Abbott Laboratories Corporation

James J Donovan

Peter J Tarcha

Martin Wong

Jonathan Staller

Stephen W Worobec

Robin M Pennington

The novel analytical devices and methods of the present invention involve dual pathway devices which provide for the confirmation of sandwich or competitive assay results. In a self-confirming sandwich assay, the labeled analyte complex becomes immobilized 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 competitive 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.

Assay devices for concurrently detecting an analyte and confirming the

An indicator reagent, assay method and test kit for determining the presence or amount of an analyte in a test sample, in which the indicator reagent is formed by attaching an organic polymer latex particle, preferably a colored particle, to a specific binding member. The specific binding member can be adsorbed onto or covalently bound to the organic polymer latex particles. The organic polymer latex particles are readily detected by direct visual observation or can be detected and/or measured by appropriate instrumentation.

Indicator reagents, diagnostic assays and test kits employing organic

The invention relates to assays utilizing microparticle separation. More particularly, the invention relates to microparticle assays used for confirmation of ligands in a biological sample.

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Waukegan, IL, United States of America

James J Donovan