高密度和低密度脂蛋白胆固醇测定参考系统现状及有关问题

Current status of the reference system for measurement of serum high- and low-density lipoprotein cholesterol

血清高密度脂蛋白胆固醇(HDL-C)降低和低密度脂蛋白胆固醇(LDL-C)升高是心血管病的重要危险因素;HDL-C和LDL-C测定结果准确、可比,是心血管病防治工作的基本要求.HDL-C和LDL-C准确测定需要可靠的参考系统,包括参考方法、参考物质和标准化计划.美国疾病控制和预防中心(CDC)的参考方法为超速离心/化学沉淀/AK胆固醇测定法,又称β-定量法,此法样本用量大、技术要求高、耗时、低效,限制了其在标准化中的应用.基于相同分离原理的小体积β-定量法样本用量少、操作简便、通量高,在一定程度上解决了CDC参考方法的问题,但仍对样本基质敏感.应用血清参考物质校准或评价常规方法需要考察其互通性问题;应用参考方法评价LDL-C常规方法需要使用新鲜血清.研制具有互通性的参考物质,以及基于超速离心分离和精密胆固醇测定、对样本基质不敏感的参考方法是脂蛋白测定标准化的重要任务.

Decreased serum high-density lipoprotein cholesterol (HDL-C) and increased low-density lipoprotein cholesterol (HDL-C) concentrations are important risk factors for cardiovascular diseases. Achieving accurate and comparable HDL-C and LDL-C results is the primary requirement for the prevention and treatment of cardiovascular diseases, in which reference system including reference method, reference materials and standardization programs are needed. The current reference method for HDL-C and LDL-C measurement is the β-quantification method developed by the United States Center for Disease Control and Prevention (CDC), a multi-step procedure involving ultracentrifugation, chemical precipitation, and cholesterol analysis by CDC reference method. This method uses a large amount of serum and is technically demanding which limited its application in standardization. The reduced volume β-quantification method uses a small volume of serum sample, is simple and high through put and is more applicable. However, both methods are sensitive to serum matrix. Commutability of reference materials should be evaluated when they are used to calibrate routine methods. Fresh (non-frozen) serum samples should be used for a split sample comparison between reference and direct methods. In addition, development of reference measurement procedure based on ultracentrifugation and preparation of commutable reference materials are the important work in lipoprotein standardization.