An innovative immunoassay is being developed to determine ovulation time by monitoring luteinizing hormone (LH). The test will be more stable and less expensive than currently popular quantitative methods such as RIA or ELISA. During Phase I, a sensitivity of 8 mIU/ml (pre-ovulatory LH levels in serum are 10-25 mIU/ml) was achieved for the quantitative assay. This exquisite sensitivity will provide a sound basis for further improvement and stream- lining of the procedure for the quantitative assay. A dipstick version is also under development, which will provide the same advantages for a product to serve the doctor's office and for home use. Preliminary results on the dipstick during Phase I indicate the coating technology is easily transferrable. Each LH assay will be tailored for its particular market nitch; vis., clinical and home use of these products for the management of infertility. Proof-of-performance studies for both methods will establish that these novel assays will out-perform existing commercial products.
