NOVEL STRIP TEST FOR MEASURING OVULATION

用于测量排卵的新型试纸测试

• 批准号: 2536755
• 负责人: Judith L. Erb
• 金额: $ 10万
• 依托单位: IA, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-02-01 至 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2536755
• 关键词: antigen antibody reaction; chromatography; colorimetry; creatinine; diagnosis design /evaluation; estrogen analog; estrone; fiber optics; glucuronides; human tissue; immunologic assay /test; method development; ovulation detection /prediction; urinalysis; urine; antigen antibody reaction; chromatography; colorimetry; creatinine; diagnosis design /evaluation; estrogen analog; estrone; fiber optics; glucuronides; human tissue; immunologic assay /test; method development; ovulation detection /prediction; urinalysis; urine

Measurements of E1-g and Pd-g, urinary metabolites of 17b-estradiol and progesterone, can define the fertile period and determine the occurrence or failure of ovulation. Their measurement currently requires laboratory methods because E1-g is present at ng/m1 levels and because changes in concentrations of E1-g are subtle enough to require semiquantitation. IA, Inc. has obtained very encouraging preliminary data on development of test strips which distinguish ovulatory from non- ovulatory levels of E1-g using an innovative technology which translates binding between antibody and antigen into a visually apparent color change. Unlike tests measuring ng/ml concentrations using enzymes or colloidal gold, these strips will not require instrumentation. We propose to bring this innovative technology to a clear demonstration of feasibility by developing test strips for E1-g which incorporate a means of correcting for variations in urine volume so as to achieve accurate discrimination between the fertile period and the rest of the cycle. Semiquantification will be achieved by comparing the location of the color change on the strip to a concentration scale in the manner of a thermometer. The method will be rapid, simple, and strips more stable than tests employing enzymes. PROPOSED COMMERCIAL APPLICATION Strips detecting occurrence or failure of ovulation, and defining the fertile period will find veterinary applications and will provide an OTC method which will be useful for human family planning and for in vitro fertilization. The technology can be expanded to include a wide range of hormones, drugs, metabolites and toxins, providing physician's office screening, homes testing, veterinary testing, and field testing in place of expensive laboratory procedures.

E1-G和PD-G的测量，17b-雌二醇和 孕酮可以定义肥沃的时期并确定发生 或排卵失败。 他们的测量目前需要 实验室方法是因为E1-G存在于NG/M1级别，并且因为 E1-G浓度的变化足够微妙，需要 半定量。 IA，Inc。获得了非常令人鼓舞的初步 有关测试条开发的数据，该测试条将排卵与非 - 使用创新技术的E1-G排卵水平 抗体和抗原之间的结合成视觉上的颜色 改变。 与使用酶测量Ng/ml浓度的测试不同或 胶体黄金，这些条将不需要仪器。 我们 建议将这项创新技术清楚地证明 通过开发E1-G的测试条来可行性，该条带有一种手段 校正尿量变化以实现准确的 肥沃时期和其余周期之间的歧视。 通过比较 以a的方式将条带的颜色变为浓度量表 温度计。 该方法将是快速，简单的，并且条带更稳定 比采用酶的测试。 拟议的商业应用 条带检测出排卵的发生或失败，并定义 肥沃的时期将找到兽医应用，并将提供OTC 对于人类计划生育和体外的方法 受精。 该技术可以扩展到广泛的范围 荷尔蒙，药物，代谢产物和毒素，提供医师办公室 筛查，房屋测试，兽医测试和现场测试 昂贵的实验室程序。