Lp-PLA2酶法测定试剂盒的临床应用评价

The Evaluation of Clinical Application of the Lp-PLA2 DiagnosticKit-Enzyme Activity Determination

目的验证北京九强金斯尔脂蛋白相关磷脂酶A2(Lp-PLA2)酶法测定试剂盒的性能指标,评价其是否符合临床需求。方法根据WS/T492-2016《临床检测定量测定项目精密度与正确度性能验证》、CNAS-GL037:2019《临床化学定量检验程序性能验证指南》及WST402-2012《临床实验室检验项目参考区间的制定》等文件要求,对北京九强金斯尔Lp-PLA2酶法测定试剂盒的正确度、精密度、线性范围、可报告范围和生物参考区间等性能进行验证,并与上海润鸿Lp-PLA2测定试剂盒进行方法学比对。结果正确度验证中,金斯尔Lp-PLA2酶法测定试剂盒测定厂家工作标准品偏差均小于8%;检测配套高低两水平质控品,每个水平检测的重复性和实验室内精密度的变异系数(CV)均在±2%范围内;在线性区间评价试验中,得到线性回归方程Y=1.0054 X-3.3466,R 2=0.9998。验证线性区间为58.53~1181.07U/L,最大可稀释倍数为64倍,临床可报告上限水平为75588.48U/L。厂家提供的生物参考区间男性:230~728U/L,女性:194~640U/L(18~49岁)和208~698U/L(50~88岁)均通过验证,可适用于临床。此外,与上海润鸿Lp-PLA2测定试剂盒进行方法学比对,其相关性回归分析结果为,Y=1.259 X-23.558,R 2=0.9989。结论北京九强金斯尔Lp-PLA2测定试剂盒的各性能指标均可达到行业标准及厂家声明的要求,与上海润鸿试剂盒检测结果一致性较好,可满足临床需求。

Objective To verify the performance of the enzymatic assay kit for lipoprotein-associated phospholipase A2(Lp-PLA2)of Beijing Jiuqiang Gcell,and to evaluate whether it meets the clinical requirements.Methods According to multiple guidelines,including WS/T492-2016 document(Verification of performance for precision and trueness of quantitative measurements in clinical laboratories),CNAS-GL037:2019(Guidance on the verification of quantitative measurement procedures used in the clinical chemistry)and the profile of WS/T402-2012(Define and determine the reference intervals in clinical laboratory),the performance of Beijing Jiuqiang Gcell Lp-PLA2 enzymatic assay kit for its accuracy,precision,linear range,reportable range and biological reference interval were verified.The performance of this methodology was compared with that of Shanghai Runhong Lp-PLA2 assay kit.Results In the verification of accuracy,the deviation of Gcell Lp-PLA2 enzymatic assay kit in determining the working standards of manufacturers was less than 8%.Two levels of quality control products were tested,and the repeatability of each level and the coefficient of variation(CV)of laboratory precision were within 2%.In the linear interval evaluation test,the linear regression equation was:Y=1.0054 X-3.3466,R 2=0.9998.The linear range was 58.53-1181.07U/L,the maximum dilution factor was 64 times,and the upper limit of clinical reportable level was 75588.48U/L.The biological reference intervals provided by the manufacturer was following:male:230-728U/L,female:194-640U/L(18-49 years old)and 208-698 U/L(50-88 years old).Our results had passed the verification and could be applied to clinic use.In addition,compared with Shanghai Runhong Lp-PLA2 assay kit,the results of correlation regression analysis were:Y=1.259 X-23.558,R 2=0.9989.Conclusion All the performance indexes of Beijing Jiuqiang Gcell Lp-PLA2 assay kit can meet the requirements of industry standards and manufacturers’statements,and the results are in a good agreement with those of Shanghai Runhong assay kit,which can meet the clinical needs.