血清总胆固醇、总甘油、高密度脂蛋白胆固醇及低密度脂蛋白胆固醇标准物质的研制  

Preparation of serum total cholesterol, total glycerol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol reference materials

作　　者：周伟燕[1] 张传宝[1] 董军[2] 王抒[2] 张江涛[1] 国汉邦[2] 李红霞[2] 胡翠华[1] 赵海舰[1] 张天娇[1] 马嵘[1] 申子瑜[3] 陈文祥[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心,100730 [2]卫生部老年医学研究所 [3]卫生部医院管理研究所

出　　处：《中华检验医学杂志》2013年第11期1013-1017,共5页Chinese Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划资助项目（2011AA02A102,2011AA02A116）;国家自然科学基金资助项目（81201337）;卫生部北京医院博士启动基金资助课题（BJ-2012-32）

摘　　要：目的 研制血清总胆固醇（TC）、总甘油（TTG）、高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）冰冻血清标准物质.方法 实验性基础研究.2008年11月在卫生部北京医院募集年龄20～50岁的健康志愿者28名,男14名,女14名,采集志愿者血清,根据TC的浓度制备3种不同水平的混合血清池.用常规方法进行均匀性和同步稳定性研究.用同位素稀释液相色谱串联质谱（ID-LC/MS/MS）和高效液相色谱（HPLC）法为TC定值,HPLC、ID-LC/MS/MS和同位素稀释气相色谱质谱（ID-GC/MS）法为TTG定值,DCM法和超速离心/HPLC法分别为HDL-C和LDL-C定值.计算各检测项目的不确定度.结果 均匀性数据的方差分析结果显示3种血清池的P值均大于0.05,说明均匀性良好.同步稳定性研究结果显示3种物质在-70 ℃保存至少可稳定1年.3种血清的定值结果（标准值±扩展不确定度,mmoL/L）为：TC分别为6.798±0.075,4.470±0.050,3.221±0.042;TTG分别为1.327±0.024,0.824±0.017,0.659±0.014;HDL-C分别为1.640±0.028,1.652±0.027,1.184±0.022;LDL-C分别为4.577±0.097,2.492±0.072,1.788±0.041.结论 本研究成功研制了TC、TTG、HDL-C和LDL-C冰冻血清标准物质.Objective To prepare serum reference materials for total cholesterol （TC）,total glycerol （TTG）,high-density lipoprotein cholesterol （HDL-C） and low-density lipoprotein cholesterol （LDL-C）.Methods Individual blood samples were collected from 28 healthy donors （14 males and 14females） aged from 20 to 50 years old in November 2008 in Beijing Hospital,and the sera were separated and mixed into 3 serum pools according to cholesterol levels.The materials were tested for homogeneity and stability using routine methods.The methods of isotope dilution liquid chromatography tandem mass spectrometry （ID-LC/MS/MS） and high performance liquid chromatography （HPLC） were used to determine the concentration of TC.HPLC,ID-LC/MS/MS and isotope dilution gas chromatography mass spectrometry （ID-GC/MS） methods were used for TTG.The values of HDL-C and LDL-C were assigned by the designated comparison method and ultracentrifugation/HPLC method,respectively.Results The materials were homogeneous and were tested to be stable for at least 1 year at-70 ℃ using the isochronous stability study.The certified values （reference value ± expanded uncertainty） of the 3 materials were：TC,6.798 ± 0.075,4.470 ± 0.050,3.221 ± 0.042 ; TTG,1.327 ± 0.024,0.824 ± 0.017,0.659 ± 0.014 ; HDL-C,1.640 ± 0.028,1.652 ± 0.027,1.184 ± 0.022 ; LDL-C,4.577 ± 0.097,2.492 ± 0.072,1.788 ± 0.041.Conclusion Certified reference materials for serum TC,TTG,HDL-C and LDL-C have been prepared.

关 键 词：胆固醇 甘油三酯类 胆固醇 HDL 胆固醇 LDL 参考标准 

分 类 号：R446.11[医药卫生—诊断学]