胰岛素化学发光免疫分析系统正确度和一致性评价的初步研究

A Preliminary Study of the Trueness and Harmonization of Insulin Chemiluminescence Immunoassay Systems

目的拟对胰岛素化学发光免疫分析系统进行正确度和一致性的初步评价和研究。方法在5个全自动化学发光免疫分析系统上同时测试WHO 66/304系列浓度稀释溶液,及20份覆盖0~350μIU/mL浓度范围的单人份血清,参照YY/T1250-2014通过计算相对偏倚(差)进行系统正确度评价,参照CLSI EP30-A对标准物质及其稀释溶液的互换性进行分析。结果除最低浓度(~2μIU/mL)外,计算WHO 66/304系列浓度稀释溶液测试结果相比于理论靶值的相对偏倚,系统A、B、C的大部分结果在临床允许偏倚±18.5%内,系统D、E的最大偏倚分别达到40.2%、39.8%,并且系统D和E的校准品剂量-反应曲线明显偏离于WHO 66/304;各系统间最高偏倚和最低偏倚间差值的平均值为36%。计算人血清样本测试结果相比于5个系统总平均值的相对偏差,5个系统大部分结果的相对偏差不显著偏离临床允许偏差±18.5%;系统间最高偏差和最低偏差间差值的平均值为48%。各个系统组合间的人血清结果Deming回归显示,斜率远偏离1或者截距远偏离0;除A-C系统组合外,WHO 66/304系列浓度稀释溶液在这5个系统间的互换性均较差。结论国际标准物质WHO 66/304用于胰岛素化学发光免疫分析系统的正确度评价有一定的局限性,胰岛素项目的标准化(一致化)水平与临床要求相比仍有一定差距。

Objective This study aims to conduct a preliminary study for the evaluation of the trueness and harmonization of insulin chemiluminescence test systems.Methods WHO 66/304 series concentration dilution solutions,and 20 single human sera covering the concentration range of 0-350μIU/mL were tested simultaneously on five fully automated chemiluminescence immunoassay systems.The system trueness was evaluated by calculating the relative deviation(bias)with reference to YY/T1250-2014,and the commutability of the standard and their dilutions were analyzed with reference to CLSI EP30-A.Results Except for the lowest concentration(-2μIU/mL),the relative bias of the test results of WHO 66/304 series of concentration dilutions compared with the theoretical target values was calculated;Most of the results of systems A,B,and C were within the clinically permissible deviation of±18.5%,and the maximal deviation of systems D and E reached 40.2%and 39.8%,respectively.The calibrator dose-response curves of systems D and E were significantly deviated from WHO 66/304;The mean value of the difference between the highest and lowest deviation among systems was 36%.The relative bias of the test results of human serum samples compared with the total mean of the five systems was calculated,and the relative bias of most of the results of the five systems did not significantly deviate from the clinically permissible bias of±18.5%;The mean value of the difference between the highest and lowest bias among the systems was 48%.Deming regressions of human serum between system combinations showed slopes far from 1 or intercepts far from 0;WHO 66/304 series of concentration dilutions were less commutable between the five systems,except for the A-C system combination.Conclusion The international standard,WHO 66/304,for the trueness evaluation of insulin chemiluminescence immunoassay systems has some limitations,and the standardization(harmonization)of insulin items still needs improvements when compared with clinical requirements.