脂蛋白相关磷脂酶A2 酶活性法测定试剂的方法学性能评价  

Measurement of Lipoprotein-Associated Phospholipase A2 Enzyme Activity Assay: Evaluation on Performance ofDifferent Methods

作　　者：骆连妹[1] 陈振翅[1] Luo Lianmei;Chen Yizhen(Department of Laboratory,Jiangmen Central Hospital,Jiangmen 529030,Guangdong Province,China)

机构地区：[1]江门市中心医院检验科,广东江门529030

出　　处：《中外医药研究》2023年第31期157-159,共3页JOURNAL OF CHINESE AND FOREIGN MEDICINE AND PHARMACY RESEARCH

摘　　要：目的:评价脂蛋白相关磷脂酶A2(Lp-PLA2)酶活性法试剂的方法学性能,并比较其与化学发光法检测的一致性。方法:依据国家卫生行业标准“临床检验定量测定项目精密度与正确度性能验证”(WS/T 492-2016)文件和临床实验室标准化协会文件要求,评估日立7600-020型全自动生化仪检测Lp-PLA2活性的准确度、精密度、线性范围、可报告范围,检测并计算Lp-PLA2酶活性法的携带污染率;评价Lp-PLA2活性试剂盒在日立7600-020型全自动生化仪的分析性能。临床筛选出符合要求的146例样本,排除溶血、乳糜血及黄疸等影响,分别用酶活性法与化学发光法测定血清Lp-PLA2,以新产业公司Lp-PLA2测定试剂(磁微粒化学发光法)作为参比试剂,进行临床样品比对。结果:Lp-PLA2酶活性法试剂盒配套校准品355.1 U/L,15次连续测定结果平均为348.9 U/L,相对偏差-1.7%;高水平和低水平的批内、批间精密度验证的变异系数均<5%,可报告58.20~18597.87 U/L,Lp-PLA2酶活性法通过5 d的样本检测,均<3%,符合携带污染率的标准。Lp-PLA2酶活性法与化学发光法方法学的相关系数R2=0.973。结论:该Lp-PLA2酶活性法精密度高、线性范围宽、稳定性佳,能满足临床需要,与化学发光法检测的一致性良好。Objective:To evaluate the performance of lipoprotein-associated phospholipase A2(Lp-PLA2)enzyme activity assay and to compare its consistency with chemiluminescent assay.Methods:According to the national health industry standard"Perfor⁃mance verification of precision and correctness of quantitative clinical test items"(WS/T492-2016)and the requirements of the Clinical Laboratory Standardization Association(CLSA),the accuracy,precision,linearity range,and reportable range of the Lp-PLA2 activity assay by Hitachi 7600-020 automatic biochemistry were evaluated,and the carryover contamination rate of the Lp-PLA2 enzyme activity kit in Hitachi 7600-020 was tested and calculated;linear range,and reportable range,and detect and calcu⁃late the carry-over contamination rate of the Lp-PLA2 enzyme activity method;evaluate the analytical performance of the Lp-PLA2 activity kit on the Hitachi Model 7600-020 fully automated biochemistry;clinically screened 146 samples that met the re⁃quirements,excluded the effects of hemolysis,celiac disease and jaundice,and determined serum Lp-PLA2 by the enzyme activi⁃ty method and chemiluminescence method,respectively.The Lp-PLA2 assay reagent(magnetic particle chemiluminescence meth⁃od)of New Industry Company was used as the reference reagent for clinical sample comparison.Results:Lp-PLA2 enzyme activity assay kit matching calibrator 355.1 U/L,the average result of 15 consecutive determinations was 348.9 U/L,with a relative devia⁃tion of-1.7%;the coefficients of variation for both high-level and low-level intra-and inter-batch precision validation were all<5%,and could be reported from 58.20 to 18597.87 U/L,and Lp-PLA2 enzyme activity assay was passed through 5 d of sample with a result fewer than 3%,which meets the criterion of carrying contamination rate.The correlation coefficient of Lp-PLA2 en⁃zyme activity method with chemiluminescence method R2=0.973.Conclusion:The Lp-PLA2 enzyme activity method has high pre⁃cision,wide linear range,good stability,which can meet the

关 键 词：脂蛋白相关磷脂酶A2 酶活性法 化学发光法 方法学性能评价 

分 类 号：R54[医药卫生—心血管疾病]