This project will generate a rapid chemiluminescence-based immunoassay for urinary luteinizing hormone (LH). A prototype system based on a membrane-supported, two-site sandwich immunoassay with an alkaline phosphatase-labeled detector antibody will be developed. Incorporation of 3-(2'adamantane)-4-(3'phosphoryloxy)phenyl-1,2dioxetane (AMPPD) will be investigated. Dephosphorylation of AMPPD with alkaline phosphatase results in a glow of light that will be detected with Polaroid instant film. Peak LH levels will be detected as a white spot on the film, in contrast to black or gray spots imaged when LH concentration is low. The film-based results will provide the user with a permanent record, which will facilitate day-to-day comparisons for both patients and their physicians. Phase II of this program will involve the design and engineering of a disposable unidose device and a prototype of a disposable imaging instrument. This LH assay kit will then be tested with clinically relevant LH-containing specimens.
Anticipated Results:This rapid, easy-to-interpret LH assay will be marketed for at-home determination of fertility.National Institute Of Child Health And Human Development
