我国醛固酮检测方法性能和不同类型室间质量评价结果分析

Analysis on the performance of aldosterone testing and the results of EQA in China

目的:通过室间质量评价计划(EQA)对我国醛固酮检测方法的性能进行评价,以改进和提高醛固酮的实验室检测水平。方法:开展全国醛固酮常规EQA和正确度验证EQA。以5个浓度水平的冻干血清作为常规EQA的质评物,将检测结果按照仪器进行分组计算靶值和各组内的变异系数(CV)。以参考方法定值的3个浓度水平的冰冻人血清作为正确度验证EQA的质评物,计算各仪器组同靶值的偏差。结果:常规EQA有272家实验室回报结果,化学发光法占91.6%。放免法和质谱法的组内CV最大,稳健CV分别为14.6%~33.4%和43.5%~53.9%。其他化学发光法的组内CV大多小于10%。正确度验证计划结果显示,质谱法最准确,测定三个质评物的偏差分别为-7.9%、8.9%和-0.7%。其次是索灵,同靶值的偏差分别为58.7%、7.9%和-2.1%。其他化学发光法测定结果偏差较大,且与样本浓度负相关,个别系统偏差可达479%。结论:我国醛固酮实验室检测结果缺乏准确性和可比性,试剂厂商和实验室应重视EQA结果,对醛固酮进行准确溯源,改进并提高醛固酮检测质量。

Objective To evaluate the performance of aldosterone testing in China through the External Quality Assessment(EQA)and improve the testing quality of aldosterone.Methods Two kinds of EQA program for aldosterone were carried out in China,one of which is Routine EQA and the other is Trueness verification scheme.Lyophilized sera with 5 concentration levels were used as quality control of Routine EQA.The results were grouped according to the instrument.Target values and the coefficient of variation(CV)were calculated in each group.Trueness verification scheme was verified by using frozen human sera of 3 concentration levels determined by the reference method,and the bias of each instrument group from the target value was calculated.Results 272 laboratories submitted the testing results,and 91.6%of laboratories used chemiluminescence method.The maximum CV was obtained by radioimmunoassay and liquid chromatography mass spectrometry,and the robust CVs were 14.6%-33.4%and 43.5%-53.9%,respectively.For chemiluminescence methods,the robust group CV was less than 10%.The results of the Trueness verification scheme showed that liquid chromatography mass spectrometry method was the most accurate method,with biases of-7.9%,8.9%and-0.7%for the three quality controls.Diasorin system had the more accurate results deviated from the target by 58.7%,7.9%and-2.1%,respectively.The results of other chemiluminescence methods were negatively correlated with the sample concentration,and one of them with a bias of 479%.Conclusions The accuracy and comparability of aldosterone among laboratories in China are not satisfactory.Reagent manufacturers and laboratories should pay more attention to EQA,with the aldosterone results traceable to SI unit,and improve the test quality of aldosterone.