There is a need for inexpensive measurement devices that provide immunological specificity and electrochemical convenience for regulating or achieving fertility. For this purpose, we propose to develop and evaluate a new electrode test strip design that combines the advantages of immunoassay and electrochemical response. The general objective is to develop an electrochemical home immunoassay capable of detecting two different hormones. The Phase I work proved the feasibility of using this dual-analyte, separation-less, solid-phase electrochemical enzyme immunoassay to detect follicle stimulating hormone (FSH) and luteinizing hormone (LH) in urine. Phase II research will develop this immunoassay into a commercial reagentless test strip. The proposed device consists of two major elements: (1) a disposable test strip having an electrical conducting layer containing adsorbed immuno-components, and (2) the reusable electronic components used for data analysis and signal readout. The expected result is an inexpensive enzyme immunoassay electrode for fertility monitoring, based on the principle of coupling the immunochemical reaction to the electrode response. The three researchers submitting this proposal have collaborated successfully to develop prototype enzyme-based biosensor technology which will provide crucial preparation for the development described in this proposal. Multi-analyte immunosensors will provide additional, complimentary information so that these devices will have a distinct commercial advantage.
