Sienna Biotech, Inc.

John P Huff

Glen M Ford

Manish S Kochar

James S Steel

Anne J Bodner

Disclosed is an assay for determining the presence of at least one analyte in a sample, which involves the steps of: (a) mixing the sample and predetermined amounts of first test microparticles having disposed thereon a binding molecule which binds a first analyte, and inert reference microparticles to form a reaction mixture, and to allow for the first binding molecule to bind the first analyte; b) counting the numbers of the non-reacted first test microparticles and the reference microparticles; and (c) comparing the number of non-reacted first test microparticles to the reference microparticles to thereby establish a first test value so that the presence of the first analyte in the sample may be determined. In a preferred embodiment, the first test value is compared to a control value for a non-reactive sample, and a change value is calculated therefrom. The presence of additional analytes may be determined by adding second test microparticles having disposed thereon a second binding molecule which binds a second analyte, wherein the second test microparticles are resolvable against the first test microparticles and the reference microparticles in the given counting method, and comparing the number of non-reacted second test microparticles to the reference microparticles to establish a second test value. Also disclosed are compositions and kits containing the microparticles.

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Finksburg, MD, United States of America

John P Huff