Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 22)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
Problem Probable Cause Remedial Action
Nonspecific background
staining Inappropriate bulk reagents
dispensed Ensure all BOND reagents have been allocated
into appropriate bulk containers and placed into
appropriate positions on the instrument.
Inadequate deparaffinization
of slides Ensure *Dewax is selected in the Preparation field
of the Add slide dialog.
Nonspecific
immunohistochemical
cross-reaction in tissue Refer to Bond Oracle HER2 IHC System description
of normal tissue cross reactivity (refer to Table 9).
Nonspecific
immunohistochemical
cross-reaction with areas
of tissue necrosis Ensure a formalin-based fixative is used and
that processing schedules are suitable for the
specimen undergoing testing. If possible, retest
case using another block. If this is not possible,
assess in conjunction with a corresponding
H&E stained section, areas which show best
fixation patterns.
Drying artifact following
completion of a staining run If slides are to be placed on an overnight run it
is recommended that the BOND delayed start
functionality is used. Ensure that there is an
adequate volume of distilled or de-ionized water
available to dispense on the slides for this period
to ensure the slides do not dry out.
Sections adhered to slides
with the aid of starch
additives Use unstarched slides (e.g. Leica BOND Plus
Slides – product code S21.2113).
Tissue detached from
patient/control slide(s) Use of incorrect type
of slides or inadequate
draining of section Ensure appropriate slides are used for
patient/control sections (e.g. Leica BOND
Plus Slides – product code S21.2113).
Ensure slides receive adequate draining
and are incubated at 12–18 hours at 37 °C
(overnight). Sections which need further
adherence may be incubated at 60 °C for a
further hour.
Table 12. Bond Oracle HER2 IHC System Trouble Shooting Guide.
If any problems associated with the Bond Oracle HER2 IHC System fall outside the scope of the
troubleshooting guide (refer to Table 12) please contact your local Leica Biosystems’ Technical
Services Department or Distributor for assistance.
References
1. Corbett IP, Henry JA, Angus B et al. NCL-CB11, A new monoclonal antibody recognizing the internal
domain of the c-erbB-2 oncogene protein effective for use on formalin-fixed, paraffin-embedded
tissue. Journal of Pathology. 1990; 161:15-25.
2. Lonardo F, Di Marco E, King CR, Pierce JH, Segatto O, Aaronson SA, et al. The normal
erbB-2 product is an atypical receptor-like tyrosine kinase with constitutive activity in the absence
of ligand. New Biologist 1990; 2: 992-1003.
3. Carter P, Presta L, Gorman CM, Ridgway JBB, Henner D, Wong WLT, et al. Humanization of an
anti-p185HER2 antibody for human cancer therapy. Proceedings of the National Academy of Science
USA 1992; 89: 4285-9.
4. Hudziak RM, Lewis GD, Winget M, Fendly BM, Shepard HM, Ullrich A. p185HER2 monoclonal
antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor
necrosis factor. Molecular & Cell Biology 1989; 9: 1165-72.