Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Development and validation of a novel chemiluminescent immunoassay for diagnosing primary aldosteronism

Li Ge, Jian-Jun Ma¹, Meng-Ru Wu², Yun Jia¹, Ya-Li Xu³, Hong-Feng Xu¹

¹School of Traditional Chinese Medicine, Xinjiang Medical University; ²Departerment of Traditional Chinese Medicine, Xinjiang Occupational Disease Hospital, Xinjiang, Urumqi 830000; ³Department of Cardiovascular Endocrinology, Beitun Hospital, Tenth Division, Xinjiang Production and Construction Corps, Xinjiang, Beitun 836000, China.

For correspondence:- Hong-Feng Xu Email: xuhongfenghero@126.com Tel:+8615160986971

Accepted: 17 January 2021 Published: 28 February 2021

Citation: Ge L, Ma J, Wu M, Jia Y, Xu Y, Xu H. Development and validation of a novel chemiluminescent immunoassay for diagnosing primary aldosteronism. Trop J Pharm Res 2021; 20(2):369-375 doi: 10.4314/tjpr.v20i2.22

© 2021 The authors.
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Abstract

Purpose: To compare the diagnostic accuracy of plasma aldosterone concentration (PAC), plasma renin activity (PRA) and aldosterone-to-renin ratio (ARR) in primary aldosteronism (PA) using radioimmunoassay (RIA) and chemiluminescence immunoassay (CLIA) methods.

Methods: Both RIA and CLIA were used to analyze the PAC, PRA and ARR with subjects in standing or supine position, before and after a saline infusion test (SIT). The correlation between RIA and CLIA was measured by regression analysis. The receiver operating characteristic (ROC) curve was used to evaluate the diagnostic accuracy by RIA and CLIA.

Results: A positive correlation was found between PAC and PRA after SIT using RIA and CLIA (0.1745 and 0.3085, respectively). A positive correlation was found between the PAC and PRA in standing and supine position using RIA and CLIA (0.3979 vs 0.2399 and 0.1885 vs 0.4032, respectively). There was no obvious difference in AUCs of PAC, PRA, and ARR between RIA and CLIA (PAC: 0.91 vs. 0.89; PRA: 0.88 vs. 0.87; ARR: 0.93 vs. 0.92). In standing posture, the AUCs of PAC, PRA and ARR using RIA were 0.63, 0.72 and 0.78, respectively, and the results of CLIA were 0.65, 0.75 and 0.82, respectively. In supine posture, the AUC of PAC, PRA and ARR using RIA was 0.65, 0.68 and 0.71, respectively, and the results of CLIA were 0.68, 0.70 and 0.79, respectively.

Conclusion: Chemiluminescent assay is reliable for diagnosis of PA when compared with radioimmunoassay.

Keywords: Primary aldosteronism, Chemiluminescence immunoassay, Radioimmunoassay, Aldosterone Plasma renin activity, Aldosterone-to-renin ratio, Receiver operat