CHROMATOGRAPHIC EXCLUSION AGGLUTINATION ASSAY AND METHODS OF USE THEREOF

摘要

The present invention relates to agglutination assays and in particular to chromatographic exclusion assays and methods of use thereof. The present invention includes a novel strategy for determining the presence of one or more analytes on interest in a test sample by using chromatographic exclusion of aggregates of bound detectable specific binding reagents that are accumulated at a particular and non-random location on the test device. In the absence of analytes of interest in the sample under test, the specific detectable binding reagent aggregates are not formed, and hence not excluded from the chromatographic media creating a distinct and readily differentiating event. The present invention is particularly adaptable as a simple test device for detection of diseases or monitoring of treatments at a doctor's office or in the home.