胶乳增强免疫比浊法检测脂蛋白相关磷脂酶A2的性能分析  

Performance analysis of latex enhanced immunoturbidimetry for detection of lipoprotein-associated phospholipase A2

作　　者：涂海霞 韩忠燕 李妍 王安芳 TU Hai-xia;HAN Zhong-yan;LI Yan;WANG An-fang(Center of Pathology and Clinical Laboratory,Sir Run Run Hospital Affiliated to Nanjing Medical University,Nanjing,Jiangsu 211100,China)

机构地区：[1]南京医科大学附属逸夫医院病理与临床检验中心

出　　处：《中国临床研究》2019年第10期1412-1416,共5页Chinese Journal of Clinical Research

基　　金：江苏省高等学校自然科学研究项目(18KJB310006)~~

摘　　要：目的对胶乳增强免疫比浊法测定脂蛋白相关磷脂酶A2(Lp-PLA2)进行实验室性能评估,并对其临床应用进行评价。方法选取排除心脑血管疾病、炎性疾病的、在过去90 d内没有服用降脂药物、年龄18~85岁的健康者354例(男、女各177例),采集其空腹血清和血浆;对配对的血清和EDTA抗凝血浆标本,在室内质控合格的前提下用Roche Cobas8000/c701全自动生化分析仪,采用胶乳增强免疫比浊法测定Lp-PLA2浓度,并对下列参数进行分析:精密度,准确度,线性,参考区间,试剂开封稳定性,试剂批间比较,特异性分析,标本类型差异及标本稳定性。结果结果显示,精密度的平均变异系数≤435%。正确度平均变异系数≤2.31%。检测限平均值为3.4 ng/ml,变异系数为3.89%。不同批次试剂之间相对偏差分别为3.50%和4.56%。一定程度的溶血、脂血、黄疸及类风湿因子(RF)对Lp-PLA2的测定结果无明显干扰。配对血清(含凝胶)和血浆(EDTA抗凝)的结果差异为2.4%(≤3.0%)。在冷藏和冷冻条件下,Lp-PLA2浓度在上述血清和血浆标本中均可稳定30 d。冷藏和冷冻的配对血清(含凝胶)和血浆(EDTA抗凝)可以分别在4个冷藏/复温循环和2个冷冻/解冻循环中保持稳定。结论在Roche Cobas8000/c701上使用胶乳增强免疫比浊法测定Lp-PLA2,表现出准确、精准的性能特征,可以用于临床。Objective To evaluate the laboratory performance of latex enhanced immunoturbidimetry assay for the determination of lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) and its clinical application. Methods The fasting serum and plasma were collected from 354 healthy persons (177 males and 177 females,aged between 18 and 85 years), who were excluded from cardiovascular and inflammatory diseases and did not take lipid-lowering drugs in the past 90 days. For the matched serum and EDTA anticoagulated plasma samples, the concentration of Lp-PLA2 was determined by latex enhanced immunoturbidimetry using the Roche Cobas8000/c701 automatic biochemical analyzer under the condition of indoor quality control. The following parameters were analyzed: precision, accuracy, linearity, reference interval, stability of reagent unsealing, comparison between reagent batches, analysis of specificity, different sample types and sample stability. Results The test results showed that the average coefficient of variation ( CV) of precision was less than or equal to 4. 35%. The average CV of accuracy was less than or equal to 2. 31%. The average detection limit was 3. 4 ng/ml with CV of 3. 89%. The relative deviations between the different batches of reagents were 3. 50% and 4. 56%, respectively. A certain degree of hemolysis, lipid blood, jaundice and rheumatoid factor ( RF) had no obvious interference with the detection results of Lp-PLA2. The difference between paired serum(containing gel) and plasma( EDTA anticoagulant) was 2. 4%(≤3. 0%). Under both cold and frozen storage conditions, Lp-PLA2 levels remained extremely stable for 30 days in the aboue serum and plasma samples. Refrigerated and frozen paired serum ( containing gel) and plasma ( EDTA anticoagulant) remained stable in 4 and 2 refrigeration/resuscitation cycles, respectively. Conclusion Using latex enhanced immunoturbidimetry method by Roche Cobas8000/c701, the detection for Lp-PLA2 is accurate with high precision and can be used in clinical practices.

关 键 词：脂蛋白相关磷脂酶A2 胶乳增强免疫比浊法 血清 血浆 性能验证 变异系数 

分 类 号：R446.LL[医药卫生—诊断学]