Simple Semi-Quantitative Device for Hormones in Body Fluids

Efforts to pinpoint phases of hormonal cycles through daily blood sample analyses have proven excessively expensive and impractical by routine laboratory methods. An attractive alternative is to employ immunochemical test strips to indicate critical ranges of key hormones and metabolites in blood or urine since such techniques offer, in principle, rapid test results at modest cost. Emerald Diagnostics proposes Phase I studies to demonstrate feasibility and sensitivity of a semiquantitative immunochromatographic test strip format which can be devised to measure multiple analytes. The aim of Phase I is to demonstrate feasibility for a single analyte device for the semiquantitative measurement of progesterone in urine. It is anticipated that the studies will demonstrate what the lower limits of sensitivity will be for proprietary technqiues for amplifying the detection system. It is anticipated that the format will provide a measurement range of concentration 10-100 fold above a lower sensitivity limit which can be adjusted to suit the diagnostic problem. The stability of the device will be estimated based upon accelerated stress studies. Most of the anticipated research for Phase I will be carried out at EDI facilities by EDI personnel.