Disposable device in diagnostic assays

Abstract

A disposable diagnostic assay device and method for its use are provided. The device comprises a sample addition port in fluid communication with at least one main channel. The main channel comprises, in the direction of fluid flow, a main reagent area in fluid communication with an incubation area and a waste area. In fluid communication with the main channel is at least one side reagent channel. The side reagent channels comprise, in the direction of fluid flow, a liquid addition port and a side reagent area in fluid communication with the main channel at a region of the main channel upstream from the incubation area. Agitation means may be included in the at least one of the main and side reagent areas and/or the incubation area. Capillary valves may be located at various positions along the main and side reagent channels upstream from the incubation area, providing for control over fluid flow through the device. Applications in which the device finds use include diagnostic assays employing signal producing systems based on the interactions of specific binding pair members, where optical signals are related to the presence of analyte.