Self-calibrated flow-through assay devices
First Claim
1. A flow-through assay device capable of detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a porous membrane, said porous membrane being in communication with detection probes capable of generating a detection signal and calibration probes capable of generating a calibration signal, said porous membrane defining a detection/calibration zone within which a polyelectrolyte capture reagent is immobilized that is configured to directly or indirectly bind to said detection probes, said calibration probes, or combinations thereof, wherein said detection probes are capable of generating a detection signal and said calibration probes are capable of generating a calibration signal while within said detection/calibration zone, wherein the amount of the analyte is capable of determination from said detection signal as calibrated by said calibration signal.
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Abstract
An internal, self-calibrated system for flow-through assay devices is provided. In particular, the present invention employs the use of a single calibration/detection zone defined by a porous membrane of the assay. It has been discovered that the internal, self-calibrated system provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.
138 Citations
40 Claims
- 1. A flow-through assay device capable of detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a porous membrane, said porous membrane being in communication with detection probes capable of generating a detection signal and calibration probes capable of generating a calibration signal, said porous membrane defining a detection/calibration zone within which a polyelectrolyte capture reagent is immobilized that is configured to directly or indirectly bind to said detection probes, said calibration probes, or combinations thereof, wherein said detection probes are capable of generating a detection signal and said calibration probes are capable of generating a calibration signal while within said detection/calibration zone, wherein the amount of the analyte is capable of determination from said detection signal as calibrated by said calibration signal.
- 19. A flow-through assay device capable of detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a porous membrane, said porous membrane being in communication with detection probes capable of generating a detection signal and calibration probes capable of generating a calibration signal, said detection probes being conjugated with a specific binding member for the analyte, said porous membrane defining a detection/calibration zone within which a polyelectrolyte capture reagent is non-diffusively immobilized that is configured to directly or indirectly bind to said calibration probes, said detection probes, or combinations thereof, wherein said detection probes are capable of generating a detection signal and said calibration probes are capable of generating a calibration signal while within said detection/calibration zone, wherein the amount of the analyte is capable of determination from said detection signal as calibrated by said calibration signal.
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30. A method for detecting the presence or quantity of an analyte residing in a test sample, said method comprising:
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i) providing a flow-through assay device comprising a porous membrane, said porous membrane being in communication with detection probes capable of generating a detection signal and calibration probes capable of generating a calibration signal, said porous membrane defining a detection/calibration zone within which a polyelectrolyte capture reagent is immobilized that is configured to directly or indirectly bind to said detection probes, said calibration probes, or combinations thereof, wherein said detection probes are capable of generating a detection signal and said calibration probes are capable of generating a calibration signal while within said detection/calibration zone;
ii) contacting a test sample containing the analyte with said detection probes and said calibration probes;
iii) measuring the intensity of the detection signal and the intensity of the calibration signal generated within said detection/calibration zone; and
iv) calibrating the intensity of the detection signal with the calibration signal, wherein the amount of the analyte within the test sample is determined from said detection signal as calibrated by said calibration signal. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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Specification