Interrupted, gravity-promoted, diffused flow chromatography strip testing device and method

Abstract

A device and method for enhancing rapid confirmatory immunological testing ('RCIT') in chromatography strip-type rapid IVD devices useful in, for example, clinical, point-of-care, laboratory or over-the-counter settings. The device drives a flow fluid, primarily under the force of gravity alone, through a first chamber having a porous dam structure to enhance and substantially complete the first affinity binding reaction between a source of mobilizable labeled binding members and an analyte in the fluid. Flow through the dam causes a delay, mixing and trapping of the typically chemically disuniform initial fluid front so that fluid exiting the dam exhibits a more uniformly high degree of first affinity binding and decreased non-affinity binding. Afterward, and without further human interaction, the fluid then flows under the combined, turbulence creating forces of gravity, siphoning, and capillarity, through a second chamber containing a chromatographic strip which captures the labeled analytes in a second affinity binding reaction. By separating the two affinity binding reactions, competition for analytes during each reaction is reduced, and thus accuracy improved.