Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone

Yicong Yin 1 , Chaochao Ma 1 , Songlin Yu 1 , Wenjing Liu 2 , Danchen Wang 1 , Tingting You 1 , Qian Cheng 1  and Ling Qiu 1
  • 1 Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • 2 Waters Corporation Shanghai Science and Technology Co. Ltd., Beijing, P.R. China
Yicong Yin
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Chaochao Ma
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Songlin Yu
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Wenjing Liu, Danchen Wang
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Tingting You
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Qian Cheng
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Search for other articles:
  • degruyter.comGoogle Scholar
and Ling Qiu
  • Corresponding author
  • Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, P.R. China
  • Email
  • Search for other articles:
  • degruyter.comGoogle Scholar

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.

    • Supplementary Material
  • 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.

    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 12.

    Stabler TV, Siegel AL. Chemiluminescence immunoassay of aldosterone in serum. Clin Chem 1991;37:1987–9.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 22.

    Mayo Clinic Laboratories. Available at: https://www.mayocliniclabs.com.

  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • Crossref
    • PubMed
    • Export Citation
  • 25.

    Lam L, Chiu WW, Davidson JS. Overestimation of aldosterone by immunoassay in renal impairment. Clin Chem 2016;62: 890–1.

    • Crossref
    • PubMed
    • Export Citation
  • 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.

    • PubMed
    • Export Citation
  • 27.

    Wu AH, French D. Implementation of liquid chromatography/mass spectrometry into the clinical laboratory. Clin Chim Acta 2013;420:4–10.

    • Crossref
    • PubMed
    • Export Citation
Purchase article
Get instant unlimited access to the article.
$42.00
Log in
Already have access? Please log in.


or
Log in with your institution

Journal + Issues

Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.

Search