Epitope Limited

Nanette M Klimkow

Thomas R Thieme

Andrew S Goldstein

Stephen C Piacentini

B Melina Cimler

This invention relates to the use and composition of materials which, when added to oral fluid samples, make such samples suitable for use with microparticle-based immunoassays. In one embodiment, this invention provides a method of reducing false positives in assays for the detection of an analyte in an oral fluid sample. The method involves providing an oral fluid sample combined with a bile acid or salt where the bile acid or salt is present in a concentration sufficient to reduce the rate of occurrence of false positives in said oral fluid based immunoassays.

Reduction of false positives in oral-fluid based immunoassays

A device for obtaining oral fluid containing substances for testing. In one embodiment, the device includes a syringe having a plunger at the end of which an absorbent pad is attached. A test assembly containing the device is also disclosed.

Oral collection device and kit

An improved method for determining the presence of an analyte in an oral fluid sample. A portion of the sample is mixed or contacted with a chromogenic substrate effective to produce a colored product upon reaction with .alpha.-amylase present in the sample. After a selected reaction time, the reaction mixture is inspected to determine the level of such colored product produced. Production of a level of colored product above a selected threshold within the reaction time indicates that an effective volume of undiluted oral fluid sample has been collected which is sufficient to allow detection of the analyte. A device for use in the method is also disclosed.

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Beaverton, OR, United States of America

Nanette M Klimkow