Patent ID: 8614102

Claim:
A system for detecting the presence or quantifying the concentration of an analyte in a biological fluid, comprising: a test device, the device comprising: a housing defining a sample port and a detection window in a surface of the housing; a test strip disposed within the housing, at least a portion of the test strip being associated with the detection window; and a test well disposed within the housing between the sample port and the test strip; wherein the test well defines a flow path from the sample port to the test strip and includes a magnetic mixer and a conjugate, the conjugate comprising a first antibody specific for a first epitope on the analyte and a signal entity; and wherein the test strip comprises two end zones and a trapping zone between the two end zones, the trapping zone having irreversibly bound thereon a second antibody specific for a second epitope on the analyte; and a signal sensing device, the signal sensing device comprising: a processor; a detection head; a movable tray capable of holding the test device and moving the detection window under the detection head; and means for detecting a signal generated by the signal entity.