Product Manual

ManualsBrandsBeckman Coulter ManualsMedical Supplies & EquipmentCOULTER AC T Tainer Reagent Kit

1 of 1

For In Vitro Diagnostic Use

INTENDED USE

For use on COULTER A

•T™ 8 and A

•T 10 hematology

analyzers only. Refer to your instrument product manuals.

REAGENT 1 - COULTER Balanced Electrolyte Solution

For use as a diluent for counting and sizing blood cells.

REAGENT 2 - COULTER Lytic Reagent

For use as a lytic agent for the quantitative determination

of hemoglobin and for leukocyte counting and sizing.

REAGENT 3 – COULTER

Shutdown Diluent

For use as a shutdown diluent for hematology analyzer

components that come in contact with blood samples,

including apertures.

SUMMARY

Blood cell analysis comprises diluting a whole-blood

sample with a solution that functions as a diluent. The

diluent (Reagent 1) provides the ability to analyze portions

of the diluted blood sample for different blood cell types,

such as red blood cells and platelets. When combined with

the lytic reagent (Reagent 2), the diluent (Reagent 1) is

useful in the quantitative determination of hemoglobin, the

enumeration of leukocytes (white blood cells), and on the

•T 10 analyzers, the derivation of leukocyte

subpopulations. The biodegradable shutdown diluent

(Reagent 3) aids in the removal of protein buildup in the

sensing orifices of the hematology analyzer.

PRINCIPLES

The diluent (Reagent 1) is a chemical composition of

organic buffers, anesthetics, and germicides in an

osmotically balanced neutral solution that includes the

following:

 Sodium chloride allows the diluent to become an

electrolyte capable of conducting electrical current in

an electronic analyzer and, along with Sodium Sulfate

and Procaine Hydrochloric Acid, provides buffer for pH

balance and cell component stabilization (that is,

becoming an isotonic solution, stabilizing blood cell

volume, and reducing turbidity in the measurement of

hemoglobin).

 Dimethylolurea, an antiseptic, is for product

preservation against microbial growth.

In this capacity, the diluent (Reagent 1) is useful for the

determination of red blood cell and platelet

measurements. Combined with the lytic reagent

(Reagent 2), the diluent is used for the determination of

hemoglobin, the enumeration of leukocytes (white blood

cells), and on the A

•T 10 analyzer, determination of the

leukocyte lymphoid population (LY% and LY#).

The lytic reagent (Reagent 2) consists of quaternary

ammonium salts whose surface active properties destroy

the red cell membrane, thus lysing the red blood cells

(stromatolyzation) and reducing the size of cellular debris

to a level that does not interfere with leukocyte counts. On

the A

•T 10 analyzer, the lytic reagent causes shrinkage of

the leukocytes into predictable volume components that

allow for the determination of a leukocyte lymphoid

population (LY% and LY#). Additionally, the reaction of the

quaternary ammonium salts functions to reduce the

amount of protein buildup in the sensing orifices of the

instrument. Potassium cyanide is used to form a suitable

chromagen for hemoglobin determination.

Blood proteins flowing through blood counting orifices

(apertures) in a hematology analyzer over time

accumulate around these openings to a point that the size

of the orifices are minimized and eventually blocked. The

proteolytic enzyme in the shutdown diluent (Reagent 3)

reacts with and dissolves the protein in and around the

apertures.

REACTIVE INGREDIENTS

The COULTER A

•T Tainer Reagent Kit contains the

following:

REAGENT 1 - COULTER Balanced Electrolyte Solution

Sodium Sulfate ............................................ 9.72 g/L

Sodium Chloride.......................................... 4.0 g/L

Dimethylolurea............................................. 1.0 g/L

Procaine HCL .............................................. 0.11 g/L

REAGENT 2 - COULTER Lytic Reagent

Quaternary Ammonium Salts ...................... 19-26 g/L

Isopropanol.................................................. 1-2%

Potassium Cyanide ..................................... 0.15-0.5 g/L

REAGENT 3 - COULTER Shutdown Diluent

A solution of a proteolytic enzyme

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.

 Keep package intact for proper performance. This is a

single unit package and is to be used as such.

 DO NOT REUSE CONTAINERS.

STORAGE, STABILITY, AND DISPOSAL

 Store COULTER A

•T Tainer Reagent Kit at 2-25°C.

 Do not use product past expiration date.

 Use product at temperatures stated in the instrument

product manuals.

 Opened containers are stable for 30 days when used

at 16-25°C.

 Dispose of waste product, unused product, and

contaminated packaging in compliance with federal,

state, and local regulations.

PREPARATION

Reagents in the COULTER A

•T Tainer Reagent Kit are

ready to use. For instructions regarding reagent

replacement or use of the enclosed management card,

refer to your instrument product manuals.

To avoid cross contamination when replacing the

COULTER A

•T Tainer Reagent Kit, transfer pickup tubes

one at a time beginning with Reagent 1 (diluent), then

Reagent 2 (lytic reagent), and finally Reagent 3 (shutdown

diluent).

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 kit as directed in

your instrument product manuals. Verify background

counts are acceptable before analyzing patient samples.

REFERENCES

1. Lin Y, Means GE, and Feeney RE. 1969. Action of

proteolytic enzymes on N,N-dimethyl proteins. Basis

for a microassay for proteolytic enzymes. J Biol Chem,

244(3):789-793.

PRODUCT AVAILABILITY

COULTER A

•T Tainer Reagent Kit

8547111

(Contains 1 x 4 L Reagent 1; 1 x 190 mL Reagent 2; and

1 x 250 mL Reagent 3)

TRADEMARKS

•T, A

•T Tainer, Beckman Coulter logo, and COULTER

are trademarks of Beckman Coulter, Inc.

U.S. Patent Document Numbers: 4,346,018; 4,521,518;

4,485,175; 4,528,274; and 4,962,038

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

COULTER

•T Tainer™

Reagent Kit

8547111

PN 772248-AA

Summary of content (1 pages)

PAGE 1
COULTER® AC•T Tainer™ Reagent Kit (stromatolyzation) and reducing the size of cellular debris to a level that does not interfere with leukocyte counts. On C the A •T 10 analyzer, the lytic reagent causes shrinkage of the leukocytes into predictable volume components that allow for the determination of a leukocyte lymphoid population (LY% and LY#). Additionally, the reaction of the quaternary ammonium salts functions to reduce the amount of protein buildup in the sensing orifices of the instrument.