APOLIPOPROTEIN STANDARDIZATION

高胆固醇血症受试者的鉴定和治疗具有 成为公共卫生优先事项，因为实施了 国家胆固醇教育计划。 此外，越来越多的 有证据表明载脂蛋白水平可以作为重要的预测因子 动脉粥样硬化性疾病 载脂蛋白测定有助于诊断 血脂异常状态，并帮助监测饮食的进展， 和药物干预。 不幸的是，载脂蛋白测量 在没有充分标准化的情况下被广泛使用。 载脂 测量在临床上尚未充分发挥其潜力， 实验室，因为方法问题，标准化不足， 缺乏适当的共同参考材料， 方法. 这反过来又限制了界定适当 临床使用的参考范围。 本提案的目标是专门为了改善 载脂蛋白标准化。 具体目标包括：（1）发展 载脂蛋白A-I和Lp（a）脂蛋白的参考免疫测定; 2）维持 候选参考方法载脂蛋白B ELISA程序，并协助其 可转移到其他实验室; 3）评价主要 载脂蛋白标准品; 4）制备和分发参考血清池 研究临床实验室; 5）评价载脂蛋白参考品 来自工业界、政府或学术界的材料;以及6）评估 商业载脂蛋白方法的准确度和精密度。 参考 载脂蛋白程序需要指定目标值， 二级参考样本池和校准品，并制定 接受新方法。 如果载脂蛋白的改善 标准化实施后，将有可能实现准确性， 载脂蛋白测量，k有助于检测和治疗 血脂异常，并确定有动脉粥样硬化风险的受试者 心血管疾病

The identification and treatment of hypercholesterolemic subjects has become a public health priority as a result of implementation of the National Cholesterol Education Program. Furthermore, there is increasing evidence that apolipoprotein levels can serve as important predictor of atherosclerotic disease. Apolipoprotein measurements aid in the diagnosis of dyslipoproteinemic states and help in monitoring the progress of dietary and drug intervention. Unfortunately, apolipoprotein measurements are being widely used without adequate standardization. Apolipoprotein measurements have not reached their full potential in the clinical laboratory because of problems in methodology, inadequate standardization, the lack of suitable common reference materials and the lack of reference methods. In turn, this has limited the ability to define adequate reference ranges for clinical use. The goals of this proposal are specifically designed to improve apolipoprotein standardization. The specific aims include: 1) develop reference immunoassays for apo A-I, and the Lp(a) lipoprotein; 2) maintain the candidate reference method apo B ELISA procedure and assist in its transferability to other laboratories; 3) evaluate the use of a primary apolipoprotein standards; 4) prepare and distribute reference serum pools to research clinical laboratories; 5) evaluate apolipoprotein reference materials from industry, governments or academia; and 6) evaluate the accuracy and precision of commercial apolipoprotein methods. Reference apolipoprotein procedures are needed for assigning target values to secondary reference pools and calibrators and for setting guidelines for acceptability of new methods. If improvements in apolipoprotein standardization are implemented, it will be possible to achieve accuracy in apolipoprotein measurements,k facilitate detection and treatment of dyslipoproteinemia, and identify subjects at risk for atherosclerotic cardiovascular disease.