A Non-Invasive Test for Predicting the Fertility Window

描述（由申请人提供）：本研究的目的是开发一种用于预测女性生育窗口期的非侵入性试纸。该试验将基于唾液二价阳离子的半定量比色测定。该检测操作简单，价格低廉，具有昂贵仪器的准确性，可在诊所或家庭环境中使用。PortaScience研究了女性排卵期唾液电解质浓度的变化，并确定了二价阳离子（特别是Mg++和Ca++）从唾液腺转移。这种阳离子的易位发生在女性的排卵期，排卵前三到四天。这种阳离子浓度的下降可以作为一种有效的生物标志物来预测女性的生育期。本研究的具体目的是：目标1：选择一种染料衬底，提供检测250 μ m Mg++/Ca++的灵敏度；目标2：鉴定用于保护染料底物的稳定剂和膜材料；目标3：建立和评估试纸的性能，并定义性能规格。美国生育监测的潜在市场是5亿美元。

DESCRIPTION (provided by applicant): The objective of this research is to develop a non-invasive test strip for the prediction of a women's fertility window. This test will be based on the semi-quantitative colorimetric determination of salivary divalent cations. The test will be simple-to-use, inexpensive, provide the accuracy of costly instruments and can be used in the in the clinic or home setting. PortaScience has investigated changes in concentrations of salivary electrolytes during a female's fertile period and determined that there is a translocation of divalent cations (specifically Mg++ and Ca++) away from the salivary glands. This translocation of cations occurs during a female's fertile period, three to four days prior to ovulation. This drop in concentration of cations can be used as an effective biomarker to predict a women's fertility period. The specific aims of this investigation are: Aim 1: Select a dye substrate that provides the sensitivity to detect 250 uM Mg++/Ca++; Aim 2: Identify stabilizers and membrane material for protecting the dye substrates; and Aim 3: Build and evaluate the performance of test strips and define specifications for performance. The potential US market for fertility monitoring is 500 million dollars.