In this application, a proposal to generate a rapid chemiluminescence based immunoassay for urinary luteinizing hormone is described. 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-1,2-dioxetane, (AMPPD), will be investigated. Dephosphorylation of AMPPD with alkaline phosphatase results in a glow of light which 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 a permanent record which will facilitate day to day comparisons, for both patients and their physician. 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 specimen.
