Coulter International Corp.

Coulter Corporation

Carole Jo Young

Yi Li

Timothy J Fischer

Jing Li

Michael N Elliott

Nancy R Naylor

James H Carter

Mirta I Riesgo

Sergio C Veulens

Robert H Raynor

A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Quality control method

Hematological reference control composition containing leukocyte analogs, methods of making, and uses thereof

This invention relates to lytic reagents and methods of using the lytic reagents for automatically determining leukocyte subpopulations in blood. More specifically, the new lytic reagents selectively lyse red blood cells and certain leukocyte subpopulations, which enables the differentiation of at least one subpopulation of leukocytes. The lytic reagents contain an ethoxylated long chain amine, a quaternary ammonium salt and an acid. When used in combination with a second lytic reagent system, one is able to obtain at least a five part differential of leukocytes by impedance and light scatter measurements, by impedance and radio frequency measurements, or by radio frequency and light scatter measurements.

Composition and method for differentiation of basophils and eosinophils in blood

An improved isotonic multipurpose blood diluent, and a method for use of this diluent is provided. The diluent is especially suitable for electronic enumeration and sizing of blood cells, determination of hemoglobin parameters and differentiation of leukocyte subpopulations in a single blood cell sample using a cyanide free lytic reagent. The diluent finds particular applicability over wide operating temperatures.

Blood diluent

A method is provided for differentiation of nucleated red blood cells. In addition, the method provides for a concurrent differentiation of leukocytes in a blood cell sample by suitable electronic and optical measurements. The method includes exposing a blood cell sample to a reagent system to lyse mature red blood cells and subsequently analyzing nucleated red blood cells in a flow cell by optical analysis. A concurrent differentiation of nucleated blood cells and leukocytes can be performed using electronic and optical analysis. The electronic and optical analysis includes light scatter and impedance measurements. This method eliminates the use of nuclear stain for identification of nucleated red blood cells. The method of the present invention, for the first time, reports differentiation and enumeration of nucleated red blood cells without using fluorescence.

Method for differentiation of nucleated red blood cells

A cyanide-free lytic reagent composition and method for measuring the total hemoglobin concentration in a blood sample, for counting the number of leukocytes and for deferential counting of leukocyte subpopulations are described. The cyanide-free lytic reagent composition cotains a quaternary ammonium salt or a pyridinium salt to lyse erythrocytes and release hemoglobin, and an organic ligand including triazole and its derivatives, tetrazole and its derivatives, alkaline metal salts of oxonic acid, melamine, aniline-2-sulfonic acid, quinaldic acid, 2-amino-1,3,4-thiadiazole, triazine and its derivatives, urazole, DL-pipecolinic acid, isonicotinamide, anthranilonitrile, 6-aza-2-thiothymine, 3-(2-thienyl)acrylic acid, benzoic acid and alkali metal and ammonium salts of benzoic acid, and pyrazine and its derivatives to form a stable chromogen with hemoglobin, and a salt to adjust conductivity of the reagent for impedance measurement. The reagent composition is mixed with a blood sample without pre-dilution and the UV absorption of the sample mixture is measured at the predetermined absorption wavelength. Counting the number of leukocytes and differential counting of leukocyte subpopulations are accomplished simultaneously on an automated cell counter utilizing DC impedance measurement.

Composition and method for hemoglobin and cell analysis

A method is provided for differentiating leukocyte subpopulations, immunophenotyping of lymphocytes and counting white blood cells. The method preserves leukocyte morphology and surface markers without using fixatives. In addition, the method finds utility in determination of hemoglobin concentration without using cyanide. The stable hemoglobin chromogen formed is measured at approximately 540 nm.

Method for determination of leukocytes and hemoglobin concentration in

A method is provided for differentiation of reticulocytes. In addition, the method provides for a concurrent differentiation of leukocyte subpopulations in a blood cell sample by suitable electronic and optical measurements. The method includes exposing a blood cell sample to a reagent system to lyse mature red blood cells and subsequently analyzing reticulocytes in a flow cell by optical analysis. A concurrent differentiation of reticulocytes and leukocytes can be performed using electronic and optical analysis. The electronic and optical analysis includes light scatter and impedance measurements. This method does not require the use of nuclear stain for differentiation of reticulocytes.

Method for differentiation of reticulocytes in blood

A lytic reagent composition is provided which selectively stromatolyses red blood cells in a blood sample. In addition, a lytic reagent system is provided which enable the differentiation of at least two subpopulations of leukocytes. A method for using the lytic reagent system is also provided. Still further, the lytic reagent system find use in the determination of the hemoglobin in the blood. The lytic reagent system utilizes an ethoxylated long chain compound based lysis reagent with an acid and a solubilizer, and a hypertonic, alkaline, stabilizing reagent. The system and analysis method maintains the cellular morphology of the leukocytes and can be used to analyze normal and abnormal blood samples, fresh and aged blood, human and non-human animal blood samples, as well as other fluid samples such as bone marrow.

Reagent and method for differential determination of leukocytes in blood

A reagent composition which does not contain cyanide ions and a method for measuring hemoglobin concentration in a blood sample. In addition, the reagent composition can be used to measure hemoglobin concentration and differentiate at least two subpopulations of leukocytes from the same reaction product of the reagent composition and a blood sample. The reagent composition comprises at least one lysing agent selected from the group consisting of a quaternary ammonium salt, a pyridinium salt, and combinations thereof, in an amount effective to adequately lyse the erythrocytes and elute the hemoglobin, an antioxidant in an amount effective to convert the released hemoglobin into to a hemochromogen. The pH can be adjusting with a pH agent to provide a pH ranging from 5 to 11.5.

Cyanide-free reagent and method for hemoglobin determination and

This invention relates to a lytic reagent and a method of using the lytic reagent for automatically determining leukocyte subpopulations in blood. More specifically, the new lytic reagent lyses red blood cells and affects the eosinophils which enables the differentiation of at least one subpopulation of leukocytes. The lytic reagent is an acidic, hypertonic aqueous solution containing alkali metal salt of alkyl sulfite, an eosinolytic agent, a nonionic surfactant and a physiological salt. When used in combination with a second lytic reagent system, one is able to obtain at least a five part differential of leukocytes using DC and RF measurements.

A lytic reagent composition is provided which selectively stromatolyses red blood cells in a blood sample. In addition, a lytic reagent system is provided which enables the differentiation of at least three subpopulations of leukocytes. A method for using the lytic reagent system is also provided. Still further, the lytic reagent system finds use in the determination of the hemoglobin in the blood. The lytic reagent system utilizes an alkyl sulfate, polyoxyethylene based surfactant and acid with a hypertonic, alkaline, stabilizing reagent. The system and analysis method maintains the cellular morphology of the leukocytes and can be used to analyze normal and abnormal blood samples, fresh and aged blood, human and non-human animal blood samples.

A cyanide-free lytic reagent composition and method for measuring the total hemoglobin concentration in a blood sample, for counting the number of leukocytes and for deferential counting of three leukocyte subpopulations including lymphocytes, monocytes, and granulocytes are described. The cyanide-free lytic reagent composition includes a hemolytic surfactant chosen from quaternary ammonium salts, pyridinium salts, organic phosphate esters, and alkyl sulfonates to lyse erythrocytes and release hemoglobin, and an organic ligand chosen from triazole and its derivatives, tetrazole and its derivatives, alkaline metal salts of oxonic acid, melamine, aniline-2-sulfonic acid, quinaldic acid, 2-amino-1,3,4-thiadiazole, triazine and its derivatives, urazole, DL-pipecolinic acid. isonicotinamide, anthranilonitrile, 6-aza-2-thiothymine, adenine, 3-(2-thienyl)acrylic acid, benzoic acid and alkali metal and ammonium salts of benzoic acid, and pyrazine and its derivatives to form a stable chromogen with hemoglobin. The lytic reagent composition has a pH ranging from about 1 to about 13. The lytic reagent composition is mixed with a blood sample which is prediluted with a suitable blood diluent and the UV absorption of the sample mixture is measured at the predetermined absorption wavelength of the formed chromogen from 510 nm to 560 nm. Counting the numbers of leukocytes and differential counting of three leukocyte subpopulations are accomplished simultaneously on an automated cell counter utilizing DC impedance measurement. Alternatively, the organic ligands can be added to a suitable blood diluent for hemoglobin and leukocyte analysis.

Cyanide-free lytic reagent composition and method for hemoglobin and

A lytic reagent composition is provided which selectively stromatolyses red blood cells in a blood sample. In addition, a lytic reagent system is provided which enable the differentiation of at least two subpopulations of leukocytes. A method for using the lytic reagent system is also provided. Still further, the lytic reagent system find use in the determination of the hemoglobin in the blood. The lytic reagent system utilizes an ethoxylated long chain compound based lysis reagent with an acid and a hypertonic, alkaline, stabilizing reagent. The system and analysis method maintains the cellular morphology of the leukocytes and can be used to analyze normal and abnormal blood samples, fresh and aged blood, human and non-human animal blood samples, as well as other fluid samples such as bone marrow.

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Miami, FL, United States of America

Carole Jo Young