CHOLESTEROL THRESHOLD ASSAY

胆固醇阈值测定

• 批准号: 3508710
• 负责人: Mary Gaunt-Kloepfer
• 金额: $ 21.29万
• 依托单位: MICRONIX, INC.
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-01 至 1994-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3508710
• 关键词: blood disorder diagnosis; blood tests; chemical stability; cholesterol; colorimetry; diagnosis design /evaluation; dietary lipid; dyes; hydrogen peroxide; hypercholesterolemia; mass screening; nutrition related tag; oxidoreductase; physical separation; rapid diagnosis; sterol esterase

DESCRIPTION: (Adapted from the investigator's abstract.) Proposed is the development of a test strip method for blood cholesterol. Plasma is separated on the strip from cells and absorbed into a reagent impregnated plasma recipient member (U.S. Patent 4,883,764).Cholesterol is quantified by a unique and innovative "Threshold" assay of hydrogen peroxide, generated by cholesterol esterase and oxidase enzymes. The threshold amounts of peroxide equivalent to the NIH recommended cholesterol cutpoints are reacted in a colorless "Scavenger", the above threshold amounts in a highly sensitive "Signal" reaction. This eliminates color background and greatly enhances visual interpretation. Obviating the use of instruments, the method also reduces costs and increases test throughput. The proposed device comprises two reagent pads, one generating color at cholesterol concentrations of 200 mg/dL and above, the other at cholesterol concentrations of 240 mg/dL and above. Lack of color on both pads indicated "desirable", color on one "borderline-high", and color on both pads "high" blood cholesterols. Thus, the device reflects and supports the guidelines of the NIH National Cholesterol Education Program for patient identification and management by consensus derived cardiovascular risk category. The product is targeted for physician office, screening and self-testing markets. Viability of the concept and product feasibility have been demonstrated.

描述：(改编自调查人员的摘要。)建议的是 血胆固醇试纸法的建立。血浆是 从细胞中分离出来，并吸收到浸渍的试剂中 血浆接受者成员(美国专利4,883,764)。 通过一种独特的、创新的过氧化氢“阈值”测试， 由胆固醇酯酶和氧化物酶产生。门槛 过氧化物量相当于美国国立卫生研究院推荐的胆固醇切点 在一个无色的“清道夫”中反应，以上阈值在一个 高度敏感的“信号”反应。这消除了彩色背景和 极大地增强了视觉解译。不再使用仪器， 该方法还降低了成本并增加了测试吞吐量。建议数 该装置包括两个试剂垫，其中一个在胆固醇下产生颜色 浓度为200毫克/分升或以上，另一个为胆固醇 浓度为240毫克/分升或以上。两个垫子上都没有颜色 “理想”，其中一个的颜色“高”，两个焊盘的颜色都“高”。 血液中的胆固醇。因此，该设备反映并支持指导方针 美国国立卫生研究院全国患者胆固醇教育计划 共识衍生的心血管风险识别和管理 类别。该产品的目标是医生办公室，筛查和 自我测试市场。概念的可行性和产品的可行性都有 已经被证明了。