Abstract
Objectives
Aldosterone and renin determinations play an important role in the etiological diagnosis of secondary hypertension. The analytical performances of new aldosterone and renin immunoassays on the Lumipulse G600II® system (Fujierbio) were investigated and compared with those of the iSYS® system (IDS) on patients concerned by medical investigations in a context of suspected or proven Primary aldosteronism.
Methods
By using the Lumipulse® G Aldosterone and Renin assays we performed imprecision study, linearity and method comparison (n=107). Accuracy of this new renin assay was tested using the International Standard (WHO IS 68/356). We also assessed the equivalence of the different samples types (n=29).
Results
The imprecision evaluation showed all CVs <3% and <6% for Lumipulse® G Aldosterone and Renin assays respectively. The linearity was excellent over the clinical range and the comparison with the iSYS® assays (n=79) showed a strong correlation (R2=1) despite a slight tendency to underestimation (bias of −17.53 pg/mL or 48.56 pmol/L for aldosterone and −15.395 pg/mL for renin). Moreover, the contingency studies based on diagnostic criteria showed that Lumipulse® G results lead to the same clinical diagnosis that iSYS® results. A clear correlation was obtained between EDTA and heparin plasma as well as with the serum for all range of measures.
Conclusions
The Lumipulse® G Aldosterone and Renin assays present performances compatible with a routine use in medical laboratories. The precise quantification in the low range can be of interest in some clinical contexts especially standing/laying tests. However, the standardisation against the WHO International Standard Renin would be advisable.
Acknowledgments
Reagents, calibrators, quality controls for Lumipulse® G assays used in this study were kindly provided by Fujirebio. The authors thank Leo Brochon and Florina Toma (residents) for their contribution to the project.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The protocol was performed according to the principles of the Declaration of Helsinki, approved by the Ethic Committee of Montpellier.
References
1. Käyser, 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 Clin Endocrinol Metab 2016;101:2826–35. https://doi.org/10.1210/jc.2016-1472.Search in Google Scholar PubMed
2. Rossi, GP, Bernini, G, Caliumi, C, Desideri, G, Fabris, B, Ferri, C, et al.. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol 2006;48:2293–300. https://doi.org/10.1016/j.jacc.2006.07.059.Search in Google Scholar PubMed
3. 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
4. Tanabe, A, Naruse, M, Takagi, S, Tsuchiya, K, Imaki, T, Takano, K. Variability in the renin/aldosterone profile under random and standardized sampling conditions in primary aldosteronism. J Clin Endocrinol Metab 2003;88:2489–94. https://doi.org/10.1210/jc.2002-021476.Search in Google Scholar PubMed
5. Yozamp, N, Hundemer, GL, Moussa, M, Underhill, J, Fudim, T, Sacks, B, et al.. Intraindividual variability of aldosterone concentrations in primary aldosteronism: implications for case detection. Hypertension 2021;77:891–9. https://doi.org/10.1161/hypertensionaha.120.16429.Search in Google Scholar PubMed PubMed Central
6. EP15-A3-User verification of precision and estimation of bias. Wayne (PA): Clinical and Laboratory Standards Institute; 2014, vol. 34:1–81 pp. Available from: https://clsi.org/media/1431/ep15a3_sample.pdf.Search in Google Scholar
7. EP17A2E - Evaluation of detection capability for clinical laboratory measurement procedures. Wayne (PA): Clinical and Laboratory Standards Institute; 2012:1–80 pp.Search in Google Scholar
8. Putheti, R, Okigbo, R, Patil, S, Advanapu, M, Leburu, R. Method development and validations: characterization of critical elements in the development of pharmaceuticals. Int J Heal Res 2008;1:3–14. https://doi.org/10.4314/ijhr.v1i1.55342.Search in Google Scholar
9. Amar, L, Baguet, JP, Bardet, S, Chaffanjon, P, Chamontin, B, Douillard, C, et al.. Consensus sur l’hyperaldostéronisme primaire de la SFE/SFHTA/AFCE: introduction et guide. Ann Endocrinol 2016;77:179–86. https://doi.org/10.1016/j.ando.2016.05.001.Search in Google Scholar PubMed
10. Manolopoulou, J, Fischer, E, Dietz, A, Diederich, S, Holmes, D, Junnila, R, et al.. Clinical validation for the aldosterone-to-renin ratio and aldosterone suppression testing using simultaneous fully automated chemiluminescence immunoassays. J Hypertens 2015;33:2500–11. https://doi.org/10.1097/hjh.0000000000000727.Search in Google Scholar PubMed
11. 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 Hum Hypertens [Internet] 2022;36:77–85. https://doi.org/10.1038/s41371-020-00465-5.Search in Google Scholar PubMed PubMed Central
12. Dick, SM, Queiroz, M, Bernardi, BL, Dall’Agnol, A, Brondani, LA, Silveiro, SP. Update in diagnosis and management of primary aldosteronism. Clin Chem Lab Med 2018;56:360–72. https://doi.org/10.1515/cclm-2017-0217.Search in Google Scholar PubMed
13. Guggenmoos-Holzmann, I. The meaning of kappa: probabilistic concepts of reliability and validity revisited. J Clin Epidemiol 1996;49:775–82.10.1016/0895-4356(96)00011-XSearch in Google Scholar
14. Oddoze, C, Lombard, E, Portugal, H. Stability study of 81 analytes in human whole blood, in serum and in plasma. Clin Biochem [Internet] 2012;45:464–9. https://doi.org/10.1016/j.clinbiochem.2012.01.012.Search in Google Scholar PubMed
15. Aarsand, AK, Fernandez-Calle, P, Webster, C, Coskun, A, Gonzales-Lao, E, Diaz-Garzon, J, et al.. The EFLM biological variation database; 2021. Available from: https://biologicalvariation.eu/.Search in Google Scholar
16. Booth, BP, Simon, WC. Validation of analytical methods. In: New drug development: regulatory paradigms for clinical pharmacology and biopharmaceutics. Boca Raton: CRC Press; 2016:138–59 pp. https://doi.org/10.1201/9780203026427-15.Search in Google Scholar
17. Williams, TA, Reincke, M. Diagnosis and management of primary aldosteronism: the endocrine society guideline 2016 revisited. Eur J Endocrinol 2018;179:R19–29. https://doi.org/10.1530/eje-17-0990.Search in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0576).
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