{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T09:24:28Z","timestamp":1788168268371,"version":"build-2803163510"},"reference-count":35,"publisher":"Walter de Gruyter GmbH","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"Abstract<\/jats:title>\n \n Objectives<\/jats:title>\n To compare 24-h urinary excretion of aldosterone (24-h UEA) measured by competitive chemiluminescent immunoassay (cCLIA) and sandwich chemiluminescent immunoassay (sCLIA) with liquid chromatography-tandem mass spectrometry (LC-MS\/MS), and to evaluate a direct renin concentration (DRC)-stratified interpretive strategy for primary aldosteronism\u00a0(PA).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We prospectively enrolled 705 hypertensive inpatients, including 105 with PA and 600 with essential hypertension. 24-h UEA was measured by cCLIA, sCLIA, and LC-MS\/MS, and DRC was measured by CLIA. Method agreement was assessed using Passing\u2013Bablok regression and Bland\u2013Altman analysis. Diagnostic performance was evaluated using receiver operating characteristic (ROC), with internal validation by 1,000\u00a0outcome-stratified bootstrap resamples.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Both CLIAs correlated strongly with LC-MS\/MS (Spearman r=0.946 for cCLIA and 0.950 for sCLIA). Overall areas under the curve (AUCs) were 0.809, 0.814, and 0.812 for cCLIA, sCLIA, and LC-MS\/MS, respectively, with no statistically significant differences among the methods. A DRC cutoff of 8.1\u202fmU\/L was used to define low-DRC (\u22648.1\u202fmU\/L) and high-DRC (>8.1\u202fmU\/L) subgroups. In the low-DRC subgroup, AUCs were 0.880, 0.879, and 0.881; in the high-DRC subgroup, they were 0.871, 0.878, and 0.859, respectively. Optimism-corrected AUCs remained close to the original estimates. Method-specific high-sensitivity and high-specificity thresholds were used to construct an exploratory DRC-stratified interpretive strategy.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n CLIA-based 24-h UEA measurements showed strong correlation and small mean bias with LC-MS\/MS and similar diagnostic discrimination in this cohort. DRC stratification may support method-specific interpretation of 24-h UEA, but the proposed thresholds require prospective external validation before clinical implementation.<\/jats:p>\n <\/jats:sec>","DOI":"10.1515\/cclm-2026-0865","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T09:11:29Z","timestamp":1788167489000},"source":"Crossref","is-referenced-by-count":0,"title":["A diagnostic strategy for primary aldosteronism diagnosis based on urinary aldosterone assay"],"prefix":"10.1515","author":[{"given":"Zhangwei","family":"Gao","sequence":"first","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaojing","family":"Gao","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongying","family":"Cong","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaocui","family":"Shi","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutao","family":"Liu","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhou","family":"Zhou","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7105-8563","authenticated-orcid":false,"given":"Kaijuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College\/National Center for Cardiovascular Diseases , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"key":"2026083109112459317_j_cclm-2026-0865_ref_001","doi-asserted-by":"crossref","unstructured":"Rossi, GP. A comprehensive review of the clinical aspects of primary aldosteronism. Nat Rev Endocrinol 2011;7:485\u201395. https:\/\/doi.org\/10.1038\/nrendo.2011.76.","DOI":"10.1038\/nrendo.2011.76"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_002","doi-asserted-by":"crossref","unstructured":"Bioletto, F, Bollati, M, Lopez, C, Arata, S, Procopio, M, Ponzetto, F, et al.. Primary aldosteronism and resistant hypertension: a pathophysiological insight. Int J Mol Sci 2022;23:4803. https:\/\/doi.org\/10.3390\/ijms23094803.","DOI":"10.3390\/ijms23094803"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_003","doi-asserted-by":"crossref","unstructured":"Monticone, S, Burrello, J, Tizzani, D, Bertello, C, Viola, A, Buffolo, F, et al.. Prevalence and clinical manifestations of primary aldosteronism encountered in primary care practice. J\u00a0Am Coll Cardiol 2017;69:1811\u201320. https:\/\/doi.org\/10.1016\/j.jacc.2017.01.052.","DOI":"10.1016\/j.jacc.2017.01.052"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_004","doi-asserted-by":"crossref","unstructured":"Libianto, R, Russell, GM, Stowasser, M, Gwini, SM, Nuttall, P, Shen, J, et al.. Detecting primary aldosteronism in Australian primary care: a prospective study. Med J Aust 2022;216:408\u201312. https:\/\/doi.org\/10.5694\/mja2.51438.","DOI":"10.5694\/mja2.51438"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_005","doi-asserted-by":"crossref","unstructured":"K\u00e4yser, SC, Dekkers, T, Groenewoud, HJ, van der Wilt, GJ, Carel Bakx, J, van der Wel, MC, et al.. Study heterogeneity and estimation of prevalence of primary aldosteronism: a systematic review and meta-regression analysis. J\u00a0Clin Endocrinol Metab 2016;101:2826\u201335. https:\/\/doi.org\/10.1210\/jc.2016-1472.","DOI":"10.1210\/jc.2016-1472"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_006","doi-asserted-by":"crossref","unstructured":"Buffolo, F, Tetti, M, Mulatero, P, Monticone, S. Aldosterone as a mediator of cardiovascular damage. Hypertension 2022;79:1899\u2013911. https:\/\/doi.org\/10.1161\/hypertensionaha.122.17964.","DOI":"10.1161\/HYPERTENSIONAHA.122.17964"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_007","doi-asserted-by":"crossref","unstructured":"Zennaro, MC, Boulkroun, S, Fernandes-Rosa, FL. Pathogenesis and treatment of primary aldosteronism. Nat Rev Endocrinol 2020;16:578\u201389. https:\/\/doi.org\/10.1038\/s41574-020-0382-4.","DOI":"10.1038\/s41574-020-0382-4"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_008","doi-asserted-by":"crossref","unstructured":"Brown, JM, Siddiqui, M, Calhoun, DA, Carey, RM, Hopkins, PN, Williams, GH, et al.. The unrecognized prevalence of primary aldosteronism: a cross-sectional study. Ann Intern Med 2020;173:10\u201320. https:\/\/doi.org\/10.7326\/m20-0065.","DOI":"10.7326\/M20-0065"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_009","doi-asserted-by":"crossref","unstructured":"Rossi, GP, Rossi, FB, Guarnieri, C, Rossitto, G, Seccia, TM. Clinical management of primary aldosteronism: an update. Hypertension 2024;81:1845\u201356. https:\/\/doi.org\/10.1161\/hypertensionaha.124.22642.","DOI":"10.1161\/HYPERTENSIONAHA.124.22642"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_010","doi-asserted-by":"crossref","unstructured":"Sechi, LA, Colussi, GL, Novello, M, Uzzau, A, Catena, C. Mineralocorticoid receptor antagonists and clinical outcomes in primary aldosteronism: as good as surgery? Horm Metab Res 2015;47:1000\u20136. https:\/\/doi.org\/10.1055\/s-0035-1565128.","DOI":"10.1055\/s-0035-1565128"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_011","doi-asserted-by":"crossref","unstructured":"Goto, Y, Kitamoto, T, Tanaka, S, Maruo, M, Sugawara, S, Chiba, K, et al.. Feasibility of single-port laparoscopic partial adrenalectomy with selective adrenal venous sampling and high-resolution ultrasound for unilateral aldosterone-producing adenomas. Surgery 2023;174:234\u201340. https:\/\/doi.org\/10.1016\/j.surg.2023.04.010.","DOI":"10.1016\/j.surg.2023.04.010"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_012","doi-asserted-by":"crossref","unstructured":"Liu, YY, King, J, Kline, GA, Padwal, RS, Pasieka, JL, Chen, G, et al.. Outcomes of a specialized clinic on rates of investigation and treatment of primary aldosteronism. 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Determination of serum aldosterone by liquid chromatography and tandem mass spectrometry: a liquid-liquid extraction method for the ABSCIEX API-5000 mass spectrometry system. J\u00a0Clin Pathol 2012;65:457\u201362. https:\/\/doi.org\/10.1136\/jclinpath-2011-200564.","DOI":"10.1136\/jclinpath-2011-200564"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_022","unstructured":"Kulle, AE, Welzel, M, Holterhus, PM, Riepe, FG. Principles and clinical applications of liquid chromatography\u2013tandem mass spectrometry for the determination of adrenal and gonadal steroid hormones. J\u00a0Endocrinol Invest 2011;34:702\u20138. https:\/\/doi.org\/10.3275\/7843."},{"key":"2026083109112459317_j_cclm-2026-0865_ref_023","doi-asserted-by":"crossref","unstructured":"Tetti, M, Burrello, J, Goi, J, Parasiliti-Caprino, M, Gioiello, G, Settanni, F, et al.. Diagnostic accuracy of aldosterone and renin measurement by chemiluminescence for screening of patients with primary aldosteronism. Int J Mol Sci 2024;25:8453. https:\/\/doi.org\/10.3390\/ijms25158453.","DOI":"10.3390\/ijms25158453"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_024","doi-asserted-by":"crossref","unstructured":"Debeljak, \u017d, Markovi\u0107, I, Pavela, J, Luki\u0107, I, Mandi\u0107, D, Mandi\u0107, S, et al.. Analytical bias of automated immunoassays for six serum steroid hormones assessed by LC-MS\/MS. Biochem Med 2020;30:030701. https:\/\/doi.org\/10.11613\/BM.2020.030701.","DOI":"10.11613\/BM.2020.030701"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_025","doi-asserted-by":"crossref","unstructured":"Wang, K, Cong, H, Gao, Z, Gao, X, Zhang, W, Shi, X, et al.. An innovative immunoassay for accurate aldosterone quantification: overcoming low-level inaccuracy and renal dysfunction-associated interference. Clin Chem Lab Med 2025;63:2477\u201384. https:\/\/doi.org\/10.1515\/cclm-2025-0743.","DOI":"10.1515\/cclm-2025-0743"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_026","doi-asserted-by":"crossref","unstructured":"Teruyama, K, Naruse, M, Tsuiki, M, Kobayashi, H. Novel chemiluminescent immunoassay to measure plasma aldosterone and plasma active renin concentrations for the diagnosis of primary aldosteronism. J\u00a0Hum Hypertens 2022;36:77\u201385. https:\/\/doi.org\/10.1038\/s41371-020-00465-5.","DOI":"10.1038\/s41371-020-00465-5"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_027","doi-asserted-by":"crossref","unstructured":"Yin, Y, Ma, C, Yu, S, Liu, W, Wang, D, You, T, et al.. Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone. Clin Chem Lab Med 2019;58:95\u2013102. https:\/\/doi.org\/10.1515\/cclm-2019-0706.","DOI":"10.1515\/cclm-2019-0706"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_028","doi-asserted-by":"crossref","unstructured":"Wijbenga-van der Kooi, I, van Faassen, M, Kerstens, M, Kema, IP, Vos, MJ. Urinary aldosterone and tetrahydroaldosterone by LC-MS\/MS with enzymatic hydrolysis: validation and age-stratified reference intervals. Clin Chem Lab Med 2026;64:1614\u201323.","DOI":"10.1515\/cclm-2025-1679"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_029","unstructured":"Burtis, CA, Bruns, DE. Tietz fundamentals of clinical chemistry and molecular diagnostics, 7th ed. Amsterdam: Elsevier; 2014."},{"key":"2026083109112459317_j_cclm-2026-0865_ref_030","unstructured":"Clinical and Laboratory Standards Institute. Liquid chromatography-mass spectrometry methods, 2nd ed. CLSI guideline C62. 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Best Pract Res Clin Endocrinol Metab 2013;27:663\u201374. https:\/\/doi.org\/10.1016\/j.beem.2013.05.015.","DOI":"10.1016\/j.beem.2013.05.015"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_034","doi-asserted-by":"crossref","unstructured":"Zhou, W, Deng, Y, Ma, W, Zhao, H, Wang, K, Zhang, Q, et al.. Insight into the status of plasma renin and aldosterone measurement: findings from 526 clinical laboratories in China. Clin Chem Lab Med 2024;62:2233\u201341. https:\/\/doi.org\/10.1515\/cclm-2024-0373.","DOI":"10.1515\/cclm-2024-0373"},{"key":"2026083109112459317_j_cclm-2026-0865_ref_035","doi-asserted-by":"crossref","unstructured":"Adler, GK, Stowasser, M, Correa, RR, Khan, N, Kline, G, McGowan, MJ, et al.. Primary aldosteronism: an endocrine society clinical practice guideline. 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