A Non-Invasive Test for Predicting the Fertility Window

预测生育窗口的非侵入性测试

• 批准号: 7106701
• 负责人: Wai Tak Law
• 金额: $ 11.34万
• 依托单位: PORTASCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2008-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7106701
• 关键词: artificial membranes; biomarker; clinical research; colorimetry; cost effectiveness; diagnosis design /evaluation; divalent cations; dyes; female; fertility; human subject; ionophores; noninvasive diagnosis; ovulation detection /prediction; ovulation time; polymers; saliva; technology /technique development; urinalysis

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.

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的非侵入性测试条。该试验将基于唾液二价阳离子的半定量比色测定。该测试将易于使用，价格低廉，提供昂贵仪器的准确性，并可用于诊所或家庭环境。PortaScience研究了女性生育期间唾液电解质浓度的变化，并确定存在二价阳离子（特别是Mg++和Ca++）从唾液腺转移。这种阳离子的转移发生在女性的生育期，排卵前三到四天。这种阳离子浓度的下降可以用作预测女性生育期的有效生物标志物。本研究的具体目的是：目的1：选择提供检测250 uM Mg++/Ca++灵敏度的染料底物;目的2：确定用于保护染料底物的稳定剂和膜材料;目的3：构建和评价试纸的性能并定义性能质量标准。美国生育监测的潜在市场为5亿美元。