Product Manual

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For In Vitro Diagnostic Use
INTENDED USE
For use as an erythrocyte lytic agent for the quantitative
determination of hemoglobin and for leukocyte counting
and sizing on COULTER HmX, LH 500, LH 750, and
LH 780 hematology analyzers. Use with only ISOTON III
or LH Series diluent. Refer to your instrument product
manuals and/or online help, as applicable.
SUMMARY
COULTER LYSE S III diff Lytic Reagent is used as a lytic
agent to prepare a diluted whole-blood sample for the
quantitative determination of hemoglobin, the enumeration
of leukocytes (white blood cells), and the derivation of
leukocyte subpopulations.
PRINCIPLES
COULTER LYSE S III diff Lytic Reagent is a clear,
aqueous solution containing potassium cyanide and
quaternary ammonium salts.
When the lytic reagent is added to a diluted whole-blood
sample, the surface-active properties of the quaternary
ammonium salts destroy the red cell membranes, thus
lysing the red blood cells (stromatolyzation) and releasing
the hemoglobin. The released hemoglobin chemically
reacts with potassium cyanide to form a stable
hemochromagen that is quantitatively measured at an
absorbance wavelength.
As the lytic reagent is destroying the red cell membranes
to release the hemoglobin, it reduces the size of the
resulting cellular debris to a level that does not interfere
with the leukocyte (white blood cell) counts. On COULTER
hematology analyzers with histogram differential, the lytic
reagent causes differential shrinkage of the leukocytes
into predictable volume components, namely lymphocytes,
mononuclear cells, and granulocytes. Additionally, the
reaction of the quaternary ammonium salts functions to
reduce the amount of protein buildup in the sensing
orifices of the instrument.
REACTIVE INGREDIENTS
Quaternary Ammonium Salts……………………..19-26 g/L
Isopropanol............................................................1-2%
Potassium Cyanide...............................................0.15-0.5 g/L
WARNINGS
Product contains <2% Isopropyl Alcohol and
<2% Quaternary Ammonium Salts. Irritating to eyes.
Do not inhale and/or ingest.
In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.
DO NOT REUSE CONTAINER.
STORAGE, STABILITY, AND DISPOSAL
Store COULTER LYSE S III diff Lytic Reagent at
2-30°C.
Do not use product past expiration date.
Use product at temperatures stated in the instrument
product manuals and/or online help.
Opened containers are stable for 60 days when stored
as recommended.
Dispose of waste product, unused product, and
contaminated packaging in compliance with federal,
state, and local regulations.
PREPARATION
COULTER LYSE S III diff Lytic Reagent is ready to use.
Replace the reagent as directed in your instrument
product manuals and/or online help.
IMPORTANT: If product has been partially or completely
frozen, allow product to warm to room temperature. Mix
product by gentle inversion prior to placement on the
instrument. Install and prime the reagent as directed in
your instrument product manuals and/or online help. Verify
background counts are acceptable before analyzing
patient samples.
PRODUCT AVAILABILITY
COULTER LYSE S III diff Lytic Reagent - 1 x 1 L
8546983
COULTER LYSE S III diff Lytic Reagent - 1 x 5 L
8546796
TRADEMARKS
Beckman Coulter logo, COULTER and LYSE S are
trademarks of Beckman Coulter, Inc.; Beckman Coulter,
COULTER and LYSE S are registered in the USPTO and
SIPO.
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.
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
www.beckmancoulter.com
Printed in USA
Made in USA
© 2011 Beckman Coulter, Inc.
All Rights Reserved.
COULTER
LYSE S
III
diff
Lytic Reagent
8546983
8546796
PN 772260-AB

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