CHOLESTEROL THRESHOLD ASSAY

描述：（改编自研究者摘要。）提议的是 血胆固醇试纸条法的开发。等离子体 在试纸上与细胞分离并被吸收到浸渍的试剂中 血浆受体构件（美国专利4，883，764）。 通过独特和创新的过氧化氢“阈值”分析， 由胆固醇酯酶和氧化酶产生。 阈值 相当于NIH推荐胆固醇临界值的过氧化物量 在无色“清除剂”中反应， 高度敏感的“信号”反应 这消除了彩色背景， 大大增强了视觉解释。禁止使用仪器， 该方法还降低了成本并增加了测试吞吐量。 拟议 装置包括两个试剂垫，一个在胆固醇处产生颜色 浓度为200 mg/dL及以上，另一个浓度为胆固醇 浓度为240 mg/dL及以上。指示两个衬垫上缺少颜色 “理想”，颜色在一个“边界线-高”，和颜色在两个垫“高” 血胆固醇因此，该器械反映并支持指南 国家胆固醇教育计划的患者 通过共识确定和管理衍生的心血管风险 类别. 该产品的目标是医生办公室，筛选和 自我测试市场概念的可行性和产品的可行性 被证明。

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.