化学发光免疫分析法与液相色谱-串联质谱法在测定肾功能受损患者血浆醛固酮浓度中的比较

Comparison of a chemiluminescence immunoassay with LC-MS/MS in the determination of the plasma aldosterone concentration in patients with impaired renal function.

作者信息

Zeng Qiurong, Li Junlong, Yang Yi, He Yifan, Song Ying, Hu Jinbo, Wang Yue, Li Qifu, Yang Shumin

机构信息

Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Steroids. 2025 Jan;213:109540. doi: 10.1016/j.steroids.2024.109540. Epub 2024 Nov 19.

DOI:10.1016/j.steroids.2024.109540

PMID:39571878

Abstract

PURPOSE

Compared with chemiluminescence immunoassay (CLIA), the quantification of the plasma aldosterone concentration (PAC) via liquid chromatography-tandem mass spectrometry (LC-MS/MS) yields lower values. The extent to which this difference is exacerbated by a reduced glomerular filtration rate (eGFR) is unclear. Therefore, this study aims to assess the impact of renal insufficiency on PAC as measured by CLIA using LC-MS/MS as the reference method.

METHODS

In subjects with a normal or reduced estimated eGFR, the PAC was measured using both LC-MS/MS and two different CLIA kits (Mindray and Liaison).

RESULTS

In total, 383 patients were included in our study. Among them, 71 subjects had eGFRs > 90 (Group one), 79 had eGFRs range from 60 to 89 (Group two), 108 had eGFR range from 30 to 59 (Group three), 51 had eGFRs range from 15 to 29 (Group four), and 74 had eGFRs < 15 (Group five) ml/min per 1.73 m. In all the subjects, PAC as measured by CLIA [68.2 (37.1-122.1) pg/ml for Mindray, 109.0 (68.1-170.0) pg/ml for Liaison] were significantly higher than those measured by LC-MS/MS [47.2 (22.9-88.7) pg/ml]. PAC as measured by CLIA was positively correlated with PAC as measured by LC-MS/MS, but the correlation coefficient gradually decreased as eGFR decreased. Between the LC-MS/MS and Liaison CLIA kits, the difference in PAC values increased with reduced eGFR in groups one through five (76.8 %, 69.2 %, 113.2 %, 152.2 %, and 476.2 % for groups one through five, respectively). However, this difference increased only in Group five with the Mindray CLIA kit (46.4 %, 48.1 %, 45.7 %, 45.0 %, and 74.9 % for groups one through five, respectively).

CONCLUSION

CLIA progressively overestimated PAC as eGFR decreased, particularly with the Liaison method, indicating the need for caution when interpreting these measurements in patients with impaired renal function. In patients with impaired renal function, LC‒MS/MS measurements for PAC are preferable.

摘要

目的

与化学发光免疫分析法（CLIA）相比，通过液相色谱 - 串联质谱法（LC - MS/MS）测定血浆醛固酮浓度（PAC）得到的值较低。肾小球滤过率（eGFR）降低会在多大程度上加剧这种差异尚不清楚。因此，本研究旨在以LC - MS/MS作为参考方法，评估肾功能不全对用CLIA测定的PAC的影响。

方法

在估算的eGFR正常或降低的受试者中，使用LC - MS/MS和两种不同的CLIA试剂盒（迈瑞和利雅路）测量PAC。

结果

本研究共纳入383例患者。其中，71例受试者的eGFR>90（第一组），79例的eGFR范围为60至89（第二组），109例的eGFR范围为30至59（第三组），51例的eGFR范围为15至29（第四组），74例的eGFR<15（第五组）ml/min per 1.73 m²。在所有受试者中，用CLIA测定的PAC[迈瑞为68.2（37.1 - 122.1）pg/ml，利雅路为109.0（68.1 - 170.0）pg/ml]显著高于用LC - MS/MS测定的值[47.2（22.9 - 88.7）pg/ml]。用CLIA测定的PAC与用LC - MS/MS测定的PAC呈正相关，但随着eGFR降低，相关系数逐渐减小。在LC - MS/MS和利雅路CLIA试剂盒之间，第一组至第五组中PAC值的差异随着eGFR降低而增加（第一组至第五组分别为76.8%、69.2%、113.2%、152.2%和476.2%）。然而，使用迈瑞CLIA试剂盒时，仅在第五组差异增加（第一组至第五组分别为46.4%、48.1%、45.7%、45.0%和74.9%）。