IMMUNOFLUOROMETRIC ASSAY FOR REPRODUCTIVE HORMONES

AN INNOVATIVE NANOSECOND, TIME-RESOLVED FLUORESCENCE DETECTION TECHNOLOGY, WITH THE POTENTIAL FOR SIMULTANEOUSLY MEASURING MULTIPLE ANALYTES IN A SINGLE SAMPLE, WILL BE APPLIED TO THE DEVELOPMENT OF A NOVEL QUANTITATIVE, HIGH-SENSITIVITY IMMUNOFLUORIMETRIC ASSAY SYSTEM FOR REPRODUCTIVE HORMONES. THE PROJECT WILL ENTAIL DEVELOPMENT OF BOTH A PROTOTYPE INSTRUMENT AND PROTOTYPE REAGENTS. IN PHASE I, LUTEINIZING HORMONE (LH) OR HUMAN CHORIONIC GONADOTROPIN (HCG) WILL BE EMPLOYED AS A MODEL HORMONE TO OPTIMIZE ASSAY PERFORMANCE IN TERMS OF SENSITIVITY, SPECIFICITY, SIMPLICITY, SPEED, AND PRECISION AND TO VALIDATE THE FEASIBILITY OF THE APPROACH. IN PHASE II, THE MULTIPLE-ANALYTE CAPABILITIES OF THE APPROACH WILL BE INVESTIGATED, AND THE ANALYTE MENU WILL BE EXPANDED TO INCLUDE ADDITIONAL REPRODUCTIVE HORMONES OF CLINICAL INTEREST. THE IMMUNOASSAY TECHNOLOGY HAS THE POTENTIAL TO NONISOTOPICALLY REPLICATE IN PHYSICIANS' OFFICES THE CAPABILITIES OF THE RADIOIMMUNOASSAY, WHICH GENERALLY CAN BE PERFORMED ONLY IN HOSPITALS OR LARGE REFERENCE LABORATORIES.