EXTREMELY RAPID GONADOTROPIN ASSAYS

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Problems of both population control, and diagnosis and treatment of infertility, are of major importance to today's society. Integral to caring for such matters are assay systems for pituitary and gonadal hormones that control reproductive functions. Currently, such assays usually require 2 to 4 days to perform. Recently, by optimizing conventional competitive binding immunoassay techniques for human luteinizing hormone (hLH), we have developed an assay that requires only 2 hours to perform. This assay is currently in routine use in our hospital. We now propose to develop so-called "two-site" noncompetitive assays for human LH, follicle stimulating hormone, and chorionic gonadotropins that can be performed in 15 minutes. Such assays would utilize highly selected monoclonal antibodies labeled with 125I (or later enzyme labeled) as a first reagent. This reagent is used in "great excess," permitting rapid reaction. A second polyclonal antibody directed against multiple other determinants on the hormone is used to separate labeled "bound" monoclonal antibody from "free." Such "short turn-around" assays will permit evaluation of a patient during the initial clinic visit, as well as determination of the ovulatory surge during its occurrence. Such methods would be widely applicable and usable in Obstetrical/Gynecological centers and Endocrine centers treating infertility, and for the control of fertility.