NOVEL STRIP TEST FOR MEASURING OVULATION

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Measurements of E1-g and Pd-g, urinary metabolites of 17b-estradiol and progesterone, can define the fertile period and determine the occurrence or failure of ovulation. Their measurement currently requires laboratory methods because E1-g is present at ng/m1 levels and because changes in concentrations of E1-g are subtle enough to require semiquantitation. IA, Inc. has obtained very encouraging preliminary data on development of test strips which distinguish ovulatory from non- ovulatory levels of E1-g using an innovative technology which translates binding between antibody and antigen into a visually apparent color change. Unlike tests measuring ng/ml concentrations using enzymes or colloidal gold, these strips will not require instrumentation. We propose to bring this innovative technology to a clear demonstration of feasibility by developing test strips for E1-g which incorporate a means of correcting for variations in urine volume so as to achieve accurate discrimination between the fertile period and the rest of the cycle. Semiquantification will be achieved by comparing the location of the color change on the strip to a concentration scale in the manner of a thermometer. The method will be rapid, simple, and strips more stable than tests employing enzymes. PROPOSED COMMERCIAL APPLICATION Strips detecting occurrence or failure of ovulation, and defining the fertile period will find veterinary applications and will provide an OTC method which will be useful for human family planning and for in vitro fertilization. The technology can be expanded to include a wide range of hormones, drugs, metabolites and toxins, providing physician's office screening, homes testing, veterinary testing, and field testing in place of expensive laboratory procedures.