Establishment of region-, age- and sex-specific reference intervals for aldosterone and renin with sandwich chemiluminescence immunoassays.

IF 3.7 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2025-08-08 DOI:10.1515/cclm-2025-0587

Lin-Lin Cao, Bing Gu, Liqiong Yao, Gang Li, Chunling Wang, Huijun Cui, Ran Xu, Hui Wang

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引用次数: 0

Abstract

Objectives: Accurate measurement of plasma aldosterone (ALD) and renin is important in primary aldosteronism screening and diagnosis. The high variability of ALD and renin due to salt intake, age, and sex, as well as the lack of immunoassay standardization necessitates the establishment of region-, age-, sex- and assay-specific reference intervals (RIs). This study established RIs for ALD and renin using novel sandwich chemiluminescent immunoassays.

Methods: ALD and renin were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). The analytic performances were estimated following CLSI guidelines. A total of 2,281 healthy participants from Beijing, Jiangsu, Henan, Gansu and Guangdong were recruited.

Results: Total imprecision were 1.42-5.09 % for ALD and 1.07-4.11 % for renin. The maximum dilution rates were 50× and 10× for ALD and renin. Interferences of 22 and six interferents for ALD and renin were acceptable. The sandwich ALD immunoassay results highly correlated with LC-MS/MS (r=0.994). The RI of ALD was partitioned based on salt intake, with central 95 % RIs for males of 16.9-185 ng/L (46.8-513 pmol/L) in Guangdong and 26.5-242 ng/L (73.5-671 pmol/L) in other four regions. Females showed an age-dependent decline in ALD levels (RIs in Guangdong: 26.9-442 ng/L [74.6-1,226 pmol/L, 18-40 years], 32.4-326 ng/L [89.9-904 pmol/L, 41-60 years], 21.2-199 ng/L [58.8-552 pmol/L, >60 years], whereas males exhibited no significant change. Renin RIs: females: 3.43-89.2 mU/L (18-40 years), 0.92-67.1 mU/L (41-60 years), 0.66-55 mU/L (>60 years); males: 2.23-95.1 mU/L (≤60 years), 1.71-68.9 mU/L (>60 years).

Conclusions: This is the first study to establish accurate ALD and renin RIs for sandwich immunoassays. Region-, age- and sex-specific RIs were recommended, which will enhance the accuracy of clinical screening and diagnosis of primary aldosteronism.

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用夹心化学发光免疫分析法建立区域、年龄和性别特异性的醛固酮和肾素参考区间。

目的：血浆醛固酮（ALD）和肾素的准确测定对原发性醛固酮增多症的筛查和诊断具有重要意义。由于盐摄入量、年龄和性别的不同，ALD和肾素的高度可变性，以及免疫测定标准化的缺乏，需要建立地区、年龄、性别和测定特异性参考区间（RIs）。本研究利用新型夹心化学发光免疫分析法建立了ALD和肾素的RIs。方法：在全自动化学发光平台（Maglumi X8, Snibe，中国）上检测ALD和肾素。根据CLSI指南估计分析性能。共招募了2281名来自北京、江苏、河南、甘肃和广东的健康参与者。结果：ALD的总不精确性为1.42 ~ 5.09 %，肾素的总不精确性为1.07 ~ 4.11 %。ALD和肾素的最大稀释率分别为50倍和10倍。22种和6种干扰素对ALD和肾素的干扰是可以接受的。夹心ALD免疫分析结果与LC-MS/MS高度相关（r=0.994）。ALD的RI根据盐摄入量划分，广东省男性的中心95% % RIs为16.9 ~ 185 ng/L(46.8 ~ 513 pmol/L)，其他4个地区为26.5 ~ 242 ng/L（73.5 ~ 671 pmol/L）。女性ALD水平呈年龄依赖性下降(广东地区RIs: 26.9-442 ng/L[74.6-1,226 pmol/L， 18-40岁]，32.4-326 ng/L[89.9-904 pmol/L， 41-60岁]，21.2-199 ng/L[58.8-552 pmol/L， 60岁]，而男性无显著变化。肾素RIs：女性：3.43 ~ 89.2 mU/L（18 ~ 40岁），0.92 ~ 67.1 mU/L（41 ~ 60岁），0.66 ~ 55 mU/L（60 ~ 60岁）；男性:2.23 - -95.1 μ/ L(≤60年),1.71 - -68.9 μ/ L(> 60岁)。结论：这是第一个建立准确的ALD和肾素RIs用于夹心免疫测定的研究。推荐地区，年龄和性别特异性RIs，这将提高临床筛查和原发性醛固酮增多症诊断的准确性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!