Abstract: A sample testing apparatus (100) for use in measuring an analyte in a sample (105) is disclosed. The apparatus includes a sample well (104) for receiving the sample. A solid analyte binding agent (160) is disposed in the sample well. The apparatus further includes a mixing device (156) for mixing the sample with the solid analyte binding agent and a valve (129). The valve is configurable between a closed position for impeding flow of the sample from the sample well and an open position for releasing the sample from the sample well. The apparatus additionally includes a membrane (118) for receiving the sample once released from the sample well, the membrane having a capture reagent (164) adapted to interact with at least one of the analyte, the analyte binding agent, or a complex thereof, to aid in determining the amount of the analyte in the sample.

Abstract: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample are disclosed. The methods involve providing a membrane having an application point, a detection zone, and a contact region, where the contact region is between the application point and the detection zone, and has test particles and internal control particles imbedded within it; contacting the application point with the fluid sample; maintaining the membrane under conditions sufficient to allow fluid to transport analyte by capillary action to the contact region, where the analyte binds to the test particles; further maintaining the membrane under conditions sufficient to allow fluid to transport analyte-bound test particles and internal control particles to the detection zone, where they interact with a detection reagent; and detecting the amount of test particles and the amount of internal control particles in the detection zone.