醛固酮实验室检测及其标准化

醛固酮是原发性醛固酮增多症的重要筛查、诊断指标。目前国内外醛固酮实验室检测方法分为2大类:免疫法与质谱法。免疫法包括放射免疫分析法(RIA)与化学发光免疫分析法(CLIA),是当前醛固酮临床检测的主要方法,局限于抗体特异性,免疫法易受交叉反应干扰。质谱法具有高灵敏、高特异的特点,被视为小分子激素类检测"金标准",但前期成本高昂、技术人才要求高,目前醛固酮临床常规质谱检测仍处于初期阶段。免疫法检测醛固酮时不同检测系统间检测结果存在差异,且免疫法与质谱法检测醛固酮结果可比性不佳,准确测定醛固酮并推动醛固酮结果一致可比,是实验室辅助筛查、诊断原发性醛固酮增多症时急需解决的问题,解决该问题有赖于醛固酮测定标准化。目前醛固酮参考溯源体系不完整,缺乏同位素稀释液相色谱串联质谱法(ID-LC/MS/MS)参考测量程序、参考物质与完善的质量保证项目。灵敏、准确的ID-LC/MS/MS能有效降低或避免交叉反应干扰,基于此技术建立参考方法,研制参考物质,完善醛固酮参考溯源体系,有望为临床醛固酮检测提供溯源参考,推进临床醛固酮测定标准化。

Laboratory Measurement of Aldosterone and Its Standardization

Aldosterone is a crucial indicator for the screening and diagnosis of primary aldosteronism(PA). Currently, there is two main kind of aldosterone measurement methods: Immunoassays and ID-LC/MS/MS. Immunoassays including Radioimmunoassay (RIA) and chemiluminescent immunoassay (CLIA) are the most used measurement procedures in laboratories at home and abroad. Limited to its principle of antigen-antibody specific reaction, Immunoassays are easily subject to cross reactions. ID-LC/MS/MS is now regarded as the golden standard for steroids measurement owing to its high sensitivity and specificity, while LC-MS/MS is rarely used in clinical rountine measurement and mostly remains in research field because of its high demand of technologists and costs. Significant differences among different immunoassay measurement procedures and LC-MS/MS methods are found which indicate undesirable standardization/harmonization. To better help the screening and diagnosis of PA in laboratories, accurate measurement of aldosterone and enhancing the standardization of aldosterone measurement results is urgently needed. At present, reference traceability system of aldosterone is lacking and there is an urgent need to conduct them. Sensitive and accurate ID-LC/MS/MS is a promising measurement for providing accurate aldosterone concentration and establishing reference traceability system for clinical diagnosis of hyperaldosteronism.