Novel Strip Test for Circulating Hormones

Concentrations of most circulating hormones and their metabolites are too low for existing test strip technologies to measure. Laboratory measurements are based upon immunological binding of these hormones. Color tests utilizing colloidal gold or enzyme mediated color changes have been linked to immunological binding and applied to hormones to yield non-quantitative yes or no tests. These methods cannot provide semi-quantitative determination of the hormone concentration without introducing procedural complicaitons. Innovation Associates proposes to develop test strips for homones utilizing an innovative technology which will permit the binding between antibody and antigen to be translated into a visually apparent color response. Strips will not utilize enzymes or colloidal gold. Semiquantification of analyte will be achieved by comparing the location of the color change on the strip to a concentration scale int he manner of a thermometer. Feasibility of the technology will be demonstrated in Phase I be applying it to the development of test strips for the metabolites of the female reproductive hormone estradiol and progesterone in urine. The method will be rapid (10 minutes or less), simple (requiring only exposure of the strip to a diluted sample), and strips will be more stable than tests employing enzymes.