质谱法与免疫测定法检测醛固酮筛查原发性醛固酮增多症：一项前瞻性患者内研究。

Screening for Primary Aldosteronism by Mass Spectrometry Versus Immunoassay Measurements of Aldosterone: A Prospective Within-Patient Study.

机构信息

Department of Medicine III, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.

Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.

出版信息

J Appl Lab Med. 2024 Jul 1;9(4):752-766. doi: 10.1093/jalm/jfae017.

DOI:10.1093/jalm/jfae017

PMID:38532521

Abstract

BACKGROUND

Measurements of aldosterone by mass spectrometry are more accurate and less prone to interferences than immunoassay measurements, and may produce a more accurate aldosterone:renin ratio (ARR) when screening for primary aldosteronism (PA).

METHODS

Differences in diagnostic performance of the ARR using mass spectrometry vs immunoassay measurements of aldosterone were examined in 710 patients screened for PA. PA was confirmed in 153 patients and excluded in 451 others. Disease classifications were not achieved in 106 patients. Areas under receiver-operating characteristic curves (AUROC) and other measures were used to compare diagnostic performance.

RESULTS

Mass spectrometry-based measurements yielded lower plasma aldosterone concentrations than immunoassay measurements. For the ARR based on immunoassay measurements of aldosterone, AUROCs were slightly lower (P = 0.018) than those using mass spectrometry measurements (0.895 vs 0.906). The cutoff for the ARR to reach a sensitivity of 95% was 30 and 21.5 pmol/mU by respective immunoassay and mass spectrometry-based measurements, which corresponded to specificities of 57% for both. With data restricted to patients with unilateral PA, diagnostic sensitivities of 94% with specificities >81% could be achieved at cutoffs of 68 and 52 pmol/mU for respective immunoassay and mass spectrometry measurements.

CONCLUSIONS

Mass spectrometry-based measurements of aldosterone for the ARR provide no clear diagnostic advantage over immunoassay-based measurements. Both approaches offer limited diagnostic accuracy for the ARR as a screening test. One solution is to employ the higher cutoffs to triage patients likely to have unilateral PA for further tests and possible adrenalectomy, while using the lower cutoffs to identify others for targeted medical therapy.German Clinical Trials Register ID: DRKS00017084.

摘要

背景

与免疫测定相比，质谱法测量的醛固酮更准确，干扰更小，当筛查原发性醛固酮增多症（PA）时，可能会产生更准确的醛固酮：肾素比值（ARR）。

方法

在筛查 PA 的 710 名患者中，检查了使用质谱法与免疫测定测量醛固酮的 ARR 的诊断性能差异。在 153 名患者中确诊了 PA，在 451 名其他患者中排除了 PA。在 106 名患者中未达到疾病分类。使用接受者操作特征曲线（AUROC）下的面积和其他措施来比较诊断性能。

结果

基于质谱的测量得出的血浆醛固酮浓度低于免疫测定测量。对于基于免疫测定的醛固酮的 ARR，AUROCs 略低于（P=0.018）基于质谱测量的 AUROCs（0.895 对 0.906）。达到 95%灵敏度的 ARR 截止值分别为 30 和 21.5 pmol/mU 通过各自的免疫测定和基于质谱的测量，特异性分别为 57%。对于单侧 PA 患者的数据限制，在截止值为 68 和 52 pmol/mU 时，免疫测定和质谱测量的诊断敏感性分别为 94%，特异性>81%。