文章摘要
李敏,孙江漫,孟祥兆,等.不同检测系统雌二醇测定结果一致性评价及临床应用[J].安徽医药,2024,28(6):1112-1115.
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
  
DOI:10.3969/j.issn.1009-6469.2024.06.011
中文关键词: 雌二醇  化学发光法  同位素稀释质谱法  一致性  临床应用
英文关键词: Estradiol  Chemiluminescence  Isotope dilution mass spectrometry  Consistency  Clinical application
基金项目:国家重点研发计划( ZLJC1706-1-1)
作者单位
李敏 北京航天总医院检验科北京 100076 
孙江漫 北京航天总医院检验科北京 100076 
孟祥兆 北京航天总医院检验科北京 100076 
于洪远 北京航天总医院检验科北京 100076 
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中文摘要:
      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。
英文摘要:
      Objective To compare the correlation and consistency of the serum estradiol concentrations measured by different detec tion 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 tandemmass spectrometry (LC MS/MS), Abbott i2000SR, Roche e601, and Myriad CL6000i fully automated luminescence immunoanalyzerand their accompanying reagents (labeled A-C). Referring to the American Association for Clinical and Laboratory Standardization EP15A3 for evaluating the imprecision of methods, the LCMS/MS method was used as the reference system, and systems A, B and C werethe systems to be evaluated. The correlation between the two combined methods was analyzed by PassingBablok regression, and BlandAltman 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 thanthe values indicated in the instruction manual. The estradiol results of each chemiluminescence detection system correlated well withthe LCMS/MS results, but only the 95% confidence interval (CI) of the slope of System A compared with that of the LCMS/MS systemwas 1, and the 95% CI of the intercepts of the three methods did not contain 0. Compared with that of the LCMS/MS method, the meanrelative 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 LCMS/MS, and Systems B and C showed good consistency withLCMS/MS.Conclusions The three chemiluminescence immunoassay detection systems were in good agreement with the LCMS/MSmethod, but the detection bias of estradiol was large at low concentrations. Improving the specificity of immunoreagents and improvingthe traceability system of estradiol detection will improve the accuracy of estradiol detection results in serum samples and provide helpfor clinical precision medicine.
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