Product Manual

1 of 1
For In Vitro Diagnostic Use
INTENDED USE
For use as a leukocyte reagent to differentiate
subpopulations of white blood cells on COULTER
A
C
•T 5diff hematology analyzers. Intended for use only
with specific A
C
•T 5diff reagents. Refer to your instrument
product manuals and/or online help, as applicable.
SUMMARY
COULTER A
C
•T 5diff Fix reagent, a deep blue aqueous
solution, is used to lyse erythrocytes (red blood cells), fix
leukocytes (white blood cells), and differentially stain the
granules of lymphocytes, monocytes, neutrophils, and
eosinophils.
PRINCIPLES
COULTER A
C
•T 5diff Fix reagent is an alcohol solution
that includes propylene-glycol, a formic dye, buffers,
alkaline salts, wetting agents, and an aldehyde
preservative.
When an aliquot of whole blood is mixed with the
A
C
•T 5diff Fix reagent, the alkaline salts in the reagent
serve as a lytic reagent to stromatolyse the erythrocytes
either reducing them to very small particles or causing
membrane solubilization. As the A
C
•T 5diff Fix reagent is
destroying the red cell membranes, it preserves the
leukocytes at their original size and differentially stains the
lymphocytes, monocytes, neutrophils, and eosinophils.
The eosinophils stain the most intensely.
The lymphocytes, monocytes, neutrophils, and eosinophils
each have a unique nuclear and morphologic structure
and staining intensity; therefore, each absorbs light
differently. A specialized hydrodynamic focusing process
(Dual Focused Flow or DFF) uses A
C
V (Absorbance
Cytochemistry and Volume) Technology to develop a
DiffPlot from which four of the five leukocyte populations
are determined ⎯ lymphocytes, monocytes, neutrophils,
and eosinophils.
REACTIVE INGREDIENTS
Propane-1, 2 diol....................................................<3.00%
Formic Dye.............................................................<0.004%
WARNINGS
 Product contains >1% Propylene Glycol.
 Do not inhale and/or ingest.
 Avoid eye contact. If product is splashed in eyes, wash
eyes gently under running water for 15 minutes or
longer.
 Avoid skin contact. In case of skin contact, wash area
with soap and water. Rinse well with water.
 DO NOT REUSE CONTAINER.
STORAGE, STABILITY, AND DISPOSAL
 Store and use COULTER A
C
•T 5diff Fix at 18-25°C.
 Do not use product past expiration date.
 Opened containers are stable for 3 months when used
at 18-25°C.
Stability only applies to the reagent when
connected to the instrument with an approved reagent
pickup tube and cap.
 Dispose of waste product, unused product, and
contaminated packaging in compliance with federal,
state, and local regulations.
 DISCARD PRODUCT IF FROZEN.
PREPARATION
COULTER A
C
•T 5diff FIX reagent is ready to use. Replace
the reagent container as directed in your instrument
product manuals and/or online help.
IMPORTANT: DO NOT USE this product if it has been
partially or completely frozen. Dispose of product in
compliance with federal, state, and local regulations.
PRODUCT AVAILABILITY
COULTER A
C
•T 5diff Fix - 1 x 1 L
8547171
TRADEMARKS
A
C
•T, Beckman Coulter Logo, and COULTER are
trademarks of Beckman Coulter, Inc.
U.S. Patent Document Numbers 3,549,994 and 4,485,175.
For additional information or if damaged product is
received, call Beckman Coulter Customer Service at
800-526-7694 (USA or Canada) or contact your local
Beckman Coulter Representative.
Manufactured for:
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
www.beckmancoulter.com
Beckman Coulter Ireland Inc.
Mervue Business Park,
Mervue, Galway,
Ireland (353 91 774068)
Printed in France
Made in France
© 2010 Beckman Coulter, Inc.
All Rights Reserved.
COULTER
®
A
C
•T™ 5diff Fix
8547171
PN 772264-AA