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Assay devices having detection capabilities within the hook effect region

  • US 7,439,079 B2
  • Filed: 04/29/2005
  • Issued: 10/21/2008
  • Est. Priority Date: 04/29/2005
  • Status: Active Grant
First Claim
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1. A method for quantitatively or semi-quantitatively detecting an analyte within a test sample, the method comprising:

  • i) contacting the test sample with a porous membrane of a lateral flow device, the porous membrane being in communication with conjugated detection probes, the conjugated detection probes being capable of generating a signal, the porous membrane defining;

    a detection zone in which is immobilized a first receptive material, the first receptive material being configured to preferentially bind to the analyte, whether complexed or uncomplexed with the conjugated detection probes;

    an indicator zone located downstream from the detection zone, wherein a second receptive material is immobilized within the indicator zone, the second receptive material being configured to preferentially bind to the uncomplexed conjugated detection probes;

    ii) measuring the intensity of a detection signal produced at the detection zone and the intensity of an indicator signal produced at the indicator zone;

    iii) comparing the measured indicator signal intensity to a reference standard, the reference standard representing an intensity or range of intensities of the indicator signal at or near a saturation concentration of the analyte;

    iv) generating a dose response curve by plotting detection signal intensity for known analyte concentrations; and

    v) converting the measured detection signal intensity to an analyte concentration or range of concentrations based on whether the measured indicator signal intensity is less than, greater than, or the same as the reference standard, wherein the concentration of the analyte in the test sample is determined using a first region of the dose response curve when the measured indicator signal intensity is greater than the reference standard, or the concentration of the analyte in the test sample is determined using a second region of the dose response curve when the measured indicator signal intensity is less than the reference standard, or wherein a third region of the dose response curve is used when the measured indicator signal intensity is the same as the reference standard, the third region providing a range within which the concentration of the analyte falls.

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