Self-confirming assay devices

G - Physics – 01 – N

Patent

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Details

G01N 33/558 (2006.01) G01N 33/543 (2006.01)

Patent

CA 2143764

The novel analytical devices and methods of the present invention involve dual pathway devices which provide for the con- firmation of sandwich or competitive assay results. In a self-confirming sandwich assay, the labeled analyte complex becomes im- mobilized within a first pathway at an assay capture site to indicate the presence or amount of an analyte in the test sample. In a second pathway, a confirmatory reagent blocks the binding of the analyte or labeled analyte complex to a confirming assay site, thereby confirming that the presence of label in the assay capture site indicates a positive test sample. In a self-confirming com- petitive assay, a confirmed positive result is one in which the device displays a decrease in signal or no signal at the assay capture site, and the confirming assay site displays a detectable signal.

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