Patent ID: 8609401

Claim:
A diagnostic test kit for detecting the presence or absence of a protease within a test sample, the test kit comprising: a lateral flow device that comprises: a sample application zone formed from a first material; a chromatographic medium formed from a second material, wherein the second material is different from the first material and is in fluid communication with the sample application zone, the chromatographic medium defining a discrete reagent zone that is downstream of the sample application zone and a discrete detection zone that is downstream of the reagent zone, the reagent zone containing a substrate that is capable of being cleaved in the presence of the protease to release a chromogenic product, the substrate comprising a peptide bond, the substrate being diffusively immobilized in the reagent zone, the detection zone containing a first reagent that is non-diffusively immobilized in the detection zone, wherein the test sample travels through the chromatographic medium from the sample application zone to the reagent zone and to the detection zone, the first reagent being capable of reacting with the chromogenic product to form a second reagent, the second reagent exhibiting a color that is different than the color of the first reagent; and an absorbent material that is downstream of the detection zone and receives the test sample after flowing through the chromatographic medium.