The OVEIA Dual Analyte assay--a new method for profiling the menstrual cycle

For the clinical management of the sub-fertile couple there is a need for better methods of monitoring ovarian function in the woman at an early stage of the investigation. This chapter describes the novel OVEIA DUAL ANALYTE assay, which has been designed for this purpose and has recently been made commercially available by Boots-Celltech Diagnostics Limited. The OVEIA DUAL ANALYTE assay is a non-radioactive, laboratory-based, colorimetric method which directly measures an index of the relative levels of the ovarian steroid metabolites, estrone glucuronide (E13G) and pregnanediol glucuronide (PD3G) in urine. The microwell ELISA format of the method allows ready generation of quantitative cyclical profiles of the E13G/PD3G index, thus providing a direct measure of ovarian function from one test. Data are presented which indicate that the OVEIA DUAL ANALYTE assay may prove to be a useful tool in the initial screening and subsequent management of women who present with sub-fertility. The potential of the DUAL ANALYTE principle for detection of the fertile period, in the context of natural family planning programs, is also discussed.