity (14). To aid in the differentiation of 0, 1+, 2+, and 3+ staining, refer
to the Bond Oracle HER2 IHC System Interpretation Guide for representative images of the
staining intensities. Only specimens from patients with invasive breast carcinoma should be
scored. In cases with carcinoma in situ and invasive carcinoma in the same specimen, only the
invasive component should be scored.
Immunohistochemical Staining Pattern Score Assessment
No staining is observed or membrane staining is observed in less
than 10% of the tumor cells.
0 Negative
Faint/barely perceptible membrane staining is detected in more
than 10% of the tumor cells. The cells are only stained in part of
their membrane.
1+ Negative
Weak to moderate complete membrane staining is observed in
more than 10% of the tumor cells.
2+
Equivocal
(Weakly Positive)
Strong complete membrane staining is observed in more than
10% of the tumor cells.
3+ Strongly Positive
Table 4. Interpretation of HER2 staining
Bond Oracle HER2 IHC System staining results are interpreted as negative for HER2
oncoprotein expression with scores of 0 and 1+ staining intensity, equivocal (weakly positive)
with a score of 2+ staining intensity, and strongly positive with a score of 3+ staining intensity.
Bond Oracle HER2 IHC System is not intended to provide prognostic information to the patient
and/or physician and has not been validated for that purpose. For each staining assessment,
slides should be examined in the order presented below to determine the validity of the staining
run and enable semi-quantitative assessment of the staining intensity of the sample tissue.