不同检测系统雌二醇测定结果一致性评价及临床应用

Evaluation of the consistency and clinical application of different detection systems for determining estradiol levels

目的比较不同检测系统血清雌二醇浓度结果相关性及一致性。方法收集2022年6—11月北京航天总医院检验科剩余血清样本49份,采用液相色谱串联质谱法(LC-MS/MS)、雅培i2000SR、罗氏e601、迈瑞CL6000i全自动发光免疫分析仪及其配套试剂(标为A~C)检测49份临床血清样本。参考美国临床和实验室标准化协会EP-15A3方案评价方法的不精密度,LC-MS/MS法为参考系统,系统A、B、C为待评价系统,以Passing-Bablok回归分析两种组合方法的相关性,绘制Bland-Altman图比较医学决定水平处的偏移,通过一致性相关系数(CCC)评估方法之间的一致性。结果3种检测系统的实验室内不精密度均小于说明书标示值。各化学发光法检测系统雌二醇结果与LC-MS/MS结果相关性较好,但仅系统A与LC-MS/MS法相比的斜率95%置信区间(CI)包含1,3种方法截距的95%CI均不包含0。与LC-MS/MS法相比,系统A和系统B的平均相对偏差低于生物学变异最低偏移要求(10.03%)。系统A和B在低值医学决定水平处的偏移不可接受,系统C在所有医学决定水平处的偏移均不可接受。一致性分析表明,系统A与LC-MS/MS的一致性极好,系统B和C与LC-MS/MS的一致性好。结论3种化学发光免疫法检测系统与LC-MS/MS法一致性良好,但在低浓度水平雌二醇的检测偏差较大。提高免疫试剂特异性,完善雌二醇检测溯源体系,提高血清样本雌二醇检测结果的准确性,为临床精准医疗提供帮助。

Objective To compare the correlation and consistency of the serum estradiol concentrations measured by different detection systems.Methods A total of 49 remaining serum samples were collected from June to November 2022 from the Laboratory Department of Beijing Aerospace General Hospital,and these 49 clinical serum samples were tested by liquid chromatography tandem mass spectrometry(LC‒MS/MS),Abbott i2000SR,Roche e601,and Myriad CL6000i fully automated luminescence immunoanalyzer and their accompanying reagents(labeled A-C).Referring to the American Association for Clinical and Laboratory Standardization EP-15A3 for evaluating the imprecision of methods,the LC‒MS/MS method was used as the reference system,and systems A,B and C were the systems to be evaluated.The correlation between the two combined methods was analyzed by Passing‒Bablok regression,and Bland‒Altman plots were plotted to compare the offsets at the medical decision level,which were evaluated by the consistency correlation coefficient(CCC)to assess intermethod agreement.Results The intralaboratory imprecision of the three detection systems was less than the values indicated in the instruction manual.The estradiol results of each chemiluminescence detection system correlated well with the LC‒MS/MS results,but only the 95%confidence interval(CI)of the slope of System A compared with that of the LC‒MS/MS system was 1,and the 95%CI of the intercepts of the three methods did not contain 0.Compared with that of the LC‒MS/MS method,the mean relative bias of Systems A and B was below the minimum bias requirement for biological variation(10.03%).Systems A and B had unacceptable bias at the low-value medical decision level,and System C had unacceptable bias at all medical decision levels.The consistency analysis showed that System A showed excellent consistency with LC‒MS/MS,and Systems B and C showed good consistency with LC‒MS/MS.Conclusions The three chemiluminescence immunoassay detection systems were in good agreement with the LC‒MS/MS method,but the detection bias of estradiol was large at low concentrations.Improving the specificity of immunoreagents and improving the traceability system of estradiol detection will improve the accuracy of estradiol detection results in serum samples and provide help for clinical precision medicine.