The measurement evolution enabled more accurate evaluation of aldosterone production in hypertensive patients. However, the cut-off values for novel assays have been not sufficiently validated. The present study was undertaken to validate the novel chemiluminescent enzyme immunoassay for aldosterone in conjunction with other methods. Moreover, we also aimed to establish a new cut-off value for primary aldosteronism in the captopril challenge test using the novel assay. First, we collected 390 plasma samples, in which aldosterone levels measured using liquid chromatography-mass spectrometry ranged between 0.18 and 1346 ng/dL. The novel chemiluminescent enzyme immunoassay showed identical correlation of plasma aldosterone with liquid chromatography-mass spectrometry, in contrast to conventional radioimmunoassay. Further, we enrolled 299 and 39 patients with primary aldosteronism and essential hypertension, respectively. Plasma aldosterone concentrations measured using the novel assay were lower than those measured by radioimmunoassay, which resulted in decreased aldosterone-to-renin ratios. Subsequently, positive results of the captopril challenge test based on radioimmunoassay turned into “negative” based on the novel assay in 45% patients with primary aldosteronism, using the conventional cut-off value (aldosterone-to-renin activity ratio > 20 ng/dL per ng/mL/h). Receiver operating characteristic curve analysis demonstrated that aldosterone-to-renin activity ratios > 8.2 ng/dL per ng/mL/h in the novel assay was compatible with the conventional diagnosis (sensitivity, 0.874; specificity, 0.980). Our study indicates the great measurement accuracy of the novel chemiluminescent enzyme immunoassay for aldosterone, and the importance of measurement-adjusted cut-offs in the diagnosis of primary aldosteronism.

测量的演变使得能够更准确地评估高血压患者醛固酮的产生。然而，新测定的截止值尚未得到充分验证。本研究旨在与其他方法联合验证醛固酮的新型化学发光酶免疫分析法。此外，我们还旨在使用新的检测方法在卡托普利激发试验中建立原发性醛固酮增多症的新临界值。首先，我们收集了 390 份血浆样本，使用液相色谱-质谱法测得的醛固酮水平在 0.18 至 1346 ng/dL 之间。与传统的放射免疫分析相比，新型化学发光酶免疫分析显示血浆醛固酮与液相色谱-质谱法具有相同的相关性。此外，我们分别招募了 299 名原发性醛固酮增多症和 39 名原发性高血压患者。使用新测定法测得的血浆醛固酮浓度低于放射免疫测定法测得的血浆醛固酮浓度，从而导致醛固酮与肾素的比率降低。随后，在 45% 原发性醛固酮增多症患者中，使用传统临界值（醛固酮与肾素活性比值 > 20 ng/dL），基于放射免疫测定法的卡托普利激发试验的阳性结果转为“阴性”。每纳克/毫升/小时）。受试者操作特征曲线分析表明，新测定中醛固酮与肾素活性比值 > 8.2 ng/dL/ng/mL/h 与传统诊断相一致（敏感性，0.874；特异性，0.980）。 我们的研究表明，新型醛固酮化学发光酶免疫分析法具有极高的测量准确性，以及测量调整临界值在原发性醛固酮增多症诊断中的重要性。