现代检验医学杂志2011，Vol.26Issue(4)：10-13,4.DOI:10.3969/j.issn.1671-7414.2011.04.003
血清高、低密度脂蛋白胆固醇标准物质的研究
Preparation of Serum Reference Materials for High- and Low-density Lipoprotein Cholesterol
摘要
Abstract
Objective To prepare serum reference materials for high- and low-density Iipoprotein cholesterol (LDL-C and HDL-C). Methods Individual blood samples were collected from healthy volunteers,sera were separated by centrifugation and mixed into 3 serum pools according to cholesterol and triglyceride levels. Each serum pool was mixed,filter sterilized and aliquoted. The materials were tested for homogeneity and stability. The values of HDL-C and LDL-C were assigned by the designated comparison method and ultracentrifugation /HPLC method , respectively, and the expanded uncertainty was evaluated. The materials were measured by different analytical systems t0 evaluate the commutability. Results ①The materials were tested to be homogeneous (P＞ 0. 05). ②Stability study showed that the materials were stable for at least 1 year at -80℃. ③The certified values (reference value±expanded uncertainty) of the 3 materials for HDL-C were 1. 640 ±0. 028 mmol/L, 1. 652± 0. 027 mmol/L , 1.184±0. 022 mmol/L ,and LDL-C were 4. 577± 0. 097 mmol/L , 2. 492±0. 072 mmol/L,1. 788± 0. 041 mmol/L,respectively.④The results of 16 clinical laboratories showed that the reactivity of the materials was similar to that of fresh serum samples. Conclusion Reference materials for serum HDL-C and LDL-C had been prepared. The materials were homogeneous,stable and HDL-C and LDL-C values were accurately assigned. The materials showed an accepted commutability in routine analytical systems. These materials had been approved to be the Certificate Reference Materials by the General Administration of Quality Supervision, Inspection and Quarantine (GBW 09178,GBW 09179,GBW 09180).关键词
高密度脂蛋白/低密度脂蛋白/胆固醇/标准物质Key words
high density lipoprotein /low density lipoprotein / cholesterol/reference materials分类
医药卫生引用本文复制引用
李红霞,申子瑜,国汉邦,周伟燕,赵海舰,张传宝,董军,王抒,闫颖,陈文祥..血清高、低密度脂蛋白胆固醇标准物质的研究[J].现代检验医学杂志,2011,26(4):10-13,4.基金项目
国家科技支撑计划资助项目(2007BAI05B09) （2007BAI05B09）
国家高技术研究发展计划(863)资助项目(2006AA020909). （863）
