The Saline Infusion Test for Primary Aldosteronism: Implications of Immunoassay Inaccuracy.

Bibliographic Details
Title: The Saline Infusion Test for Primary Aldosteronism: Implications of Immunoassay Inaccuracy.
Authors: Eisenhofer, Graeme, Kurlbaum, Max, Peitzsch, Mirko, Constantinescu, Georgiana, Remde, Hanna, Schulze, Manuel, Kaden, Denise, Müller, Lisa Marie, Fuss, Carmina T., Kunz, Sonja, Kołodziejczyk-Kruk, Sylwia, Gruber, Sven, Prejbisz, Aleksander, Beuschlein, Felix, Williams, Tracy Ann, Reincke, Martin, Lenders, Jacques W. M., Bidlingmaier, Martin
Source: Journal of Clinical Endocrinology & Metabolism; May2022, Vol. 107 Issue 5, pe2027-e2036, 10p
Subject Terms: HYPERALDOSTERONISM, ALDOSTERONE, IMMUNOASSAY
Abstract: Context: Diagnosis of primary aldosteronism (PA) for many patients depends on positive results for the saline infusion test (SIT). Plasma aldosterone is often measured by immunoassays, which can return inaccurate results. Objective: This study aimed to establish whether differences in aldosterone measurements by immunoassay versus mass spectrometry (MS) might impact confirmatory testing for PA. Methods: This study, involving 240 patients tested using the SIT at 5 tertiary care centers, assessed discordance between immunoassay and MS-based measurements of plasma aldosterone. Results: Plasma aldosterone measured by Liaison and iSYS immunoassays were respectively 86% and 58% higher than determined by MS. With an immunoassay-based SIT cutoff for aldosterone of 170 pmol/L, 78 and 162 patients had, respectivel, negative and positive results. All former patients had MS-based measurements of aldosterone < 117 pmol/L, below MS-based cutoffs of 162 pmol/L. Among the 162 patients with pathogenic SIT results, MS returned nonpathologic results in 62, including 32 under 117 pmol/L. Repeat measurements by an independent MS method confirmed nonpathogenic results in 53 patients with discordant results. Patients with discordant results showed a higher (P < 0.0001) prevalence of nonlateralized than lateralized adrenal aldosterone production than patients with concordant results (83% vs 28%). Among patients with nonlateralized aldosterone production, 66% had discordant results. Discordance was more prevalent for the Liaison than iSYS immunoassay (32% vs 16%; P = 0.0065) and was eliminated by plasma purification to remove interferents. Conclusion: These findings raise concerns about the validity of immunoassay-based diagnosis of PA in over 60% of patients with presumed bilateral disease. We provide a simple solution to minimize immunoassay inaccuracy-associated misdiagnosis of PA. [ABSTRACT FROM AUTHOR]
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  Data: The Saline Infusion Test for Primary Aldosteronism: Implications of Immunoassay Inaccuracy.
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  Group: Src
  Data: Journal of Clinical Endocrinology &amp; Metabolism; May2022, Vol. 107 Issue 5, pe2027-e2036, 10p
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  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22HYPERALDOSTERONISM%22&quot;&gt;HYPERALDOSTERONISM&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22ALDOSTERONE%22&quot;&gt;ALDOSTERONE&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22IMMUNOASSAY%22&quot;&gt;IMMUNOASSAY&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Context: Diagnosis of primary aldosteronism (PA) for many patients depends on positive results for the saline infusion test (SIT). Plasma aldosterone is often measured by immunoassays, which can return inaccurate results. Objective: This study aimed to establish whether differences in aldosterone measurements by immunoassay versus mass spectrometry (MS) might impact confirmatory testing for PA. Methods: This study, involving 240 patients tested using the SIT at 5 tertiary care centers, assessed discordance between immunoassay and MS-based measurements of plasma aldosterone. Results: Plasma aldosterone measured by Liaison and iSYS immunoassays were respectively 86% and 58% higher than determined by MS. With an immunoassay-based SIT cutoff for aldosterone of 170 pmol/L, 78 and 162 patients had, respectivel, negative and positive results. All former patients had MS-based measurements of aldosterone &lt; 117 pmol/L, below MS-based cutoffs of 162 pmol/L. Among the 162 patients with pathogenic SIT results, MS returned nonpathologic results in 62, including 32 under 117 pmol/L. Repeat measurements by an independent MS method confirmed nonpathogenic results in 53 patients with discordant results. Patients with discordant results showed a higher (P &lt; 0.0001) prevalence of nonlateralized than lateralized adrenal aldosterone production than patients with concordant results (83% vs 28%). Among patients with nonlateralized aldosterone production, 66% had discordant results. Discordance was more prevalent for the Liaison than iSYS immunoassay (32% vs 16%; P = 0.0065) and was eliminated by plasma purification to remove interferents. Conclusion: These findings raise concerns about the validity of immunoassay-based diagnosis of PA in over 60% of patients with presumed bilateral disease. We provide a simple solution to minimize immunoassay inaccuracy-associated misdiagnosis of PA. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: &lt;i&gt;Copyright of Journal of Clinical Endocrinology &amp; Metabolism is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder&#39;s express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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        Value: 10.1210/clinem/dgab924
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      – Code: eng
        Text: English
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      Pagination:
        PageCount: 10
        StartPage: e2027
    Subjects:
      – SubjectFull: HYPERALDOSTERONISM
        Type: general
      – SubjectFull: ALDOSTERONE
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      – SubjectFull: IMMUNOASSAY
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