Product Manual

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For In Vitro Diagnostic Use
INTENDED USE
For use as an erythrocyte lytic reagent for leukocyte
counting and basophil differentiation 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 WBC Lyse, an acidic solution
containing a lytic reagent, is used to destroy the red cell
membrane so that the white blood cell (WBC) count and
differentiation of polynuclear basophils (BASO) can be
accomplished.
PRINCIPLES
The methodology used to determine the WBC count and
BASO (basophil) count uses differential lysis, impedance
technology, and differential thresholds.
When an aliquot of whole blood is mixed with A
C
•T 5diff
WBC Lyse reagent, the lytic reagent stromatolyses the red
blood cells either reducing them to very small particles or
causing membrane solubilization, leaving the basophils
and other white blood cells to be counted by volume. The
WBC count and basophil count are determined
simultaneously using the Coulter Principle. Differentiation
between basophils and other white blood cells is related to
the A
C
•T 5diff WBC Lyse-specific lytic action on these
white blood cells and development of the WBC/BASO
histogram needed to determine the basophil percentage.
REACTIVE INGREDIENTS
Hydrochloric Acid ...................................................<0.03%
Detergent................................................................<0.5%
WARNINGS
 Do not inhale and/or ingest.
 Avoid eye and skin contact. In case of eye or skin
contact, flush affected area with copious amounts of
water for at least 15 minutes.
 DO NOT REUSE CONTAINER.
STORAGE, STABILITY, AND DISPOSAL
 Store and use COULTER A
C
•T 5diff WBC Lyse at
18-25°C.
 Do not store product in direct sunlight.
 Do not use product past expiration date.
 Opened containers are stable for 8 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 WBC Lyse 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 WBC Lyse - 1 x 1 L
8547170
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 WBC Lyse
8547170
PN 772263-AA