Assay devices with integrated sample dilution and dilution verification and methods of using same
First Claim
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1. 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.
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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.
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Citations
12 Claims
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1. 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:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification