NATIVE ANALYTE AS REFERENCE IN LATERAL FLOW ASSAYS

摘要

This invention is directed to a lateral flow assay for detecting the presenc e of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect th e presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liqiu id test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.