液相色谱-串联质谱法和全自动化学发光免疫法测定血浆醛固酮浓度的一致性评价  

Evaluation of concordance between liquid chromatography-tandem mass spectrometry and fully automated chemiluminescence immunoassay for determination of plasma aldosterone concentration

作　　者：杨春静 续茜桥 宝丽 时正媛 YANG Chunjing;XU Xiqiao;BAO Li;SHI Zhengyuan(Beijing Century Temple Hospital,Affiliated to Capital Medical University,Beijing Key Laboratory of Clinical Rational Drug Use Evaluation,International Cooperative Joint Laboratory of Clinical Rational Drug Use Evaluation,Beijing100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药剂科,临床合理用药评价北京市重点实验室,临床合理用药评价国际合作联合实验室,北京100038

出　　处：《临床检验杂志》2024年第6期406-410,共5页Chinese Journal of Clinical Laboratory Science

基　　金：重大科学仪器设备研发重点专项(2020YFF01014606);首都医科大学附属北京世纪坛医院院基金(2021-C03)。

摘　　要：目的 比较液相色谱-串联质谱法(LC-MS/MS)和全自动化学发光免疫法(CLIA)测定重症监护室(ICU)老年患者血浆醛固酮浓度(PAC)的一致性,并探讨醛固酮(ALD)与血液生物标志物之间的相关性。方法 共纳入41例ICU老年患者,分别采用LC-MS/MS和CLIA两种方法测定PAC,并进行方法学验证和一致性比较。同时,回顾性分析患者的临床资料,对ALD与血液生物标志物之间的相关性进行分析。结果 LC-MS/MS法的线性范围为15~1 500 pg/mL,最低定量限为15 pg/mL。日间、日内精密度均<15%,加标回收率为94%~99%,无明显基质效应。CLIA法与LC-MS/MS法检测的PAC结果呈正相关(r=0.762 7,P<0.01),但2种方法的一致性较差。Deming回归分析得到回归方程为Y=0.969 6X-16.71,斜率为0.970(95%CI:0.890~1.049),截距为-16.71(95%CI:-25.690~-7.728)。Bland-Altman分析显示CLIA法较LC-MS/MS法平均高估21.18 pg/mL(95%CI:-25.89~68.26 pg/mL),偏差为24.02%。在ALD与血液生物标志物间的相关性分析中,ALD与肌红蛋白(Mb)呈显著正相关(r=0.303,P<0.05)。结论 LC-MS/MS法测定ICU老年患者PAC的方法学性能良好。LC-MS/MS法与CLIA法测量结果的一致性欠佳,2种方法不宜在临床上互相替代使用。ALD与Mb之间存在正相关关系,提示ALD可能与心肌损伤有关。Objective To compare the consistency of liquid chromatography-tandem mass spectrometry(LC-MS/MS)and fully automated chemiluminescent immunoassay(CLIA)methods in measuring plasma aldosterone concentration(PAC)in the elderly patients in intensive care unit(ICU)and to explore the correlation between the levels of aldosterone(ALD)and blood biomarkers.Methods A total of 41 elderly ICU patients were included.PAC was measured using both LC-MS/MS and CLIA methods,followed by methodology validation and consistency comparison.Meanwhile,a retrospective analysis of the patients'clinical data was conducted,and the correlations between ALD and blood biomarkers were analyzed.ResultsThe linear range of the LC-MS/MS method was 15 to 1500 pg/mL,with a lower limit of quantification of 15 pg/mL.The inter-day and intra-day precisions were both less than 15%,and the recovery rate was 94%to 99%,with no significant matrix effect.The PAC results detected by CLIA and LC-MS/MS methods were positively correlated(r=0.7627,P<0.01),but the consistency between the two methods was poor.Deming regression analysis yielded the equation Y=0.9696X-16.71,with a slope of 0.970(95%CI:0.890~1.049)and an intercept of-16.71(95%CI:-25.690 to-7.728).Bland-Altman analysis showed that CLIA overestimated PAC by an average of 21.18 pg/mL(95%CI:-25.89 to 68.26 pg/mL)compared to LC-MS/MS,with a bias of 24.02%.In the correlation analysis between ALD and blood biomarkers,ALD showed a significant positive correlation with myoglobin(Mb)(r=0.303,P<0.05).Conclusion The LC-MS/MS method demonstrated good methodological performance in measuring PAC in the elderly patients in ICU.The consistency between LC-MS/MS and CLIA methods was poor,and the two methods should not be used interchangeably in clinical practice.There was a positive correlation between ALD and Mb,suggesting that ALD may be associated with myocardial injury.

关 键 词：老年患者 醛固酮 液相色谱-串联质谱法 化学发光免疫法 肌红蛋白 

分 类 号：R446[医药卫生—诊断学]