Assay Devices and Methods

Abstract

A device for determining an assay result may include a test strip, a light source system, a light detection system, and a processor.

We claim: 
     
         1 . A device for determining an assay result, comprising:
 a test strip comprising at least a first zone and a second zone spaced apart from one another along a flow path defined by the test strip;   a light source system configured to illuminate the first zone and the second zone of the test strip;   a light detection system configured to:
 (a) detect light from the first zone of the test strip when the first zone is illuminated by the light source and output a first signal indicative of light detected from the first zone; 
 (b) detect light from the second zone of the test strip when the second zone is illuminated by the light source and output a second signal indicative of light detected from the second zone; and 
 (c) detect light from at least one of the zones when the respective zone is illuminated by the light source and output a third signal indicative of an amount of an analyte in that zone; and 
   a processor configured to:
 (a) receive the first and second signals and, based at least in part on the first and second signals, determine a result indicative of a time required for a liquid received by the sample receiving zone to flow from the first zone along the flow path to the second zone; and 
 (b) receive the third signal, compare the third signal to a first threshold, compare the third signal to a second threshold, the second threshold being less than the first threshold, and generate an output signal if the third signal exceeds the first threshold or the third signal is less than the second threshold, the output signal indicative of a first result if the third signal exceeds the first threshold, or, alternatively, the output signal indicative of a second result if the third signal is less than the second threshold.