Quidel Corporation

Ya-Chen Hsu

Hans R Boehringer

Allan D Pronovost

Bentley Tam

Jan L Sabran

The efficiency and accuracy of one-step lateral flow assays can be improved by employing more efficient binding between participants in labeling and capture. Thus, in addition to analyte/anti-analyte interactions, specific binding is achieved through members of an irrelevant specific binding pair. Also included within the invention is a format wherein unlabeled competitor for analyte serves as a gatekeeper in the capture zone, competing with analyte for labeled anti-analyte, which analyte will be captured in a detecting portion of a capture zone.

One-step lateral flow assays

An improved one-step immunochromatographic assay which involves the binding of a predetermined amount of analyte to an antibody, enabling the control of the assay sensitivity, is disclosed. The system is especially useful as a controlled sensitivity fecal occult blood assay. Antibodies to a desired analyte, present at a predetermined concentration, are deposited on the sample pad of the reaction unit. The antibody binds analyte present in the sample, up to a threshold amount. Analyte which is present in the sample at a level above the threshold amount proceeds unbound through the sample pad and onto a membrane, where it reacts with an antibody-coated latex and a second, immobilized antibody to generate a positive signal.

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Sunnyvale, CA, United States of America

Ya-Chen Hsu