Diagnostic device and method
AssigneeUniversity of Utah Research Foundation
InventorsJames N. Herron, Douglas A. Christensen, Jacob D. Durtschi
Life of this patent
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Abstract
A method and apparatus of diagnosing a cardiac disease state in as little as two minutes involving the utilization of an evanescent wave assay system in conjunction with a data acquisition and analysis procedure that monitors the precision of assay results in real time (i.e., while data is being acquired). The method includes diagnosing a disease state using a diagnostic procedure (e.g., an immunoassay) wherein the testing device informs the person conducting the test of the results of the test as soon as reliable test data is obtained (generally, <5% variation in the reaction rate of the assay). After which point, the diagnostic procedure may be terminated.
Claims19
A method of performing an assay comprising:
- providing an assay system which receives a biological liquid sample potentially containing at least one analyte of interest and outputs a light signal indicative of the rate of reaction between said analyte of interest and a reactive element within the assay system;
- continuously measuring light emitted from said assay system over time;
- continuously correlating said rate of reaction to a concentration of said analyte of interest;
- and
- determining the concentration of at least one analyte of interest in said biological liquid sample based on said correlation of said light in a time period less than about five minutes.
An assay system for analyzing a biological liquid sample, comprising:
- a light source;
- a waveguide having at least one planar surface and being optically associated with a rear lens oriented for reading light from said light source passing through said waveguide, to monitor coupling efficiency and beam quality;
- a first member associated in liquid tight attachment with said waveguide, wherein said first member, in conjunction with the waveguide, defining at least one reservoir for containing the biological liquid sample while a planar surface of the waveguide defines a floor or ceiling of said reservoir, the planar surface being associated in part with capture molecules;
- an inlet and outlet in fluid communication with said reservoir for infusing and draining said biological liquid into said reservoir so as to allow the biological liquid to contact said capture molecules;
- a light detector for detecting light passed through said planar surface, which generates a signal indicating the intensity of said detected light;
- and
- a controller for monitoring the intensity signal and correlates said signal to the concentration of said analyte of interest in said biological sample.
A method of diagnosing a cardiac disease state in a patient, the method comprising:
- providing an assay system which:
- receives a biological liquid sample from the patient, the sample potentially containing at least one analyte selected from the group consisting of troponin-I, CK-MB, myoglobin, and mixtures thereof;
- and
- outputs a light signal indicative of a reaction between said at least one analyte and a reactive element within the assay system;
- continuously measuring light emitted from said assay system over time;
- continuously correlating the reaction to a concentration of said at least one analyte;
- and
- determining the concentration of said at least one analyte in said biological liquid sample based on said correlation of said emitted light in a time period less than about five minutes.
Dependencies are inferred from the claim text.