高密度脂蛋白胆固醇测定匀相法试剂评价  

Evaluation of the performance of 7 homogeneous direct reagents for HDL-cholesterol

作　　者：赵海舰[1] 国汉邦[2] 张传宝[1] 李红霞[2] 董军[2] 王抒[2] 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]卫生部北京医院老年医学研究所、卫生部老年医学重点实验室

出　　处：《中华检验医学杂志》2009年第5期521-525,共5页Chinese Journal of Laboratory Medicine

基　　金：国家科技支撑计划资助项目（2007BA105B09）;国家高技术研究发展计划（863）计划资助项目（2006AA020909）

摘　　要：目的评价国内市场上常见的高密度脂蛋白胆固醇（HDL-C）匀相法试剂的分析质量。方法用超速离心-HPLC法作为比对方法，7种HDL—C试剂和校准物与Hitachi 7170A组合构成的7种分析系统为待评方法。用比对方法和常规方法同时测定40份新鲜人血清，考察匀相法的精密度、偏差和总误差等。结果7种匀相法试剂均具有良好的精密度（CV〈4％）。与超速离心-HPLC法相比，方法A、B和D测定的平均百分偏差（1．33％，4．98％和4．78％）、在医学决定水平上的偏差（〈5％）和总误差（-4．3％～7．8％，-3．2％～12．9％和-0．8％～11．5％）达到美国胆固醇教育计划（National Cholesterol Education Program，NCEP）的要求，具有较好的分析性能。方法C虽然有较好的特异性，但测定结果存在显著负偏差（平均偏差-19．74％），提示校准物的定值偏低。方法E、F和G与UC-HPLC的相关系数R^2〈0．975，40份样本测定的平均绝对百分偏差〉5％，存在一定的准确性和特异性问题。除方法G以外其他6种方法测定的总误差均达到美国临床实验室改进修正案（CLIA88）的要求。结论目前有些HDL—C匀相法试剂的分析质量还存在较大差异，临床实验室应重视HDL—C试剂的选择和评价。Objective To evaluate the analytical performance of 7 homogeneous HDL-eholesterol reagents. Methods An uhraeentrifugation-HPLC method was used as the comparison method. Fourty fresh patient samples were analyzed by homogeneous methods and the comparison method. The homogeneous methods were all performed on a Hitachi 7170A chemistry analyzer according to the manufacturer＇s instructions. Precision, accuracy and total errors were analyzed. Results The homogeneous assays typically demonstrated within run coefficient variance（CV） of 〈 1% , and total CV of 〈 3%. Methods A, B and D showed average bias, bias at the medical decision points and total errors all within the NCEP performance criteria and method C and F unacceptable biases （ - 19.74% and 11.46% ,respeetively） and total errors according to the NCEP criteria. However, all the homogenous methods （A-F） had total errors of 〈 30%, as required by the US Clinical Laboratory Improvement Amendment （ CLIA ） . Conclusions Homogeneous HDL-C assays have been shown to be reasonably precise, but discrepant results have been observed with some of the assays. Clinical laboratories should pay more attention on selecting and validating homogeneous HDL-C reagents.

关 键 词：胆固醇 HDL 指示剂和试剂 色谱法 高效液相 评价研究 

分 类 号：R686[医药卫生—骨科学]