Analytical evaluation and bioclinical validation of new aldosterone and renin immunoassays
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Caroline Coulon
,
Manuela Lotierzo
,
Pierre Fesler
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.
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0576).
© 2022 Walter de Gruyter GmbH, Berlin/Boston
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