Technicon Instruments Corporation

Bayer Corporation

Siemens Healthcare Diagnostics Gmbh

Michael J Malin

John F Cremins

Phyllis Shapiro

Louis D Sclafani

Leonard Ornstein

Young R Kim

Jeffrey Benezra

Bernard Loev

David Zelmanovic

Gena Fischer

Martin J Lee

Deng R Hwang

Jolanta Kunicka

Pamela Elsins

Young Ran Kim

The present invention describes semi- and fully-automated methods and reagents therefor for the assay and analysis of body fluid samples, particularly non-blood samples. The methods and reagents are especially useful for the assay and analysis of cerebrospinal fluid (CSF) samples. The reagent compositions sphere and fix all cells in the sample in suspension. Reported results can include red blood cell (RBC) and white blood cell (WBC) counts, WBC differential values, cell-by-cell volumes and dry-mass concentrations.

Automated method and reagent therefor assaying body fluid samples such as cerebrospinal fluid (CSF)

The invention provides a new method and system for detecting and monitoring extracellular or exogenously added hemoglobin, i.e., a cell-free hemoglobin substitute or derivative, in a blood, plasma, or serum sample of an individual, particularly a whole blood sample. The invention further describes the use of automated hematology analyzers to determine and quantify at the same time the concentration of total, cellular and exogenous hemoglobin in a blood, plasma, or serum sample, and is particularly advantageous for medical use during or after patient trauma or surgery, as well as for monitoring hemoglobin levels during patient recovery.

Automated method for detecting, quantifying and monitoring exogenous hemoglobin in whole blood, plasma and serum

The invention provides a bicarbonate-containing, crosslinker-free reagent composition which reverses and/or reduces sample handling effects, such as aeration-induced shrinkage and storage-induced swelling of cells in a whole blood sample, particularly for a blood sample requiring repeated sampling and/or subjected to long-term storage. The reagent composition serves as a diluent medium for a blood sample, or an aliquot or portion thereof. The pH of the reagent is in the range of about 7.2 to about 7.5, preferably 7.3. The stability of the pH 7.2-7.5 bicarbonate-containing reagent over time is maintained by storing the reagent in a flexible collapsible container which is impermeable to carbon dioxide and is comprised of a multilayered flexible material, preferably plastic, and attachable to a hematology analyzer.

METHOD AND LONG-TERM STABLE BICARBONATE-CONTAINING DILUENT COMPOSITION, AND STORAGE MEANS THEREFOR, FOR REDUCING OR REVERSING AERATION INDUCED CELL SHRINKAGE AND STORAGE INDUCED CELL SWELLING OF A WHOLE BLOOD SAMPLE

The present invention provides a heretofore unknown use for a aqueous reagent composition that serves as a universal rinse for performing and/or improving a variety of hematological analyses on automated analyzers. The universal rinse reagent comprises a phosphate buffer to maintain the rinse solution pH at from about 7.0 to about 7.6; a nonhemolytic nonionic surfactant, such as a Pluronic.RTM. an alkali metal salt, such as NaCi; antimicrobial and anti-oxidant compounds; and has an osmolality of about 285 to 305 mOsmol/kg. The universal rinse reagent composition is highly suitable for use in the rinse phases or cycles of all types of blood cell analysis methods and processes performed on semi- and fully-automated systems. The invention allows the replacement of mutiple and specific rinse solutions with the disclosed universal rinse to obtain accurate and acceptable results, independent of the types of blood cell analyses that are performed. The universal rinse is most particularly useful for automated systems having intricate hardware and a number of different input and output channels. The universal rinse composition serves to economize, streamline, and simplify the design and operation of such systems.

Universal rinse reagent and method for use in hematological analyses of

The invention describes an improved stable reagent composition and method for the determination of hemoglobin (Hb) using whole blood samples and automated hematology analyzers. The Hb reagent contains an inorganic cyanide salt, at least one surfactant and a base and has a final pH of about 10.0 to about 11.2, preferably about 10.4 to about 11.2 or less and more preferably about 10.8 to about 11.2 or less. This reagent is intended for use as a universal Hb determination reagent for all of the instruments in the aforementioned series and will provide accurate and precise results without accompanying interference from elevated numbers of white blood cells, especially as found in abnormal blood specimens, and without system-to-system variation in the results obtained.

Cyanide-containing hemoglobin reagent composition and method providing

The present invention provides an improved reagent composition and method to perform white blood cell differential counting and subpopulation analysis using both fresh and aged blood samples with accuracy and precision. The invention is particularly applicable for the analysis of aged blood samples that have been stored at room temperature for over a day, thereby allowing accurate and useful information to be obtained from samples that are normally considered to be suboptimal. The improved reagent composition and method are particularly related to the peroxidase method of white blood cell differential determinations. One aspect of the invention includes an improved aqueous reagent composition for carrying out the peroxidase method of differential counting. Another aspect includes the use of a rinse cycle and rinse solution devoid of hemolytic surfactant to alleviate the adverse effects of rinse carryover and to streamline and economize the analytical process, particularly when the analyses are performed on automated hematology analyzers and flow cytometry systems. The composition and method of the invention provide clinically useful data for the differential analysis of whole blood samples.

Method and reagent composition for performing leukocyte differential

A novel method and reagent useful therein are cyanide-free and capable of providing a rapid indication, e.g., less than 30 seconds, of total hemoglobin in a blood sample, so as to find particular application in automated hematological instrumentation. The novel reagent comprises an ionic surfactant, a pH of at least about 11.3 and is free of ionic cyanide. The ionic surfactant itself can impart the required pH or a strong base independent of such surfactant may be included.

Cyanide-free hemoglobin reagent

This invention relates to a method for the rapid determination of a differential white blood cell count in a sample, which method comprises:

Reagent for the determination of a differential white blood cell count

A method and reagent useful therein are cyanide-free and capable of providing a rapid indication, e.g., less than 30 seconds, of total hemoglobin in a blood sample, so as to fine particular application in automated hematological instrumentation. The novel reagent comprises an ionic surfactant, a pH of at least about 11.3 and is free of ionic cyanide. The ionic surfactant itself can impart the required pH or a strong base independent of such surfactant may be included.

Method for the determination of a differential white blood cell count

This invention relates to a novel stabilized aqueous hydrogen peroxide solution which comprises hydrogen peroxide in admixture with an aromatic polysulfonic acid, or a salt thereof.

Stabilized aqueous hydrogen peroxide solution

New phthalocyanin derivatives which can be used to differentiate basophils from other blood cells are disclosed. The compounds to which the present invention are quaternary salts of a substituted phthalocyanin structure wherein the substitutions are each independently hydrogen, sulfonate, or a C.sub.1 -C.sub.7 hydrocarbon, optionally containing at least one heteroatom, with the proviso that at least one of them is ##STR1## in which R.sub.1 -R.sub.3 are each independently lower alkyls, cycloalkyls or olefins of which at least one is C.sub.2 -C.sub.4 and two may join to form a ring; R.sub.4 is hydrogen or a C.sub.1 -C.sub.3 alkyl; n is an integer from 1 to 6; M is a polyvalent metal ion. It is preferred that at least two and especially at least three substitutions have the structure so set forth.

Quaternized phthalocyanin derivatives

A heat-stable, polymer-forming composition of a polymerizable material, a transition metal compound, a polymer chain terminator, and, optionally, a preventive antioxidant is disclosed as well as particular uses of such composition.

Heat stable, polymer-forming composition

Method and apparatus for analyzing whole blood samples which feature impregnating a gel medium used for the analysis of the whole blood sample with an inert substance. When the whole blood sample is placed on the gel medium, the inert substance diffuses from the gel as the plasma solutes of the blood diffuse into the gel. The amount of the inert substance diffusing from the gel medium is inversely proportional to the hematocrit of the blood sample. In one embodiment, plasma solutes are caused to react with one or more reagents in the gel medium to assay various specific analytes. Also, the hematocrit, indicated by the diffusion rate of the inert substance from the gel, is determined and used to correct such assay.

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Park Ridge, NJ, United States of America

Michael J Malin