Morimoto Ryo, Ono Yoshikiyo, Tezuka Yuta, Kudo Masataka, Yamamoto Sachiko, Arai Toshiaki, Gomez-Sanchez Celso E, Sasano Hironobu, Ito Sadayoshi, Satoh Fumitoshi
From the Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine (R.M., Y.O., Y.T., M.K., S.I., F.S.) and Department of Pathology (H.S.), Tohoku University Hospital, Sendai, Miyagi, Japan; Division of Clinical Hypertension, Endocrinology and Metabolism, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan (Y.T., F.S.); Diagnostics Research Laboratories, Diagnostics Development Operations, Diagnostics Division, Wako Pure Chemical Industries, Ltd, Osaka, Japan (S.Y., T.A.); and Division of Endocrinology, G.V. (Sonny) Montgomery VA Medical Center and University of Mississippi Medical Center, Jackson (C.E.G.-S.).
Hypertension. 2017 Aug;70(2):334-341. doi: 10.1161/HYPERTENSIONAHA.117.09078. Epub 2017 Jun 26.
Measurement of plasma aldosterone and renin concentration, or activity, is useful for selecting antihypertensive agents and detecting hyperaldosteronism in hypertensive patients. However, it takes several days to get results when measured by radioimmunoassay and development of more rapid assays has been long expected. We have developed chemiluminescent enzyme immunoassays enabling the simultaneous measurement of both aldosterone and renin concentrations in 10 minutes by a fully automated assay using antibody-immobilized magnetic particles with quick aggregation and dispersion. We performed clinical validation of diagnostic ability of this newly developed assay-based screening of 125 patients with primary aldosteronism from 97 patients with essential hypertension. Results of this novel assay significantly correlated with the results of radioimmunoassay (aldosterone, active renin concentration, and renin activity) and liquid chromatography-tandem mass spectrometry (aldosterone). The analytic sensitivity of this particularly novel active renin assay was 0.1 pg/mL, which was better than that of radioimmunoassay (2.0 pg/mL). The ratio of aldosterone-to-renin concentrations of 6.0 (ng/dL per pg/mL) provided 92.0% sensitivity and 76.3% specificity as a cutoff for differentiating primary aldosteronism from essential hypertension. This novel measurement is expected to be a clinically reliable alternative for conventional radioimmunoassay and to provide better throughput and cost effectiveness in diagnosis of hyperaldosteronism from larger numbers of hypertensive patients in clinical settings.
测量血浆醛固酮和肾素浓度或活性，对于选择抗高血压药物以及检测高血压患者的醛固酮增多症很有用。然而，通过放射免疫测定法测量时需要数天才能得到结果，因此人们长期以来一直期待开发出更快的检测方法。我们已经开发出化学发光酶免疫测定法，通过使用具有快速聚集和分散功能的抗体固定化磁性颗粒的全自动检测方法，能够在10分钟内同时测量醛固酮和肾素浓度。我们对这种新开发的检测方法对来自97例原发性高血压患者的125例原发性醛固酮增多症患者进行诊断能力的临床验证。这种新检测方法的结果与放射免疫测定法（醛固酮、活性肾素浓度和肾素活性）以及液相色谱 - 串联质谱法（醛固酮）的结果显著相关。这种特别新颖的活性肾素检测方法的分析灵敏度为0.1 pg/mL，优于放射免疫测定法（2.0 pg/mL）。醛固酮与肾素浓度之比为6.0（ng/dL 每 pg/mL）时，作为区分原发性醛固酮增多症和原发性高血压的临界值，灵敏度为92.0%，特异性为76.3%。这种新的测量方法有望成为传统放射免疫测定法在临床上可靠的替代方法，并在临床环境中对大量高血压患者进行醛固酮增多症诊断时提供更好的通量和成本效益。
