Automated method and reagent therefor assaying body fluid samples such as cerebrospinal fluid (CSF)
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsLeonard Ornstein, Gena Fischer, David Zelmanovic, Pamela Elsins, Jolanta Kunicka, Michael J. Malin
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Abstract
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.
Claims85
A method of fixing and sphering cells in an aliquot of a body fluid, wherein the cells remain in suspension and maintain their volumes and contents for greater than 24 hours, comprising:
- mixing an aliquot of the body fluid with an aliquot of an aqueous reagent composition comprising at least one aldehyde, at least one surface-active agent and cyclodextrin.
An automated method for the analysis of a non-blood body fluid, comprising:
- (a) mixing an aliquot of the body fluid with a reagent composition comprising, in aqueous solution, at least one aldehyde, at least one surface-active agent and cyclodextrin to form a reagent mixture;
- (b) aspirating the reagent mixture into an automated analyzer;
- (c) analyzing the components in the reagent mixture virtually one cell at a time by direct cytometry;
- and
- (d) obtaining counts of cell components of the body fluid.
A composition comprising, in aqueous solution, at least one aldehyde, at least one surface-active agent and cyclodextrin.
A control material for flow cytometry analysis of cells in a body fluid, the material comprising a mixture of an aliquot of the body fluid and an aqueous reagent composition comprising at least one aldehyde, at least one surface active agent and cyclodextrin.
A method of fixing and sphering cells in an aliquot of a body fluid, wherein the cells remain in suspension and maintain their volumes and contents for greater than 24 hours, comprising:
- mixing an aliquot of the body fluid with an aliquot of an aqueous reagent composition comprising at least one aldehyde selected from the group consisting of formaldehyde, glutaraldehyde, and a combination thereof;
- at least one surface-active agent selected from zwitterionic surfactants and nonionic surfactants;
- and a cyclodextrin selected from alpha cyclodextrin, beta cyclodextrin, or gamma cyclodextrin.
An automated method for the analysis of a non-blood body fluid, comprising:
- (a) mixing an aliquot of the body fluid with a reagent composition comprising, in aqueous solution, at least one aldehyde selected from the group consisting of formaldehyde, glutaraldehyde, and a combination thereof;
- at least one surface-active agent selected from zwitterionic surfactants and nonionic surfactants;
- and a cyclodextrin selected from alpha cyclodextrin, beta cyclodextrin, or gamma cyclodextrin to form a reagent mixture;
- (b) aspirating the reagent mixture into an automated analyzer;
- (c) analyzing the components in the reagent mixture virtually one cell at a time by direct cytometry;
- and
- (d) obtaining counts of cell components of the body fluid.
The method according to claim 81 or claim 82, wherein the cyclodextrin in the reagent composition is hydroxypropyl-β-cyclodextrin.
Dependencies are inferred from the claim text.