低密度脂蛋白胆固醇测定匀相法试剂评价  

Evaluation of the performance of seven LDL-cholesterol direct reagents used in homogeneous methods

作　　者：国汉邦[1] 李红霞[1] 赵海舰[2] 张传宝[2] 董军[1] 满永[1] 王抒[1] 陈文祥[1,2] 

机构地区：[1]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,北京100730 [2]卫生部北京医院卫生部临床检验中心,北京100730

出　　处：《临床检验杂志》2009年第6期427-430,共4页Chinese Journal of Clinical Laboratory Science

基　　金：国家科技支撑计划资助项目(2007BAI05B09);国家"863"计划资助项目(2006AA020909)

摘　　要：目的评价国内市场7种LDL-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LDL-C试剂与Hitachi 7170A组合构成的7种分析系统为待评常规方法。用比对方法和常规方法同时测定40份新鲜人血清,考察常规方法的精密度、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B、D、E和F测定的平均偏差和医学决定水平上的偏差均<4%,符合美国国家胆固醇教育计划(NCEP)的要求。方法C和G存在明显的特异性问题和校准偏差。所有7种方法测定的总误差均未能达到NCEP的要求,方法A、B、D和E测定的总误差达到美国临床实验室改进修正案(CLIA′88)的要求。结论目前有些LDL-C匀相法试剂的准确性和特异性尚不能满足要求,临床实验室应重视LDL-C试剂的选择和评价。Objective To evaluate the performance of seven LDL-cholesterol reagents used in the homogeneous methods. Methods Forty fresh sera from patients were respectively analyzed by all of the seven homogeneous methods and an uhracenttifugation-HPLC method,which served as a reference. Each homogeneous method was performed by Hitachi 7170A according to the manufacturers＇ instructions. Precision, accuracy, and total errors were evaluated. Results The total CV was 〈 4% for all methods. The average bias and bias at medical decision points of methods B, D, E, and F were 〈 4% , which was in accordance with the NCEP performance guidehne. Significant calibration bias and non-specificity were found in methods C and G. The total errors of all seven methods failed to meet the NCEP performance guidelines. The total errors of methods A, B, D, and E were within ± 30%, which meet the requirements of Clinical Laboratory Amendment, CLIA＇ 88. Conclusions Some homogeneous LDL-C methods had high calibration bias and non-specificity. Clinical laboratories should pay more attention in selecting LDL-cholesterol reagents.

关 键 词：低密度脂蛋白 胆固醇 匀相法 超速离心 高效液相色谱 

分 类 号：R446.1[医药卫生—诊断学]