Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone
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Yicong Yin
Abstract
Background
This study aimed to quantify and compare serum aldosterone (sALD) levels through three different chemiluminescence immunoassays (CLIAs) and liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis.
Methods
Serum samples from 221 patients with suspected primary aldosteronism (PA) were retrospectively included in this study conducted at the Peking Union Medical College Hospital from June to August in 2017. sALD levels were determined using the LC-MS/MS method and three different CLIA systems, viz., DiaSorin® XL, iSYS and Auto Lumo A2000. Pooled fresh serum samples were used for recalibration. Passing-Bablok regression analysis, correlation matrix, and Bland-Altman plots were used to evaluate the concurrence among ALD levels determined using the three CLIAs.
Results
Within-laboratory precision of the four assays ranged from 2.1% to 9.4%, except the coefficient variation (CV) of one of the CLIAs, which exceeded 20.0% for samples with low sALD levels. sALD levels determined using LC-MS/MS were significantly lower than those determined using the other three CLIAs (p < 0.0001). Spearman’s correlation coefficient of the four assays ranged from 0.745 to 0.950 (p < 0.0001). The Bland-Altman plot showed that the average bias (%) for the three CLIAs and LC-MS/MS ranged from −69.3 to −49.2. After recalibration, this correlation did not improve among the assays. However, the bias and bias percentage at the medical decision level improved between LC-MS/MS and DiaSorin® XL/iSYS.
Conclusions
Significant inconsistencies between the results of CLIAs and LC-MS/MS indicate that different sALD measures cannot be used interchangeably.
Acknowledgments
The authors thank the participants, primary-care physicians and nurses participating in the survey.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This study was funded by the National Natural Science Foundation of China, Funder Id: http://dx.doi.org/10.13039/501100001809, (81702060) and by research grants from the China National Clinical Key Subject Program.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Loh KC, Koay ES, Khaw MC, Emmanuel SC, Young WF, Jr. Prevalence of primary aldosteronism among Asian hypertensive patients in Singapore. J Clin Endocrinol Metab 2000;85:2854–9.10.1210/jc.85.8.2854Suche in Google Scholar
2. Kline GA, Prebtani AP, Leung AA, Schiffrin EL. Primary aldosteronism: a common cause of resistant hypertension. Can Med Assoc J 2017;189:E773–8.10.1503/cmaj.161486Suche in Google Scholar PubMed PubMed Central
3. Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J, Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens 2003;17:349–52.10.1038/sj.jhh.1001554Suche in Google Scholar PubMed
4. Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension 2002;40:892–6.10.1161/01.HYP.0000040261.30455.B6Suche in Google Scholar
5. Milliez P, Girerd X, Plouin PF, Blacher J, Safar ME, Mourad JJ. Evidence for an increased rate of cardiovascular events in patients with primary aldosteronism. J Am Coll Cardiol 2005;45:1243–8.10.1016/j.jacc.2005.01.015Suche in Google Scholar PubMed
6. Stowasser M, Sharman J, Leano R, Gordon RD, Ward G, Cowley D, et al. Evidence for abnormal left ventricular structure and function in normotensive individuals with familial hyperaldosteronism type I. J Clin Endocrinol Metab 2005;90:5070–6.10.1210/jc.2005-0681Suche in Google Scholar PubMed
7. Catena C, Colussi G, Nadalini E, Chiuch A, Baroselli S, Lapenna R, et al. Cardiovascular outcomes in patients with primary aldosteronism after treatment. Arch Intern Med 2008;168:80–5.10.1001/archinternmed.2007.33Suche in Google Scholar PubMed
8. Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab 2008;19:88–90.10.1016/j.tem.2008.01.006Suche in Google Scholar PubMed
9. Catena C, Colussi G, Sechi LA. Mineralocorticoid receptor antagonists and renal involvement in primary aldosteronism: opening of a new era. Eur J Endocrinol 2013;168:C1–5.10.1530/EJE-12-0899Suche in Google Scholar PubMed
10. Sechi LA, Colussi G, Di Fabio A, Catena C. Cardiovascular and renal damage in primary aldosteronism: outcomes after treatment. Am J Hypertens 2010;23:1253–60.10.1038/ajh.2010.169Suche in Google Scholar PubMed
11. 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;101:1889–916.10.1210/jc.2015-4061Suche in Google Scholar PubMed
12. Stabler TV, Siegel AL. Chemiluminescence immunoassay of aldosterone in serum. Clin Chem 1991;37:1987–9.10.1093/clinchem/37.11.1987Suche in Google Scholar
13. Perschel FH, Schemer R, Seiler L, Reincke M, Deinum J, Maser-Gluth C, et al. Rapid screening test for primary hyperaldosteronism: ratio of plasma aldosterone to renin concentration determined by fully automated chemiluminescence immunoassays. Clin Chem 2004;50:1650–5.10.1373/clinchem.2004.033159Suche in Google Scholar PubMed
14. Schirpenbach C, Seiler L, Maser-Gluth C, Beuschlein F, Reincke M, Bidlingmaier M. Automated chemiluminescence-immunoassay for aldosterone during dynamic testing: comparison to radioimmunoassays with and without extraction steps. Clin Chem 2006;52:1749–55.10.1373/clinchem.2006.068502Suche in Google Scholar PubMed
15. Burrello J, Monticone S, Buffolo F, Lucchiari M, Tetti M, Rabbia F, et al. Diagnostic accuracy of aldosterone and renin measurement by chemiluminescent immunoassay and radioimmunoassay in primary aldosteronism. J Hypertens 2016;34:920–7.10.1097/HJH.0000000000000880Suche in Google Scholar PubMed
16. Van Der Gugten JG, Dubland J, Liu HF, Wang A, Joseph C, Holmes DT. 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 Clin Pathol 2012;65:457–62.10.1136/jclinpath-2011-200564Suche in Google Scholar PubMed
17. Turpeinen U, Hamalainen E, Stenman UH. Determination of aldosterone in serum by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2008;862:113–8.10.1016/j.jchromb.2007.11.005Suche in Google Scholar PubMed
18. Eisenhofer G, Dekkers T, Peitzsch M, Dietz AS, Bidlingmaier M, Treitl M, et al. Mass spectrometry-based adrenal and peripheral venous steroid profiling for subtyping primary aldosteronism. Clin Chem 2016;62:514–24.10.1373/clinchem.2015.251199Suche in Google Scholar PubMed
19. Hinchliffe E, Carter S, Owen LJ, Keevil BG. Quantitation of aldosterone in human plasma by ultra high performance liquid chromatography tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2013;913–914:19–23.10.1016/j.jchromb.2012.11.013Suche in Google Scholar PubMed
20. Yin Y, Yu S, Qiu L, Wang X, Wang D, Ma C, et al. Establishment of a rapid and simple liquid chromatography tandem mass spectrometry method for measuring aldosterone in urine. J Chromatogr B Analyt Technol Biomed Life Sci 2019;1113:84–90.10.1016/j.jchromb.2019.03.012Suche in Google Scholar PubMed
21. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59:491–500.10.1080/00365519950185229Suche in Google Scholar PubMed
22. Mayo Clinic Laboratories. Available at: https://www.mayocliniclabs.com.Suche in Google Scholar
23. Cheng X, Yu S, Jin C, Han S, Hu Y, Zhang K, et al. Comparison of three different assays for measuring thyroglobulin and thyroglobulin antibodies in patients with chronic lymphocytic thyroiditis. Clin Biochem 2017;50:1183–7.10.1016/j.clinbiochem.2017.08.004Suche in Google Scholar PubMed
24. Ray JA, Kushnir MM, Palmer J, Sadjadi S, Rockwood AL, Meikle AW. Enhancement of specificity of aldosterone measurement in human serum and plasma using 2D-LC-MS/MS and comparison with commercial immunoassays. J Chromatogr B Analyt Technol Biomed Life Sci 2014;970:102–7.10.1016/j.jchromb.2014.08.042Suche in Google Scholar PubMed
25. Lam L, Chiu WW, Davidson JS. Overestimation of aldosterone by immunoassay in renal impairment. Clin Chem 2016;62: 890–1.10.1373/clinchem.2016.255737Suche in Google Scholar PubMed
26. Blocki F, Zierold C, Olson G, Seeman J, Cummings S, Bonelli F. In defense of aldosterone measurement by immunoassay: a broader perspective. Clin Chem Lab Med 2017;55:e87–9.10.1515/cclm-2016-0707Suche in Google Scholar PubMed
27. Wu AH, French D. Implementation of liquid chromatography/mass spectrometry into the clinical laboratory. Clin Chim Acta 2013;420:4–10.10.1016/j.cca.2012.10.026Suche in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0706).
©2020 Walter de Gruyter GmbH, Berlin/Boston
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- Shortcomings in the evaluation of biomarkers in ovarian cancer: a systematic review
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- Clinical application of presepsin as diagnostic biomarker of infection: overview and updates
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- EFLM Paper
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