Leica Biosystems HER2 FISH System - 30 Test - Manual (Page 22)

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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
Problem Probable Cause Remedial Action
Nonspecific
background
fluorescent
signal/staining Inadequate post hybridization
washing Increase post hybridization wash incubation
time.
Inappropriate bulk reagents
dispensed Ensure all Leica 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 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,
and select areas which show best fixation
patterns.
Sections adhered to slides
using alternative adhesives Use Leica BOND Plus Slides (S21.2113).
Poor preservation
of tissue
morphology Inadequate tissue fixation and
processing 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,
and select areas which show best fixation
patterns.
Inappropriate pretreatment Adjust pretreatment protocol (HIER or
Enzymatic Digestion).
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
S21.2113). Ensure slides receive adequate
draining and are incubated for 1 hour at 60 °C.
Table 6. Leica HER2 FISH System - 30 Test Troubleshooting Guide.
If any problems associated with the Leica HER2 FISH System - 30 Test fall outside the scope
of the troubleshooting guide please contact your local Leica Biosystems Technical Services
Department or Distributor for assistance.