Cytology Stain Kits

L012758(01)
2022‑03
English

491458 491459

INTENDED USE
The BD Cytology Stain and BD Non‑GYN stain kits are reagents (multicolored stains) used for the purpose of staining (coloring)
cells collected from the human body to be examined for diagnostic purposes.
SUMMARY AND EXPLANATION
Gynecologic and non‑gynecologic cytology involves the microscopic examination of cell samples. Visualization and differentiation
of cell types is achieved by using a cytology stain referred to as the Papanicolaou (Pap) stain. The Pap stain is designed for
transparency allowing visualization of cells that are overlapped or in groups. The Papanicolaou stain formulations may vary but
generally consist of Hematoxylin, Eosin (may contain Eosin Y, Light Green SF yellowish, and Bismarck Brown) and Orange G.
Hematoxylin stains the nucleus, Eosin (referred to as EA) and Orange G are cytoplasmic stains. Additives such as phosphotungstic
acid and lithium carbonite may be included for stability and color intensity enhancement.
Gynecologic and Non‑Gynecologic cell samples respond differently to stain uptake therefore the BD Non‑Gyn Cytology Stain kit is
designed for lower intensity staining compared to the BD Cytology Stain Kit.
The intended users are cytology laboratory personnel trained to produce a gynecologic and non‑gynecologic slides as per the
manufacturer under the direct supervision of a qualified cytology supervisor or laboratory manager/director. Qualified laboratory
professionals, Cytotechnologists and Cytopathologists, exam the stained slides for microscopic interpretation and test resulting.
LIMITATIONS OF THE PROCEDURE
• A sample that has become degraded prior to fixation will be unsatisfactory for cytologic examination.
• All supplies are intended for single use only and cannot be reused.
• Used supplies and product should be disposed of properly in accordance with institutional and governmental regulations.
WARNINGS AND PRECAUTIONS
Cytologic specimens may contain infectious agents. Wear suitable protective clothing, gloves, and eye/face protection. Follow
appropriate biohazard precautions when handling samples.

BD PrepStain™ Hematoxylin Stain, 0.75 / HEMATOXYLIN 0.5 STAIN

Contains ethanediol; ethylene glycol

Warning
H373 May cause damage to organs through prolonged or repeated exposure.
P260 Do not breathe dust/fume/gas/mist/vapors/spray.
P314 Get medical advice/attention if you feel unwell.

P501 Dispose of contents/container to an approved facility in accordance with local, regional, national and
international regulations.

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BD PrepStain™ EAOG Combo Stain
Contains Methanol

Danger
H225 Highly flammable liquid and vapor.
H302+H312+H332 Harmful if swallowed, in contact with skin or if inhaled.
H370 Causes damage to organs.
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P240 Ground and bond container and receiving equipment.
P241 Use explosion‑proof [electrical/ventilating/lighting/…] equipment.
P242 Use non‑sparking tools.
P243 Take action to prevent static discharges.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P271 Use only outdoors or in a well‑ventilated area.
P264 Wash thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P260 Do not breathe dust/fume/gas/mist/vapors/spray.
P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or
shower].
P301+P312 IF SWALLOWED: Call a POISON CENTRE/doctor/… if you feel unwell.
P330 Rinse mouth.
P307+P311 IF exposed or concerned: Call a POISON CENTER/doctor/…
P321 Specific treatment (see on this label).
P370+P378 In case of fire: Use water spray, fog, CO2, dry chemical, or alcohol resistant foam.
P312 Call a POISON CENTER/doctor if you feel unwell.
P332+P313 If skin irritation occurs: Get medical advice/attention.
P353 Rinse skin with water [or shower].
P403+P235 Store in a well‑ventilated place. Keep cool.
P405 Store locked up.
P233 Keep container tightly closed.
P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable
laws and regulations, and product characteristics at time of disposal.
Dispose of all used reagents and any other contaminated disposable materials following procedures for infectious or potentially
infectious waste. It is the responsibility of each laboratory to handle solid and liquid waste according to their nature and degree
of hazardousness and to treat and dispose of them (or have them treated and disposed of) in accordance with any applicable
regulations.
PRECAUTIONS
1. For in vitro diagnostic use. For Use by Trained Laboratory Personnel. Good laboratory practices should be followed.
2. Avoid splashing or generating aerosols. Operators should use appropriate hand, eye/face and clothing protection.
3. Do not pipette by mouth.
4. Used supplies and product should be disposed of properly in accordance with institutional and governmental regulations.
STORAGE
1. Store BD Cytology Stain Kits at room temperature (15–30 °C)
2. Do not use materials beyond the expiration date printed on the label.

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MATERIALS REQUIRED (to produce a slide)
BD Cytology Stain kits can be used with the BD PrepStain™ Slide Processor or BD Totalys™ SlidePrep Refer to the Operator’s
Manual for the BD PrepStain™ Slide Processor or BD Totalys™ SlidePrep for complete information regarding staining reagents,
components and accessories. Not all of the materials listed below are required for preparing slides.
Materials Provided Required Materials Sold Separately by BD Reagents
• 491458: BD Cytology Stain Kit contents: • BD SurePath™ Collection Vials (includes
— 1 – BD Hematoxylin Stain 0.75, 480 mL BD SurePath™ Preservative Fluid)
— 1 – BD EA/OG Combo Stain, 480 mL • BD Density Reagent
• 491459: BD Cytology NonGyn Kit contents • BD Alcohol Blend Rinse or Isopropanol and Reagent
Grade Alcohol
— 1 – BD Hematoxylin Stain 0.5, 480 mL
• BD SurePath™ Preservative Fluid
— 1 – BD EA/OG Combo Stain, 480 mL
• BD CytoRich™ Clear Collection Vial
Materials Required But Not Provided by BD
• BD CytoRich™ Clear Preservative Fluid
• Specimen Collection Container
Instruments, Equipment and Accessories
• Single Vortex Mixer
• BD Totalys™ SlidePrep and accessories
• Precision Pipettes with Disposable Tips
• BD PrepMate™ Automated Accessory
• Deionized Water (pH 7.5 to 8.5)
• BD PrepMate™ Consumables Kit
• Reagent Grade Alcohol
• BD Totalys™ MultiProcessor (alternative to
• Xylene or Xylene substitute
BD PrepMate™ Automated Accessory)
• Mounted Media
• BD CytoRich™ Red Preservative Fluid
• Coverslips
• BD CytoRich™ Blue Preservative Fluid
• BD Totalys™ MultiProcessor Consumables Kit (used
with BD Totalys™ MultiProcessor)
• Easy Aspirator Kit
• Centrifuge and accessories
• BD Settling Chambers
• BD SurePath™ PreCoat Slides
• BD Totalys™ Transfer Tips
• BD Centrifuge Tubes
• BD Syringing Pipettes
• BD Aspirator Tips
• 4 mL Density Reagent Dispenser
• Contrad 70
• Tris Buffered Saline Packet
• Cervical sampling device(s) with detachable head(s)

PROCEDURE (Processing Overview)

Automated Staining
The staining principle and process using the semi‑automated BD PrepStain™ and BD Totalys™ SlidePrep is similar for each sample
type, Gynecologic and Non‑Gynecologic. Staining begins after the cells complete the sedimentation phase in the settling chamber
and includes a sequence of washes and stain application steps using the Papanicolaou method.
Staining
1. The settling chamber is emptied and rinsed with deionized water in preparation of the water‑based hematoxylin stain.
2. BD Hematoxylin Stain applied, aspirated and re‑applied. Allowed to sit for “x” minutes.
3. The settling chamber is emptied and rinsed with BD Reagent Alcohol in preparation of the alcohol‑based EA‑OG stain.
4. BD EA/OG Combo Stain is applied, aspirated and re‑applied. Allowed to sit for “x” minutes.
5. The settling chamber is emptied and rinsed with BD Reagent Alcohol.
Finishing the slide
6. Settling chambers removed, slides rinsed with 100% alcohol, placed in clearing agent e.g. xylene and cover slipped.
Note: detailed information on processing steps to include timing, volumes etc can be found in the BD PrepStain™ and BD Totalys™
SlidePrep User’s Manuals.
Manual Staining
Staining cytology slides using the BD Cytology Stain Kit can be done using a manual batch staining method. Batch staining is
initiated by placing the prepared slides into a slide staining rack and dipping them sequentially through a series of reagents to
include the BD Cytology Stains. The reagent chemistry and step sequence are defined by the Papanicolaou staining method
protocols. The laboratory selects the Pap staining method, progressive or regressive, and supplies the washing, rinsing, and
clearing reagents to complete the task.

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REFERENCES
1. Keebler CM: Cytopreparatory Techniques. In Bibbo M (ed): Comprehensive Cytopathology, 1st ed. Philadelphia: WB Saunders,
1991, pp 881–906.
2. Keebler CM, Somrak RM: The Manual of Cytotechnology, 7th ed. Chicago: ASCP Press, 1993, 35:412–446.
3. Nayar R, Wilbur DC (eds): The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes,
ed 3. New York, Springer, 2015
4. CLSI.org. GP15A3E – Cervicovaginal Cytology Based on the Papanicolaou Technique, ISBN Number: 1‑56238‑679‑4. 2008.
Pg 16–24

Technical Service and Support: In the United States contact BD at 1.800.638.8663 or bd.com.
For regions outside of the United States, contact your local BD representative or bd.com.
EU Only: Users shall report any serious incident related to the device to the Manufacturer and National Competent Authority.
Outside EU: Contact your local BD representative for any incident or inquiry related to this device.

Change History
Revision Date Change Summary
(01) 2022‑03 Initial Release

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SYMBOLS GLOSSARY [L006715(06) 2021‑08]
Some symbols listed below may not apply to this product.
US Customers only: For symbol glossary, refer to bd.com/symbols-glossary

Symbol Meaning Symbol Meaning

Manufacturer
Patient number
Authorized representative in the European Community

Authorised representative in Switzerland This way up

Date of manufacture
Do not stack
Use‑by date
Single sterile barrier system
Batch code
Contains or presence of phthalate: combination of bis(2‑ethylhexyl) phthalate
Catalogue number (DEHP) and benzyl butyl phthalate (BBP)
Serial number Collect separately
Indicates separate collection for waste of electrical and electronic equipment
Sterile required.
Sterilized using aseptic processing techniques
CE marking; Signifies European technical conformity
Sterilized using ethylene oxide
Sterilized using irradiation Device for near‑patient testing

Sterilized using steam or dry heat

Device for self‑testing
Do not resterilize
This only applies to US: “Caution: Federal Law restricts this device to sale by or
Non‑sterile on the order of a licensed practitioner.”
Country of manufacture
“CC” shall be replaced by either the two letter or the three letter country code.
Do not use if package is damaged and consult instructions for use
Collection time
Sterile fluid path
Cut
Sterile fluid path (ethylene oxide)
Peel here
Sterile fluid path (irradiation)
Collection date

Fragile, handle with care

Keep away from light

Keep away from sunlight Hydrogen gas is generated

Keep dry
Perforation

Lower limit of temperature

Start panel sequence number

Upper limit of temperature

End panel sequence number
Temperature limit
Internal sequence number
Humidity limitation
Medical device
Biological risks
Contains hazardous substances
Do not re‑use
Ukrainian conformity mark
Consult instructions for use or consult electronic instructions for use
Meets FCC requirements per 21 CFR Part 15
Caution
UL product certification for US and Canada
Contains or presence of natural rubber latex
Unique device identifier
In vitro diagnostic medical device

Negative control

Positive control

Contains sufficient for <n> tests

For IVD performance evaluation only

Non‑pyrogenic

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