Abstract
Objectives
Accurate measurements of renin and aldosterone levels play an important role in primary aldosteronism screening, which is of great importance in the management and categorization of hypertension. The objective of this study is to investigate the current status of plasma renin and aldosterone measurements in China, which is achieved by analyzing the results of 526 clinical laboratories nationwide for three pooled fresh plasma samples derived from more than 2,000 patients.
Methods
Renin and aldosterone in three pooled plasma samples were measured four times in 526 laboratories employing various measurement systems. The inter- and intra-laboratory %CV were calculated and compared. To determine the source of the substantial inter-laboratory %CV, laboratories were categorized according to the measurement systems they are using, and both the inter- and intra-measurement-system %CV were calculated and compared.
Results
Regarding renin, the majority of laboratories use four primary commercial immunoassays. However, for aldosterone, in addition to commercial immunoassays, laboratory-developed liquid chromatography-tandem mass spectrometry (LC-MS) methods are also used by laboratories. The median values of intra-laboratory %CVs, intra-measurement-system %CVs, inter-laboratory %CVs, and inter-measurement systems %CVs varied between 1.6 and 2.6 %, 4.6 and 14.9 %, 8.3 and 25.7 %, and 10.0 and 34.4 % for renin, respectively. For aldosterone, these values ranged from 1.4 to 2.2 %, 2.5–14.7 %, 9.9–31.0 %, and 10.0–35.5 %, respectively.
Conclusions
The precision within laboratories and measurement systems for plasma renin and aldosterone measurements is satisfactory. However, the comparability between laboratories using different measurement systems remains lacking, indicating the long way to achieve standardization and harmonization for these two analytes.
-
Research ethics: This study has been got the permission from the Ethics Committee of Beijing Hospital, with exemption for obtaining informed consent (approval No. 2021BJYYEC-234-02).
-
Informed consent: Not applicable.
-
Author contributions: Weiyan Zhou did the experiments, provided the idea, edited and reviewed the manuscript. Yuhang Deng analyzed the data and wrote this manuscript, Wenjun Ma, Qian Zhang, Kaijun Wang, Wei Gan, Haijian Zhao help collect the plasma samples, wenxiang Chen, Jun Cai and Chuanbao Zhang provided the idea of this study. The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: The authors state no conflict of interest.
-
Research funding: This study is supported by the Capital’s Funds for Health Improvement and Research (2024-2-4059), National High Level Hospital Clinical Research Funding (BJ-2023-094).
-
Data availability: Not applicable.
References
1. Yin, R, Yin, L, Li, L, Silva-Nash, J, Tan, J, Pan, Z, et al.. Hypertension in China: burdens, guidelines and policy responses: a state-of-the-art review. J Hum Hypertens 2022;36:126–34. https://doi.org/10.1038/s41371-021-00570-z.Search in Google Scholar PubMed PubMed Central
2. Funder, JW, Carey, RM, Mantero, F, Murad, MH, Reincke, M, Shibata, H, et al.. The management of primary aldosteronism: case detection, diagnosis, and treatment: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2016;101:1889–916. https://doi.org/10.1210/jc.2015-4061.Search in Google Scholar PubMed
3. 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 Am Coll Cardiol 2017;69:1811–20. https://doi.org/10.1016/j.jacc.2017.01.052.Search in Google Scholar PubMed
4. Funder, JW. Primary aldosteronism: present and future. Vitam Horm 2019;109:285–302. https://doi.org/10.1016/bs.vh.2018.10.006.Search in Google Scholar PubMed
5. Monticone, S, D’Ascenzo, F, Moretti, C, Williams, TA, Veglio, F, Gaita, F, et al.. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol 2018;6:41–50. https://doi.org/10.1016/s2213-8587(17)30319-4.Search in Google Scholar
6. Hundemer, GL, Curhan, GC, Yozamp, N, Wang, M, Vaidya, A. Cardiometabolic outcomes and mortality in medically treated primary aldosteronism: a retrospective cohort study. Lancet Diabetes Endocrinol 2018;6:51–9. https://doi.org/10.1016/s2213-8587(17)30367-4.Search in Google Scholar PubMed PubMed Central
7. Murata, M, Kitamura, T, Tamada, D, Mukai, K, Kurebayashi, S, Yamamoto, T, et al.. Plasma aldosterone level within the normal range is less associated with cardiovascular and cerebrovascular risk in primary aldosteronism. J Hypertens 2017;35:1079–85. https://doi.org/10.1097/hjh.0000000000001251.Search in Google Scholar
8. Young, WJ. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med 2019;285:126–48. https://doi.org/10.1111/joim.12831.Search in Google Scholar PubMed
9. Martin, RS, Hayslett, JP. Role of aldosterone in the mechanism of renal potassium adaptation. Pflugers Arch 1986;407:76–81. https://doi.org/10.1007/bf00580724.Search in Google Scholar PubMed
10. Vetter, H, Vetter, W. Regulation of aldosterone secretion in primary aldosteronism. Horm Metab Res 1975;7:418–24. https://doi.org/10.1055/s-0028-1093697.Search in Google Scholar PubMed
11. Giacchetti, G, Opocher, G, Sarzani, R, Rappelli, A, Mantero, F. Angiotensin II and the adrenal. Clin Exp Pharmacol Physiol 1996;23:S119–24. https://doi.org/10.1111/j.1440-1681.1996.tb03072.x.Search in Google Scholar PubMed
12. Gordon, RD. Primary aldosteronism. J Endocrinol Invest 1995;18:495–511. https://doi.org/10.1007/bf03349761.Search in Google Scholar
13. Turcu, AF, Yang, J, Vaidya, A. Primary aldosteronism – a multidimensional syndrome. Nat Rev Endocrinol 2022;18:665–82. https://doi.org/10.1038/s41574-022-00730-2.Search in Google Scholar PubMed
14. Reincke, M, Bancos, I, Mulatero, P, Scholl, UI, Stowasser, M, Williams, TA. Diagnosis and treatment of primary aldosteronism. Lancet Diabetes Endocrinol 2021;9:876–92. https://doi.org/10.1016/s2213-8587(21)00210-2.Search in Google Scholar PubMed
15. Coulon, C, Lotierzo, M, Fesler, P, Roubille, C, Badiou, S, Dupuy, AM, et al.. Analytical evaluation and bioclinical validation of new aldosterone and renin immunoassays. Clin Chem Lab Med 2022;60:1763–71. https://doi.org/10.1515/cclm-2022-0576.Search in Google Scholar PubMed
16. Giangrande, C, Vaneeckhoutte, H, Boeuf, A, Lalere, B, Hirtz, C, Lehmann, S, et al.. Development of a candidate reference measurement procedure by ID-LC-MS/MS for total tau protein measurement in cerebrospinal fluid (CSF). Clin Chem Lab Med 2023;61:1235–44. https://doi.org/10.1515/cclm-2022-1250.Search in Google Scholar PubMed
17. Taibon, J, Santner, T, Singh, N, Ibrahim, SC, Babitzki, G, Köppl, D, et al.. An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of aldosterone in human serum and plasma. Clin Chem Lab Med 2023;61:1902–16. https://doi.org/10.1515/cclm-2022-0996.Search in Google Scholar PubMed
18. Stöckl, D, Reinauer, H, Thienpont, LM, De Leenheer, AP. Determination of aldosterone in human serum by isotope dilution gas chromatography/mass spectrometry using a new heptafluorobutyryl derivative. Biol Mass Spectrom 1991;20:657–64. https://doi.org/10.1002/bms.1200201102.Search in Google Scholar PubMed
19. Juutilainen, A, Savolainen, K, Romppanen, J, Turpeinen, U, Hämäläinen, E, Kemppainen, J, et al.. Combination of LC-MS/MS aldosterone and automated direct renin in screening for primary aldosteronism. Clin Chim Acta 2014;433:209–15. https://doi.org/10.1016/j.cca.2014.03.015.Search in Google Scholar PubMed
20. Deng, Y, Zhang, C, Wang, J, Zeng, J, Zhang, J, Zhang, T, et al.. An accurate isotope dilution liquid chromatography-tandem mass spectrometry method for serum C-peptide and its use in harmonization in China. Ann Lab Med 2023;43:345–54. https://doi.org/10.3343/alm.2023.43.4.345.Search in Google Scholar PubMed PubMed Central
21. Little, RR, Wielgosz, RI, Josephs, R, Kinumi, T, Takatsu, A, Li, H, et al.. Implementing a reference measurement system for C-peptide: successes and lessons learned. Clin Chem 2017;63:1447–56. https://doi.org/10.1373/clinchem.2016.269274.Search in Google Scholar PubMed PubMed Central
© 2024 Walter de Gruyter GmbH, Berlin/Boston
