Assay devices with integrated sample dilution and dilution verification and methods of using same
AssigneeAbbott Point of Care Inc.
InventorsCary James Miller, Graham Davis, Michael Zelin
Life of this patent
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Abstract
The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.
Claims12
A method of performing an assay for an analyte in a fluid sample with a cartridge having an integrated sample dilution element, where the cartridge is adapted for insertion into a reading apparatus, the method comprising:
- (a) introducing a fluid sample into a sample holding chamber of a cartridge with a sample dilution element, wherein at least a portion of said dilution element determines a volume of sample for dilution, and wherein said dilution element further comprises a predetermined known amount of a dilution determinant marker capable of dissolving into said sample;
- (b) pumping a metered volume of diluent from a diluent chamber in said cartridge, to said sample dilution element to form a diluted sample;
- (c) introducing said diluted sample to a conjugate molecule comprising a signaling moiety;
- (d) pumping the diluted sample to a sensor in a sensing region of said cartridge;
- (e) measuring the concentration of said dilution determinant marker in said diluted sample;
- and
- (f) determining the dilution ratio of the diluted sample from said measured concentration in step (e) and said predetermined known amount of step (a),
- wherein the dilution determinant marker is a different entity from that of the conjugate molecule.
Dependencies are inferred from the claim text.