尿醛固酮浓度在原发性醛固酮增多症中的筛查价值及质谱法和化学发光法检测的比较

樊静; 张小云; 冯绮玲; 唐菊英; 张少玲; 黎锋; 郭颖; 严励

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尿醛固酮浓度在原发性醛固酮增多症中的筛查价值及质谱法和化学发光法检测的比较

临床研究 | 更新时间：2023-11-01

- 尿醛固酮浓度在原发性醛固酮增多症中的筛查价值及质谱法和化学发光法检测的比较
- Urinary Aldosterone Concentration: Its Value in Primary Aldosteronism Screening and Comparison of a LC-MS/MS Assay and a CLIA Assay for Its Determination
- 中山大学学报（医学科学版） 2020年41卷第4期页码：563-571
- 作者机构：
  
  中山大学孙逸仙纪念医院内分泌科，广东广州 510120
- 作者简介：
  
  樊静，硕士研究生，E-mail：fanj7@mail2.sysu.edu.cn
  张小云,共同第一作者
  张少玲，通信作者，教授，主任医师，博士生导师，E-mail： zhshaol@mail.sysu.edu.cn
- 基金信息：
  
  国家自然科学基金(81970683;81600606);广东省自然科学基金(2018A030313596;2020A151501658)
- DOI：
  中图分类号： R586.9
- 收稿：2020-02-03，
  
  纸质出版：2020-07-15
- 稿件说明：
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樊静,张小云,冯绮玲等.尿醛固酮浓度在原发性醛固酮增多症中的筛查价值及质谱法和化学发光法检测的比较[J].中山大学学报（医学科学版）,2020,41(04):563-571.

FAN Jing,ZHANG Xiao-yun,FENG Qi-ling,et al.Urinary Aldosterone Concentration: Its Value in Primary Aldosteronism Screening and Comparison of a LC-MS/MS Assay and a CLIA Assay for Its Determination[J].Journal of Sun Yat-sen University(Medical Sciences),2020,41(04):563-571.
樊静,张小云,冯绮玲等.尿醛固酮浓度在原发性醛固酮增多症中的筛查价值及质谱法和化学发光法检测的比较[J].中山大学学报（医学科学版）,2020,41(04):563-571. DOI：

FAN Jing,ZHANG Xiao-yun,FENG Qi-ling,et al.Urinary Aldosterone Concentration: Its Value in Primary Aldosteronism Screening and Comparison of a LC-MS/MS Assay and a CLIA Assay for Its Determination[J].Journal of Sun Yat-sen University(Medical Sciences),2020,41(04):563-571. DOI：

摘要

目的

了解尿醛固酮浓度（UAC）对于原发性醛固酮增多症（原醛）的诊断价值；对比研究液相色谱串联质谱法（LC-MS/MS）和化学发光法（CLIA）检测UAC结果的一致性并建立各自的诊断切点。

方法

纳入2018年10月至2019年8月就诊的高血压查因患者133例，其中原醛患者55例（醛固酮瘤30例，特发性醛固酮增生25例），原发性高血压（EH）患者78例。采用CLIA法及LC-MS/MS法平行检测UAC并比较两种方法的相关性、一致性。构建UAC、尿醛固酮/肾素活性比值（UARR）诊断原醛的受试者工作特征（ROC）曲线。以尿钠≥130 mmol/24 h为界建立相对高尿钠组（

=51），比较不同钠盐摄入情况对于诊断价值的影响。

结果

①CLIA法与LC-MS/MS法检测的UAC结果呈正相关（

=0.69，

＜0.01），Bland-Altman法分析提示两种方法所测UAC一致性欠佳。②UAC

CLIA

及UAC

LC-MS/MS

诊断原醛的价值均不及ARR。而UAC

CLIA

及UAC

LC-MS/MS

的诊断价值无统计学差异。UAC

CLIA

的ROC曲线下面积（AUC）为0.739

切点为5.1 μg/24 h。UAC

LC-MS/MS

的AUC为0.659，切点为11.6 μg/24 h。ARR的AUC为0.943，最佳切点为23.2 ng·dL

-1

/（μg·L

-1

·h

-1

）。③UARR对于原醛的诊断价值较高，与ARR相当。UARR

CLIA

的AUC为0.924，诊断切点为1.75 μg·24 h

-1

/（μg·L

-1

·h

-1

）。UARR

LC-MS/MS

的AUC为0.906，诊断切点为4.63 μg·24 h

-1

/（μg·L

-1

·h

-1

）。④相对高尿钠亚组UAC

LC-MS/MS

的AUC为0.708，切点为14.9 μg/24 h。诊断价值较分组前并不能进一步提高。

结论

单一指标UAC诊断原醛的价值较低，但UARR诊断原醛的诊断价值显著提高，与ARR相当。UAC

LC-MS/MS

、UAC

CLIA

诊断切点分别为11.6 μg/24 h、5.1 μg/24 h，UARR

LC-MS/MS

、UARR

CLIA

的诊断切点分别为4.63 μg·24h

-1

/（μg·L

-1

·h

-1

）、1.75 μg·24 h

-1

/（μg·L

-1

·h

-1

）。另LC-MS/MS法与CLIA法检测UAC一致性欠佳，提示临床上使用不同检测方法需要采用不同参考值范围。

Abstract

Objective

To explore the clinical value of urinary aldosterone concentration (UAC) in primary aldosteronism (PA) screening and to evaluate the consistency of the two methods

liquid chromatography tandem mass spectrometry (LC-MS/MS) and chemiluminescence immunosorbent assay (CLIA)

for determining UAC.

Methods

Among the 133 patients with suspected PA enrolled from October 2018 to August 2019

55 were diagnosed with PA (30 with aldosterone-producing adenoma and 25 with bilateral idiopathic hyperplasia) and 78 with essential hypertension (EH). Parallel determination of UAC was done with LC-MS/MS and CLIA assays on all subjects

then we compared the two methods and evaluated their correlation and consistency. Reciever operating characteristic (ROC) analysis was applied to assess the diagnostic accuracies

area under the curve (AUC) and cutoff values of UAC

plasma aldosterone concentration (PAC)

random aldosterone to renin ratio (ARR) and urine aldosterone to renin ratio (UARR). Furthermore

ROC analysis of high urine sodium subgroup (urine sodium≥130 mmol/24h) was performed to evaluate the impact of sodium intake on PA screening.

Results

①UAC

CLIA

and UAC

LC-MS/MS

were positively correlated (

=0.69

0.001). Bland-Altman analysis showed poor consistency between CLIA and LC-MS/MS. ②The diagnostic efficiency of UAC and PAC in PA screening was equivalent (

0.05)

while ARR was more efficient than UAC and PAC (

0.0001). AUC of UAC

CLIA

UAC

LC-MS/MS

PAC and ARR was 0.739

0.659

0.723

0.943

respectively. The cutoff values for them were 5.1 μg/24 h

11.6 μg/24 h

27.6 ng/dL and 23.2 ng·dL

-1

/(μg·L

-1

·h

-1

)

respectively. ③Both UARR

CLIA

and UARR

LC-MS/MS

performed as well as ARR in PA screening. AUC of UARR

CLIA

was 0.924 at the cutoff value of 1.75 μg·24h

-1

/(μg·L

-1

·h

-1

). While AUC of UARR

LC-MS/MS

was 0.906 at the cutoff value of 4.63 μg·24h

-1

/(μg·L

-1

·h

-1

). AUC of UAC

LC-MS/MS

in high urine sodium subgroup was 0.708 at the cutoff of 14.9 μg/24 h. ④The diagnostic efficiency of UAC made no difference after sodium intake increased to 130 mmol/24 h or higher.

Conclusion

UAC alone is of little clinical value compared to ARR in PA screening and can serve as a supplementary indicator currently. But UARR

a combintion of UAC and plasma renin activity (PRA)

is as valuable as ARR for screening PA. The optimal cutoff values of UAC

LC-MS/MS

and UAC

CLIA

are 11.6 μg/24 h

5.1 μg/24 h

respectively. The optimal cutoff values of UARR

LC-MS/MS

and UARR

CLIA

are 4.63 μg·24 h

-1

/(μg·L

-1

·h

-1

) and 1.75 μg·24 h

-1

/(μg·L

-1

·h

-1

)

respectively. Besides

significant bias of UAC observed in CLIA and LC-MS/MS results indicates that appropriate definition of cutoff value and reference range for each method are mandatory.

关键词

Keywords

references

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