MATERIALS AND METHODS
Reagents Provided
Symphony鈩? Clear reagent is provided in a 2L Bottle Configuration. Symphony鈩? Clear
Symphony鈩? Clear reagent is a Limonene solution with addition of BHT (Butylated Hydroxytoluene).
Catalog number 900-209
Reconstitution, Mixing, Dilution, Titration
No reconstitution, mixing, dilution or titration is required. Further dilution of any of the
reagents may result in unsatisfactory staining quality. The user must validate any such
INDICATIONS AND USE
change.
Intended Use
This reagent is intended for in vitro diagnostic (IVD) use.
Materials and Reagents Needed But Not Provided
Ventana Medical Systems' (Ventana) Symphony鈩? H&E Solutions are intended for use as a 1. Reagent grade alcohol (95% SDA Formula 3A and 5% isopropyl alcohol)
qualitative histologic stain to demonstrate nuclear and cytoplasmic staining of fixed tissue anhydrous, Denatured alcohol (ethyl alcohol)
components in paraffin embedded tissue. The Symphony鈩? Clear reagent is a d-Limonene. 2. Ventana Symphony鈩? automated slide stainer
Symphony鈩? Clear is used in the deparaffinization process and clearing steps onboard the 3. Symphony鈩? B P/N 900-204
Symphony鈩? staining system. The clinical interpretation of any staining, or the absence of 4. Symphony鈩? C P/N 900-202
staining, must be complemented by morphological studies and evaluation of proper 5. Symphony鈩? D P/N 900-210
controls. The clinical interpretation of any staining must be made by a qualified pathologist6. Symphony鈩? N1 P/N 900-201
within the context of the patient鈥檚 clinical history and other diagnostic tests. 7. Symphony鈩? N2 P/N 900-205
8. Symphony鈩? W P/N 900-203
9. Symphony鈩? E P/N 900-212
Summary and Explanation
Symphony鈩? H&E Solutions include the biologic stains and ancillary solutions for H&E 10. Symphony鈩? OptiSure鈩? Coverslip P/N 900-501
(Hematoxylin and Eosin) staining. Only those dyes certified by the Biological Stain 11. Glass Microscope Slides
Commission are used in manufacturing. Each lot of stain is subjected to a series of 12. Type II or Type III Deionized water
quantitative and qualitative tests to ensure stability and lot to lot consistency. Symphony鈩?
Clear (Limonene) is used to deparaffinize slides prior to staining. The Symphony鈩? Clear Storage and Handling
(d-Limonene) is an organic solvent and is the major component of the oil extracted from Symphony鈩? Clear reagent must be stored at ambient conditions (20-28 潞C). See label for
citrus rind. After the staining is completed the slides are cleared in Symphony鈩? Clear proper storage conditions. When properly stored, Symphony鈩? Clear is stable until the
(Limonene), and coverslipped. expiration date that is printed on the package label. The user must honor the printed
expiration dates.
Principles and Procedures
Symphony鈩? H&E Solutions are optimized for use on the Ventana Symphony鈩? System (an WARNING AND PRECAUTIONS
automated high volume slide stainer). The Symphony鈩? solutions are applied directly to 1. The reagents have been optimized for use on Symphony鈩? automated slide stainer.
tissue on microscope slides. The staining reaction is based on nuclear and cytoplasmic These reagents may not be optimal for manual procedures or for use on other
staining. Symphony鈩? H&E Solutions include all the reagents for paraffin removal, staining instruments. Further dilution of reagents may result in inadequate staining. The user
and clearing of paraffin embedded tissue sections. must validate any change made to the reagent.
2. Differences in tissue processing, fixation types, and technical procedures may
Symphony鈩? Staining System Process: produce significant variability of results necessitating regular performance of
controls.1,2
Slides are loaded onto the Universal Slide Tray and placed in the instrument Entry Portal. 3. Normal precautions should be observed when handling laboratory reagents. Do not
The customer selects the appropriate staining procedure and initiates the run using the smoke, eat or drink in areas where specimens or reagents are being handled. Never
Touchscreen Interface. Three selections are available for nuclear staining intensity and pipette by mouth.
cytoplasmic staining intensity. The nuclear staining intensity selections include standard, 4. Disposal of liquid waste resulting from the use of these reagents should be
dark, and darkest. The cytoplasmic staining intensity selections include standard, lighter, performed in accordance with all local, state and federal laws.
and lightest. On the Symphony鈩? staining system, slides are scanned to determine position 5. Patient specimens and all materials contacting them should be handled as if
in the Universal Slide Tray. Slides are baked in the Slide Drying Module for tissue capable of transmitting infection. Use universal precautions when handling and
adherence. Following the baking step, slides are moved to the Staining Module for disposing of specimens.
deparaffinization, staining, and clearing. Deparaffinization utilizes the Symphony鈩? Clear 6. Avoid microbial contamination of reagents. Contamination could produce erroneous
reagent which is followed by an alcohol rinse to remove excess reagent. Following results.
deparaffinization, the steps for the standard nuclear and cytoplasmic staining intensity 7. These reagents may cause irritation. Avoid contact with eyes and mucous
protocol are listed below: membranes. If reagent contacts these areas, rinse with copious amounts of water.
8. Consult local or state authorities with regard to recommended method of disposal.
1. The Symphony鈩? W is applied to the slide.
2. The Symphony鈩? N1 reagent is applied followed by an incubation period. LIMITATIONS
3. The slides are rinsed with the Symphony鈩? W solution. General Limitations
4. Symphony鈩? B reagent is applied to the slides and incubated. 1. Histological staining is a multiple step diagnostic process that requires specialized
5. The slides are rinsed with the Symphony鈩? W solution. training in the selection of the appropriate reagents, tissue selections, fixation,
6. Gradient alcohol is deposited on the slides. processing, preparation of the slide, and interpretation of the staining results.
7. The Symphony鈩? C solution is dispensed and incubated. 2. Tissue staining is dependent on the handling and processing of the tissue prior to
8. Slides are rinsed with both gradient alcohol additions and reagent grade staining. Improper fixation, freezing, thawing, washing, drying, heating, sectioning, or
alcohol. contamination with other tissues or fluids may produce artifacts or false negative
9. The slides are cleared by the Symphony鈩? Clear reagent and transported to results.
the Slide Prep Module for the final dehydration step. 3. The clinical interpretation of any positive staining, or its absence, must be evaluated
10. Slides are moved to the Optisure鈩? Coverslip Module. within the context of clinical history, morphology and other histopathological criteria.
11. A combination of the Symphony鈩? Clear and Symphony鈩? E solutions are The clinical interpretation of any staining, or its absence, must be complemented by
deposited on the slide prior to the Optisure鈩? Coverslips for optical clarity. morphological studies and proper controls as well as other diagnostic tests. It is the
12. The slides are transported to the Slide Curing Module to secure the coverslips. responsibility of a qualified pathologist to be familiar with the Hematoxylin and Eosin
13. Finally, the Universal Slide Tray is placed in the IntelliQue鈩? for a cooling stain and methods used to produce the slide. Staining must be performed in a
period and subsequent tray ejection. certified licensed laboratory under the supervision of a pathologist who is responsible
for reviewing the stained slides and assuring the adequacy of positive and negative
controls.
4. Ventana provides stains and reagents at optimal dilution for use when the provided
instructions are followed. Any deviation from recommended test procedures may
invalidate expected results. Appropriate controls must be employed and documented.
Users who deviate from recommended test procedures must accept responsibility for
interpretation of patient results.
2006-03-31 Page 1 of 2 14385EN Rev A
Hazard Classification
Symphony鈩? Clear 900-209 NFPA Rating - Health 1, Flammability 2, Reactivity 0
REFERENCES
1.Luna LG. Histopathologic Methods and Color Atlas of Special Stains and Tissue Artifacts.
American Histolabs, Inc., Gaitheresburg, MD, 1992, p 71-72, 77.
2.Titford ME., Horenstein MG. Histomorphological Assessment of Formalin Substitute
Fixatives for Diagnostic Surgical Pathology. Archives of Pathology and Laboratory
Medicine 129: 502-506, 2005.
INTELLECTUAL PROPERTY
Ventana庐 is a registered trademark of Ventana Medical Systems, Inc.
Symphony鈩? is a trademark of Ventana Medical Systems, Inc.
OptiSureTM is a trademark of Ventana Medical Systems, Inc.
IntelliQueTM is a trademark of Ventana Medical Systems, Inc.
US and foreign patent applications pending.
CONTACT INFORMATION
North America
Ventana Medical Systems, Inc.
1910 Innovation Park Drive
Tucson, Arizona 85755
U.S.A.
800 227 2155 (U.S. only)
520 887 2155
Europe
Ventana Medical Systems, S.A.
Parc d鈥橧nnovation 鈥? BP 30 144
Rue G. de Kaysersberg
F - 67404 Illkirch Cedex
France
33 (0) 3 90 40 52 00
EU Representative
MDCI Ltd.
Arundel House
1 Liverpool Gardens
Worthing
West Sussex BN11 1SL
UK
Japan
Ventana Japan K.K.
Landmark Tower, 35F
2-2-1, Minatomirai, Nishi-ku
Yokohama, 220-8135
Japan
81 (0) 45-228-5071
Australia, New Zealand
Ventana Medical Systems, Pty Ltd
5/39 Grand Boulevard
Montmorency VIC 3094
Australia
61 (0) 3 9431 6064
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