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Diagnostic test kits employing an internal calibration system

  • US 8,932,878 B2
  • Filed: 03/31/2011
  • Issued: 01/13/2015
  • Est. Priority Date: 03/30/2005
  • Status: Active Grant
First Claim
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1. A method for quantitatively or semi-quantitatively detecting a test analyte within a test sample using a lateral flow device, the device comprising a porous membrane in communication with a calibration analyte, wherein the calibration analyte and the test analyte are distinct yet members of the same protein family, detection probes conjugated with a first specific binding member, and calibration probes conjugated with a second specific binding member, wherein the conjugated detection probes and conjugated calibration probes are applied to a conjugate pad, the porous membrane defining a detection zone on which is immobilized a first receptive material and a calibration zone on which is immobilized a second receptive material, the method comprising:

  • i) contacting the lateral flow device with the test sample, wherein the test analyte mixes with the calibration analyte;

    ii) allowing the text analyte to bind to the detection probes to form test analyte/detection probe complexes and the calibration analyte to bind to the calibration probes to form calibration analyte/calibration probe complexes, wherein the test analyte/detection probe complexes travel to the detection zone and bind to the first receptive material and the calibration analyte calibration complexes travel to the calibration zone and bind to the second receptive material;

    iii) measuring the intensity of a detection signal produced at the detection zone; and

    iv) measuring the intensity of a calibration signal produced at the calibration zone, wherein the amount of the test analyte is directly proportional to the intensity of the detection signal as calibrated by the intensity of the calibration signal.

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