新型均相酶法检测sd LDL—C试剂盒的性能评价  

Performance Evaluation of New Homogeneous Enzymatic Reagent Kit for Measurement of Small Dense LDL Cholestero

作　　者：林文涛[1] 李江[3] 孙菲[3] 赵兴波[3] Yasuki Ito Motoko Ohta 鄢盛恺[2] 

机构地区：[1]仙桃市第一人民医院检验科,湖北仙桃433000 [2]中日友好医院检验科,北京100029 [3]首都医科大学附属北京友谊医院检验科,北京100050 [4]日本电化生研株式会社,东京

出　　处：《现代检验医学杂志》2013年第3期129-132,共4页Journal of Modern Laboratory Medicine

摘　　要：目的 评价小而密低密度脂蛋白胆固醇（sd LDL-C）均相酶法检测试剂盒的性能.方法参照CLSI EP文件及其它文献,评估新型sd LDL-C均相酶法液态双试剂检测试剂盒的灵敏度、精密度、线性范围、抗干扰能力和携带污染率,并以密度梯度超速离心法（DUGC）为参比方法,评价新型sd LDL-C均相酶法液态试剂盒的准确度.结果均相法各项精密度及特异度良好,灵敏度可达0.048 mmol/L,低值样本和高值样本的总精密度分别为8.69%和4.64%,测定结果与DUGC法相关性良好（Y=1.065 4X-1.8354）,线性范围上限可达2.634 mmol/L,可以抵抗临床中常见的干扰现象,符合试剂说明书的参数和临床应用的要求.结论新型sd LDL-C均相酶法检测试剂盒各项性能良好,是一种可用于临床常规的快速简便sd LDL-C检测方法.Objective To evaluate the analytical performance of new homogeneous enzymatic method reagent kit for small dense LDL cholesterol （sd LDL-C） assay by using automatic chemistry analyzers capable of accommodating two reagent as- says. Methods Based on CSLI EP documents and other literatures, the sensitivity, precision,linear range, and cross-contami- native rate of reagent kit were analyzed. The accuracy of new homogeneous method was evaluated by comparing with the density gradient ultracentrifugation method （DGUC）. Results All kind of precisions and specificity of new homogeneous method were demonstrated to be good. The sensitivity was 0. 048 mmol/L. The total precisions of low value sample and high value sample were 8. 69% and 4. 64% There was a good relativity between the results of homogeneous method and DGUC （Y=1. 065 4X-1. 8354）. And the upper range of linear was 2. 634 mmol/L. All these parameters met the requirements of the manual of reagent kit and clinical applications. Conclusion All performances of new homogenous reagent kit were good for sd LDL-C assay. This new homogenous test is a direct method for the measurement of sd LDL-C and could be used in clinical routine laboratories.

关 键 词：小而密低密度脂蛋白胆固醇(sd LDL—C) 均相酶法 性能评价 

分 类 号：R446.112[医药卫生—诊断学]