开放式胆固醇测定自动生化分析系统的性能评价  

Evaluation of analytical performance of open automatic biochemistry analysis systems measuring cholesterol

作　　者：张传宝[1] 赵海舰[1] 马嵘[1] 张江涛[1] 王抒 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]老年医学研究所

出　　处：《中华检验医学杂志》2013年第9期801-805,共5页Chinese Journal of Laboratory Medicine

基　　金：国家科技支撑项目（2012BAI37B01）

摘　　要：目的 评价7种开放式胆固醇测定自动生化分析系统的精密度、线性、抗干扰能力、正确度.方法 方法评价研究.选择2012年北京中生、北京柏定、上海复星长征、浙江东瓯、上海科华、四川迈克和日本和光7个厂家的胆固醇氧化酶法测定试剂及其校准品,与日立7170自动生化分析仪组成7种开放式分析系统.按照美国临床和实验室标准化研究院（CLSI）的EP5-A2文件,对这7种系统进行重复性变异系数及实验室内变异系数评价；依据EP6-A文件进行线性评价,线性样本的浓度分别为0、2.07、4.14、6.21、8.28、10.35、12.93、20.69、25.86 mmol/L；按照EP7-A2进行干扰实验,干扰物质包括血红蛋白、维生素C（抗坏血酸）及乳糜；正确度评价采用我国血脂标准化计划的方式进行,样本为参考方法定值为2.88 ～ 5.42 mmol/L的10个浓度的血清盘.结果 7种开放式系统测定低值样本（2.71 mmol/L）时重复性CV分别为0.54％、0.79％、0.56％、0.51％、0.56％、0.48％、0.49％,实验室内CV分别为1.00％、1.06％、1.28％、0.89％、1.08％、1.13％、1.05％；测定高值样本（5.12 mmol/L）时的批内CV分别为0.40％、0.41％、0.51％、0.48％、0.47％、0.45％、0.47％,实验室内CV分别为0.82％、0.69％、1.27％、0.70％、0.70％、1.08％、0.69％；系统A、B、D、F的线性范围上限为12.93 mmol/L,系统C、E、G的线性范围上限为20.69 mmol/L；乳糜浓度1.6％或血红蛋白4 g/L时对7种系统的无明显干扰；在干扰百分偏差的绝对值不超过4％的情况下,7种系统能耐受的维生素C干扰浓度分别为228、215、225、2840、2840、217、2840μmol/L.正确度验证中,7种系统的CV均满足≤3％的要求,偏倚（bias）分别为-0.72％、-1.15％、-2.03％、-2.51％、-0.21％、2.45％、0.78％.结论 7种系统在精密度、线性、正确度、抗干扰能力方面的性能均能满足临床使用的要求；部分产品在抗干扰能力、Objective to evaluate the analytical performance of 7 open automatic biochemistry analysis systems in terms of precision, linearity, anti-interference ability and trueness on determination of cholesterol. Methods Performance verification test. There were 7 open analysis measurement systems composed of 7 kits as well as calibrators from Biosina, Balding, Fosun, Dongou, Kehua, Maker and Wako company respectively, and Hitachi 7170 automatic analyzer were chosen as test systems. The repeatability CV and inter-lab CV were assessed according to Clinical and Laboratory Standards Institute （CLSI） protocol EP5-A2. The linearity range was evaluated on the basis of CLSI EP6-A, the series concentrations of cholesterol were 0, 2. 07, 4. 14, 6. 21, 8.28, 10. 35, 12. 93, 20. 69 and 25.86 mmol/L cholesterol. Hemoglobin, ascorbic acid （vitamin C ） and intralipid were applied as interfere materials in interference testing according to CLSI EP7-A2. The trueness was evaluated on the basis of China national lipids standardization program, the concentrations of 10 samples ranged from 2. 88 to 5.42 mmo]/L measured by reference methods. Results When the low level sample （2. 71 mmol/L） measured, the repeatability CV were 0. 54%, 0. 79%, 0. 56%, 0. 51%, 0. 56%, 0.48% and 0. 49% respectively, intra-lab CV were 1.00%, 1.06%, 1.28%, 0. 89%, 1.08%, 1.13% and 1.05% respectively. When the high level sample （5. 12 mmol/L） measured, the respective repeatability CV were 0. 40%, 0. 41%, 0. 51%, 0. 48%, 0.47%, 0.45% and 0. 47% , the respective intra-lab CV were 0. 82%, 0. 69%, 1.27%, 0.70%, 0. 70%, 1.08% and 0. 69%. The upper limits of linearity range of A, B, D, F was 12. 93 mmol/L and for C, E, G was 20. 69 mmol/L. There is no significant interference on 7 systems with chyle concentration of 1.6% or hemoglobin concentration of 4 g/L. Given the interference bias ≤ 4%, the interference concentrations of ascorbic acid were 228, 215, 225, 2840, 2840, 217 and 2840μmol/L respectively. In trueness verification experiment, the bias of 7

关 键 词：胆固醇 自动化 临床化学试验 

分 类 号：R446.1[医药卫生—诊断学]