Troubleshooting – Leica Biosystems Bond Oracle HER2 IHC System User Manual

Page 21

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Page 21 of 23

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013

English

Troubleshooting

Problem

Probable Cause

Remedial Action

No immunohistochemical
staining

Run aborted prior to
completion

Using BOND software, confirm the presence of
any reportable errors during the staining run and
address as instructed by the BOND software.

Incorrect protocol selection

Ensure appropriate default to *IHC Protocol H

in

the staining protocol field of the Add slide dialog.

Inadequate
deparaffinization of slides

Ensure *Dewax mode is selected in the
Preparation field of the Add slide dialog.

Inappropriate bulk reagents
dispensed

Ensure all BOND reagents have been allocated
to appropriate bulk containers and placed into
appropriate positions on the instrument.

Contamination of BOND Wash
Solution with sodium azide

Use fresh BOND Wash Solution prepared to
appropriate working strength.

Weak specific
immunohistochemical
staining

Inappropriate epitope
retrieval

Ensure appropriate BOND Epitope Retrieval reagents
have been allocated into correct bulk containers, and
BOND software has defaulted to the appropriate
epitope retrieval protocol,
*HIER 25 min with *ER1 (97).

Inappropriate fixation
or processing of test
specimen

Ensure a formalin-based fixative is used and
that processing schedules are suitable for the
specimen undergoing testing.

Bond Oracle HER2 IHC System
is being used outside its expiry
date

Ensure the Bond Oracle HER2 IHC System used is
within its specified expiry date.

Excessive specific
immunohistochemical
staining

Inappropriate epitope
retrieval

Ensure appropriate BOND Epitope Retrieval
reagents have been allocated into appropriate bulk
containers, and the BOND software has defaulted
to *HIER 25 min with ER1 (97).

Variation in fixation

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 the areas which show best fixation

patterns in conjunction with a corresponding

H&E stained section.

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