不同检测系统血肾素和醛固酮结果一致性及对临床诊断的影响分析

目的分析不同检测系统血肾素及醛固酮浓度结果一致性及对临床诊断的影响。方法收集患者及健康成年人新鲜血浆标本,制备不同浓度肾素及醛固酮样品,经A、B、C或D检测系统检测,分析检测系统间结果的一致性,部分结果与液相色谱-串联质谱法(LC-MS/MS)测定结果再比较分析。健康成年人标本经A和D系统检测,验证其一致性并建立参考区间。结果血肾素和醛固酮浓度在4个系统间的Passing-Bablok分析示Y≠X,相关系数(r)分别为0.901~0.992和0.944~0.976,Bland-Altman分析平均偏差分别为-15.9~0.3μIU/m L和-102.5~104.3 pg/m L,实验室间变异系数分别为1.85%~31.6%和1.98%~28.32%。醛固酮S6~S10与LC-MS/MS结果比较中,r为0.757~0.865,Bland-Altman分析平均偏差为-190.7~-61.3pg/m L。健康成年人结果 Passing-Bablok分析示Y≠X,Bland-Altman分析中95%点均在±1.96s线内。以P2.5~P97.5建立肾素及醛固酮的立位参考区间,A系统为1.95~68.27μIU/m L和28.55~313.75 pg/m L,D系统为3.53~94.82μIU/m L和14.5~311.05pg/m L。结论仅部分检测系统间血肾素及醛固酮浓度结果一致性较好,不同检测系统的结果一致性亟待提高,各实验室应注重建立诊断切点及参考区间。

Analysis of consistency of plasma renin and aldosterone results in different detection systems and their influence on clinical diagnosis

Objective To study the consistency of plasma renin and aldosterone concentration results in different detection systems and analyze their influence on clinical diagnosis. Methods Fresh plasma samples were collected from patients and healthy individuals. The samples of different concentrations were prepared and tested by A,B,C or D testing systems. The consistency of the results among the different detection systems was analyzed. Some of the results were compared with those of liquid chromatography-tandem mass spectrometry( LC-MS/MS). All the measurement results were compared and analyzed. The specimens from healthy adults were tested by A and D systems to verify their consistency,and the reference interval for the tested results was established. Results Passing-Bablok analysis of the measured serum concentrations of renin and aldosterone by the four systems showed that Y≠X,and the correlation coefficients( r) were 0.901 to 0.992 and 0.944 to 0.976. The mean deviations of Bland-Altman analysis were-15.9 to 0.3 μIU/m L and-102.5 to104.3 pg/m L,and the coefficients of variation between laboratories were 1.85% to 31.6% and 1.98% to 28.32%,respectively. In the comparison between the results of aldosterone S6-S10 and LC-MS/MS,r was 0.757 to 0.865,and the mean deviations of Bland-Altman analysis were-190.7 to-61.3 pg/m L. The Passing-Bablok analysis for the results of healthy adults showed that Y≠X,and 95% of the points in Bland-Altman analysis were within ± 1.96 s lines. Based on P2.5 to P97.5,the reference intervals were established as 1.95 to68.27 μIU/m L and 28.55 to 313.75 pg/m L for A system and 3.53 ~ 94.82 μIU/m L and 14.5 ~ 311.05 pg/m L for D system,respectively. Conclusion The consistency of the results between plasma concentrations of renin and aldosterone was fine only in part of testing systems. The consistency of the results from different testing systems needs to be improved urgently. Each laboratory should pay attention to establish its own diagnostic cut-off point and reference interval.