A chromatographic lateral-flow assay system for rapid, high sensitivity
method of detecting low levels of ligands in body fluids, with few false
positives and few false negatives. The lateral-flow assay may have a
membrane strip in ribbon form, which increases detection on the order of
2 to 10 fold over the conventional chromatographic specific binding assay
techniques by placing a dried or lyophilized conjugate in colloidal
spheres opposite side of the lateral flow membrane strip. A
chromatographic specific binding assay strip device, comprising: a
laminate strip having a first side and an opposite second side; a
conjugate pad or membrane disposed on said first side of said laminate; a
sample receiving pad or membrane strip and reservoir pad or membrane
disposed on said second side of said laminate; and a detection pad or
membrane strip disposed between the sample pad or membrane and the
reservoir pad or membrane on said second side of said laminate. The assay
system comprises a housing device, such as a test tube or cassettes to
facilitate the mixing of a sample solution with the dried or lyophilized
conjugate, and kits.