Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 5)

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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
English
Directions on Use
All reagents supplied are formulated specifically for use with this assay and lot numbers are
specific for each Bond Oracle HER2 IHC System. For the assay to be valid, no substitutions
should be made.
Storage and Stability
Store at 2–8 °C. Do not freeze. Return to 2–8 °C immediately after use. Any deviation from these
conditions will invalidate the assay. Ensure the Bond Oracle HER2 IHC System used is within its
designated expiry date. The signs indicating contamination and/or instability of the Bond Oracle
HER2 IHC System are: turbidity of the solutions, odor development, and presence of precipitate.
Storage conditions other than those specified above must be verified by the user.
Specimen Preparation
All specimens must be prepared to preserve the tissue for immunohistochemical staining.
Standard methods of tissue processing should be used for all specimens (12).
It is recommended that tissues are prepared in formalin-based fixatives and are routinely
processed and paraffin-embedded. For example, resection specimens should be blocked into
a thickness of 3–4 mm and fixed for 18–24 hours in 10% neutral-buffered formalin. The tissues
should then be dehydrated in a series of alcohols and cleared through xylene, followed by
impregnation with molten paraffin wax, held at no more than 60 °C. Tissue specimens should
be sectioned between 3–5 µm.
The slides required for HER2 oncoprotein evaluation and tumor verification should be prepared
at the same time. To preserve antigenicity, tissue sections mounted on slides (Leica BOND
Plus Slides – product code S21.2113) should be stained within 4–6 weeks of sectioning when
held at room temperature (20–25 °C). Following sectioning, it is recommended that slides are
incubated for 12–18 hours (overnight) at 37 °C. Sections which require additional adherence
may be incubated at 60 °C for a further hour.
In the USA, the Clinical Laboratory Improvement Act of 1988 requires in 42 CFR 493.1259(b)
that “The laboratory must retain stained slides for at least ten years from the date of examination
and retain specimen blocks at least two years from the date of examination”.
Warnings and Precautions
For professional users only.
One or more components in the product are hazardous.
As a rule, persons under 18 years of age are not allowed to work with this product. Users must
be carefully instructed in the proper work procedure, the hazardous properties of the product
and the necessary safety instructions.
Symptoms of overexposure to ProClin
™
950, the preservative used in the Oracle reagents, may
include skin and eye irritation and irritation to mucous membranes and upper respiratory tract.
The concentration of ProClin
™
950 in this product is up to a maximum of 0.35%. These solutions
do not meet the OSHA criteria for a hazardous substance. A Material Safety Data Sheet is
available upon request or from www.LeicaBiosystems.com.
Specimens, before and after fixation, and all materials exposed to them, should be handled as
if capable of transmitting infection and disposed of with proper precautions.
Never pipette reagents by mouth and avoid contacting the skin and mucous membranes with
reagents and specimens. If reagents or specimens come into contact with sensitive areas, wash
with copious amounts of water. Seek medical advice. Consult federal, state or local regulations
for disposal of any potentially toxic components.
Minimize microbial contamination of reagents or an increase in nonspecific staining may occur.