Dried reagent polysaccharide surface area stabilization
AssigneeSiemens Healthcare Diagnostics Inc.
InventorAaron Kauffmann
Life of this patent
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Abstract
Non-limiting embodiments of a modified solid reagent zone comprising at least hydrophilic polysaccharide and/or at least one hydrophilic non-polysaccharide polymer for use in the conductance of at least one diagnostic assay, as well as kits and methods of use and production related thereto.
Claims16
An analytical reaction kit, the kit comprising:
- a housing for conducting at least one diagnostic assay, wherein the housing comprises a reaction chamber that comprises at least one solid reagent zone, wherein the at least one solid reagent zone comprises at least one antibody reagent zone for the detection of at least one analyte of interest present in a patient's liquid test sample, the at least one antibody reagent zone comprising:
- at least one antibody,
- at least one monosaccharide, disaccharide, sugar alcohol, or combinations thereof, and
- carboxymethylcellulose,
- wherein carboxymethylcellulose is added to the at least one monosaccharide, disaccharide, sugar alcohol, or combination thereof to increase tensile strength and thereby reduce fracturing of a surface area of the solid reagent zone when compared to a solid reagent zone prepared in the absence of carboxymethylcellulose, and wherein the solid reagent zone has a stabilized surface area with substantially no fracturing and substantially no gritty surface after at least three weeks of storage at room temperature;
- and
- a liquid analytical reagent dispensing apparatus contained within the housing, the apparatus comprising:
- a container, wherein the container contains at least one liquid analytical reagent, the container being in fluid communication with the reaction chamber to thereby dispense the at least one liquid analytical reagent.
A method for increasing tensile strength at least one solid reagent zone for use in at least one diagnostic assay, wherein the at least one solid reagent zone comprises at least one antibody for the detection of at least one analyte of interest present in a patient's liquid test sample, the method comprising the steps of:
- forming at least one solid reagent zone precursor, wherein the solid reagent zone precursor comprises at least one monosaccharide, disaccharide, sugar alcohol, or combinations thereof in liquid state;
- adding a predetermined concentration of carboxymethylcellulose to the at least one solid reagent precursor;
- and
- drying the at least one solid reagent precursor to thereby form at least one stabilized solid reagent zone for use in the conductance of one or more diagnostic assays;
- wherein at least one of:
- the solid reagent zone has a stabilized surface area with substantially no fracturing and substantially no gritty surface after at least three weeks of storage at room temperature;
- the solid reagent zone has a stabilized surface area that reduces a reaction time for detection of the at least one diagnostic assay when compared to a solid reagent zone prepared in the absence of carboxymethylcellulose;
- and/or
- the solid reagent zone has a stabilized surface area that reduces a percent bias of the at least one diagnostic assay when compared to a solid reagent zone prepared in the absence of carboxymethylcellulose.
An analytical reaction kit, the kit comprising:
- a housing for conducting at least one diagnostic assay, wherein the housing comprises a reaction chamber for the conductance of one or more diagnostic assays, the reaction chamber further comprising at least one solid reagent zone, wherein the at least one solid reagent zone comprises at least one antibody reagent zone for the detection of at least one analyte of interest present in a patient's liquid test sample, the at least one antibody reagent zone comprising:
- at least one antibody,
- at least one monosaccharide, disaccharide, sugar alcohol, or combinations thereof, and
- carboxymethylcellulose,
- wherein carboxymethylcellulose is added to the at least one monosaccharide, disaccharide, sugar alcohol, or combination thereof to increase tensile strength of a surface area of the solid reagent zone and reduce fracturing thereof when compared to a solid reagent zone prepared in the absence of;
- and
- wherein at least one of:
- the increased tensile strength of the surface area of the solid reagent zone reduces a reaction time for detection of the at least one diagnostic assay when compared to a solid reagent zone prepared in the absence of carboxymethylcellulose;
- and/or
- the increased tensile strength of the surface area of the solid reagent zone reduces a percent bias of the at least one diagnostic assay when compared to a solid reagent zone prepared in the absence of carboxymethylcellulose;
- and
- a liquid analytical reagent dispensing apparatus contained within the housing, the apparatus comprising:
- a container, wherein the container contains at least one liquid analytical reagent, the container being in fluid communication with the reaction chamber to thereby dispense the at least one liquid analytical reagent.
Dependencies are inferred from the claim text.