Patent ID: 7939342

Claim:
A diagnostic test kit for detecting the presence or quantity of a test analyte within a test sample, the diagnostic test kit comprising: a lateral flow assay device comprising a porous membrane, the porous membrane defining a detection zone and a calibration zone, wherein a first receptive material is immobilized within the detection zone and a second receptive material is immobilized within the calibration zone; a plurality of assay reagents, wherein the assay reagents comprise a calibration analyte that is disposed on the lateral flow device, wherein the calibration analyte and the test analyte are members of the same protein family, the assay reagents further comprising detection probes and calibration probes disposed on the lateral flow device prior to the application of a test sample to the device, the detection probes being disposed upstream from the detection zone on the lateral flow device, the calibration probes being disposed upstream from the calibration zone on the lateral flow device, the detection probes being conjugated with a first specific binding member configured to preferentially bind to the test analyte and the calibration probes being conjugated with a second specific binding member configured to preferentially bind to the calibration analyte, further wherein the first receptive material is configured to preferentially bind to the test analyte to form a sandwich complex, and the second receptive material is configured to preferentially bind to the calibration analyte to form a sandwich complex; and the detection zone being capable of producing a detection signal and the calibration zone being capable of producing a calibration signal, the intensity of the detection signal, as calibrated by the intensity of the calibration signal, being directly proportional to the concentration of the test analyte within the test sample.