METHOD OF REDUCING THE SENSITIVITY OF ASSAY DEVICES
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Abstract
A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a scavenging zone that contains a capture reagent for the analyte of interest. The capture reagent may capture a quantity of the analyte that is less than or equal to a predefined base quantity of the analyte, such as a quantity considered “normal” for a particular test sample. Thus, the capture reagent is able to prevent some of the analyte from being detected. In this manner, the sensitivity of the assay device may be reduced in a simple, inexpensive, yet effective manner.
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Citations
51 Claims
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1. (canceled)
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3-4. -4. (canceled)
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7-11. -11. (canceled)
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13-36. -36. (canceled)
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37. A method for detecting an analyte in a test sample, the method comprising:
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i) providing an assay device that comprises; a sampling pad that defines a scavenging zone in which is non-diffusively immobilized a first capture reagent configured to specifically bind with the analyte; a conjugate pad that contains detection probes and optional calibration probes, the detection probes being conjugated with a first binding member configured to specifically bind with the analyte; and a porous membrane in fluid communication with the sampling pad and the conjugate pad, the porous membrane defining a detection zone in which is immobilized a second capture reagent configured to specifically bind with the analyte and a calibration zone within which is immobilized a polyelectrolyte having a net charge opposite to that of and configured to bind with the detection probes, the calibration probes, or combinations thereof, wherein the detection zone and the calibration zone are located downstream from the sampling pad and the conjugate pad; ii) contacting the assay device with the test sample, wherein a quantity of the analyte in the test sample less than or equal to a predefined base quantity binds to the first capture reagent at the scavenging zone and a quantity of the analyte in excess of the predefined base quantity binds to the specific binding member of the detection probes to form complexes that flow through the porous membrane and bind to the second capture reagent in the detection zone to generate a detection signal, and wherein the detection probes, the calibration probes, or a combination thereof, flow through the porous membrane and bind to the third capture reagent at the calibration zone to generate a calibration signal; iii) detecting the intensity of the detection signal and the calibration signal; and iv) comparing the intensity of the detection signal to the intensity of the calibration signal, wherein the quantity of the analyte within the test sample in excess of the predefined base quantity is proportional to the intensity of the detection signal calibrated by the intensity of the calibration signal. - View Dependent Claims (2, 5, 6, 12, 38, 39, 40, 41, 42, 43, 44, 45, 47, 48, 49, 50, 51)
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46. (canceled)
Specification