一个创新的免疫测定准确醛固酮定量:克服低水平的不准确性和肾功能障碍相关的干扰。

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Kaijuan Wang, Hongying Cong, Zhangwei Gao, Xiaojing Gao, Wei Zhang, Xiaocui Shi, Zhou Zhou
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引用次数: 0

摘要

目的:醛固酮的准确定量是筛选和诊断原发性醛固酮增多症(PA)的关键。与液相色谱-串联质谱法(LC-MS/MS)相比,目前的竞争性化学发光免疫测定法(cCLIA)高估了血浆醛固酮浓度(PAC)。然而,LC-MS/MS技术要求高,耗时长,限制了其广泛的临床应用。因此,系统地评估了一种新的两步夹心化学发光免疫分析法(sCLIA),用于准确定量PAC。方法:对新免疫分析法的精密度、准确度、线性范围和最大稀释系数进行综合验证。在一项涉及来自中国7个中心的2,696个样本的多中心研究中,PAC测量采用sCLIA, cCLIA和LC-MS/MS并行进行。该研究特别侧重于评估该方法在低醛固酮浓度和慢性肾脏疾病(CKD)患者中的性能,通过比较不同CKD分期免疫测定和LC-MS/MS结果之间的一致性,研究肾脏损害的潜在干扰。结果:sCLIA在PAC测定中表现出优异的分析性能,但存在分析内不精确(2)。结论:这种新型的sCLIA方法具有优异的分析性能,结合了免疫测定的实用优势和LC-MS/MS的准确性,为临床大规模原发性醛固酮增多症筛查提供了理想的解决方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An innovative immunoassay for accurate aldosterone quantification: overcoming low-level inaccuracy and renal dysfunction-associated interference.

Objectives: Accurate quantification of aldosterone is critical for screening and diagnosing primary aldosteronism (PA). Current competitive chemiluminescence immunoassays (cCLIA) overestimate plasma aldosterone concentration (PAC) compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS). However, LC-MS/MS is technically demanding and time-consuming, limiting its widespread clinical utility. Therefore, a novel two-step sandwich chemiluminescence immunoassay (sCLIA) for accurate quantification of PAC was systematically evaluated.

Methods: Precision, trueness, linear range, and maximum dilution factor of the new immunoassay were comprehensively validated. In a multicenter study involving 2,696 samples from seven Chinese centers, PAC measurements were performed in parallel using sCLIA, cCLIA, and LC-MS/MS. The study specifically focused on evaluating the assay's performance at low aldosterone concentrations and in patients with chronic kidney disease (CKD), investigating potential interference from renal impairment by comparing the consistency between immunoassays and LC-MS/MS results across different CKD stages.

Results: The sCLIA exhibited excellent analytical performance for PAC measurement, with intra-assay imprecision <4.64 % and bias <5.71 % against certificated reference materials. The assay exhibited a wide reportable range (30-100,000 ng/L) with a limit of quantification at 30 ng/L and dilution capability ≥50-fold. Compared to cCLIA, sCLIA showed superior agreement with LC-MS/MS, particularly at low PAC concentrations (<110 ng/L) and in subjects with reduced renal function (eGFR<60 mL/min/1.73 m2).

Conclusions: This novel sCLIA method exhibited excellent analytical performance, combining the practical advantages of immunoassays with LC-MS/MS accuracy, thereby offering an ideal solution for large-scale primary aldosteronism screening in clinical practice.

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来源期刊
Clinical chemistry and laboratory medicine
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!
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