American Journal of Clinical and Experimental Medicine

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Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility

Received: Oct. 29, 2019    Accepted: Nov. 20, 2019    Published: Dec. 06, 2019
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Abstract

The diagnostic procedure for the evaluation of Cushing’s syndrome is performed by any of the following biochemical tests: urine free cortisol, salivary cortisol at 11 pm and serum cortisol post 1 mg of dexamethasone. Collection of saliva samples is simple and noninvasive, thus being a method of choice for the evaluation of risk populations. The aim of this work is to analyze the performance of an automated chemiluminescent method for measurement of salivary cortisol at 11 pm according to the new quality guidelines and assess its clinical utility. Cortisol levels were measured in samples obtained by passive drooling from 32 healthy subjects and 9 patients with Cushing’s syndrome. Matrix effect, linearity, limit of blank, limit of quantitation, recovery and diagnostic performance were assessed. The Unicel 600 DXI Access Beckman Coulter chemiluminescent automated analyzer was used. The standard curve provided by the manufacturer was adapted to measure cortisol concentrations in saliva. Matrix effect: equation of the curve using salivary matrix: y=-1.824x+3.491 (95% CI=-2.068 to -1.582) vs. Equation of the curve using diluent matrix: y=-1.833x+3.394 (95% CI=-1.961 to -1.704). There is overlapping of both curves. Linearity: linear assay between 1.8 nmol/L and 108.0 nmol/L. Limit of blank: 0.1 nmol/L. Limit of quantitation: 1.8 nmol/L (TAE of 25%). Recovery: standard cortisol solution concentration 5 nmol/L: 102%; 10 nmol/L: 107%; 40nmol/L: 115%. Diagnostic performance: median and ranges in healthy subjects: 2.0 nmol/L (<2.0-9.0 nmol/L); Cushing’s syndrome: 30.3 nmol/L (15.4-61.0 nmol/L). ROC curve cutoff value: 9.0 nmol/L (100% Specificity; 100% Sensitivity; AUC=1.00). The method used provides excellent analytical performance for cortisol measurement in saliva at 11 pm, which makes it a valuable biochemical tool both for screening populations at risk for Cushing’s syndrome and for the follow-up and diagnosis of this condition.

DOI 10.11648/j.ajcem.20190706.12
Published in American Journal of Clinical and Experimental Medicine ( Volume 7, Issue 6, November 2019 )
Page(s) 130-134
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Salivary Cortisol, Cushing´s Syndrome, Analytical Performance

References
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[2] Yaneva, M; Mosnier-Pudar, H; Dugué, M; Grabar, S; Fulla, I; Bertanga, X. Midnigthsalivary cortisol for the initial diagnosis of Cushing´s Syndrome of various causes. J ClinEndocrinolMetabol.2004; 89 (7): (3346-3351).
[3] Lopez Mondéjar, P;Fuentes, M; Mauri, M; Mora, A; Pérez Soto, M; Vargas, F; Hidalgo, A.Determinación de cortisol salival en el diagnóstico de Cushing pediátrico. An. Pediatr. Barcelona. 2006; 64 (3): (270-272).
[4] Kaufman E; Lamster B. The diagnostic applications of saliva. Crit. Rev. Oral Biol. Med.; 2002; 13 (2): 197-212.
[5] Gröschl, M. Current status of salivary hormone analysis. Clinical Chemistry. 2008; 54:11 (1759-1769).
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[10] Fabre B.; MeschV; Oneto A; Macalini G; Grosman H; Aranda C; BergG.La saliva y su utilidad en la evaluación de la función endocrinológica. Revista SAEGRE,2009;vol XVI; nº3: (26-43).
[11] Lepez M; Caamaño E; Romero C; Fiedler Y; Araya V. Determinación de los niveles de cortisol salival en una muestra de sujetos de Santiago de Chile. Rev. Med. Chile; 2010; vol 138;nº2:(168-174).
[12] Raff, H. Utility of salivary cortisol measurements in Cushing´s Syndrome and adrenal insufficiency. Clin Endocrinol Metab. 2009; 94(10): (3647-3655).
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[14] Walker, R.; Riad-Fahmy, D.; Read, G. Adrenal status assessed by directradioimmunoassay of cortisol in whole saliva orparotid saliva. Clin Chem. 1978; 24: (1460-1463).
[15] Beckman Coulter. Acess Immunoassay Systems. Access Cortisol. 2015.
[16] Fabre, B; Oneto, A; Schonfeld, C; Belli, S; Aranda, C. Evaluación del comportamiento de tres inmunoensayos (IE) en la medición de cortisol en saliva en una población normal. Revista Argentina de Endocrinología RAEM 2005; vol 42, nº suplementario, (p. 133).
[17] CLSI. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, 1st Edition. CLSI document EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2003.
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    Maria Alejandra Kloberdanz, Lucia Fernandez, Agustina Peverini, Fernando Smithuis, Adrian Aymard, et al. (2019). Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility. American Journal of Clinical and Experimental Medicine, 7(6), 130-134. https://doi.org/10.11648/j.ajcem.20190706.12

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    Maria Alejandra Kloberdanz; Lucia Fernandez; Agustina Peverini; Fernando Smithuis; Adrian Aymard, et al. Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility. Am. J. Clin. Exp. Med. 2019, 7(6), 130-134. doi: 10.11648/j.ajcem.20190706.12

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    AMA Style

    Maria Alejandra Kloberdanz, Lucia Fernandez, Agustina Peverini, Fernando Smithuis, Adrian Aymard, et al. Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility. Am J Clin Exp Med. 2019;7(6):130-134. doi: 10.11648/j.ajcem.20190706.12

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  • @article{10.11648/j.ajcem.20190706.12,
      author = {Maria Alejandra Kloberdanz and Lucia Fernandez and Agustina Peverini and Fernando Smithuis and Adrian Aymard and Claudio Aranda and Bibiana Fabre and Martin Repetto and Adriana Oneto},
      title = {Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility},
      journal = {American Journal of Clinical and Experimental Medicine},
      volume = {7},
      number = {6},
      pages = {130-134},
      doi = {10.11648/j.ajcem.20190706.12},
      url = {https://doi.org/10.11648/j.ajcem.20190706.12},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.ajcem.20190706.12},
      abstract = {The diagnostic procedure for the evaluation of Cushing’s syndrome is performed by any of the following biochemical tests: urine free cortisol, salivary cortisol at 11 pm and serum cortisol post 1 mg of dexamethasone. Collection of saliva samples is simple and noninvasive, thus being a method of choice for the evaluation of risk populations. The aim of this work is to analyze the performance of an automated chemiluminescent method for measurement of salivary cortisol at 11 pm according to the new quality guidelines and assess its clinical utility. Cortisol levels were measured in samples obtained by passive drooling from 32 healthy subjects and 9 patients with Cushing’s syndrome. Matrix effect, linearity, limit of blank, limit of quantitation, recovery and diagnostic performance were assessed. The Unicel 600 DXI Access Beckman Coulter chemiluminescent automated analyzer was used. The standard curve provided by the manufacturer was adapted to measure cortisol concentrations in saliva. Matrix effect: equation of the curve using salivary matrix: y=-1.824x+3.491 (95% CI=-2.068 to -1.582) vs. Equation of the curve using diluent matrix: y=-1.833x+3.394 (95% CI=-1.961 to -1.704). There is overlapping of both curves. Linearity: linear assay between 1.8 nmol/L and 108.0 nmol/L. Limit of blank: 0.1 nmol/L. Limit of quantitation: 1.8 nmol/L (TAE of 25%). Recovery: standard cortisol solution concentration 5 nmol/L: 102%; 10 nmol/L: 107%; 40nmol/L: 115%. Diagnostic performance: median and ranges in healthy subjects: 2.0 nmol/L (<2.0-9.0 nmol/L); Cushing’s syndrome: 30.3 nmol/L (15.4-61.0 nmol/L). ROC curve cutoff value: 9.0 nmol/L (100% Specificity; 100% Sensitivity; AUC=1.00). The method used provides excellent analytical performance for cortisol measurement in saliva at 11 pm, which makes it a valuable biochemical tool both for screening populations at risk for Cushing’s syndrome and for the follow-up and diagnosis of this condition.},
     year = {2019}
    }
    

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    T1  - Evaluation of the Performance of an Automated Chemiluminescent Method (Access Beckman Coulter) for Determination of Salivary Cortisol and Clinical Utility
    AU  - Maria Alejandra Kloberdanz
    AU  - Lucia Fernandez
    AU  - Agustina Peverini
    AU  - Fernando Smithuis
    AU  - Adrian Aymard
    AU  - Claudio Aranda
    AU  - Bibiana Fabre
    AU  - Martin Repetto
    AU  - Adriana Oneto
    Y1  - 2019/12/06
    PY  - 2019
    N1  - https://doi.org/10.11648/j.ajcem.20190706.12
    DO  - 10.11648/j.ajcem.20190706.12
    T2  - American Journal of Clinical and Experimental Medicine
    JF  - American Journal of Clinical and Experimental Medicine
    JO  - American Journal of Clinical and Experimental Medicine
    SP  - 130
    EP  - 134
    PB  - Science Publishing Group
    SN  - 2330-8133
    UR  - https://doi.org/10.11648/j.ajcem.20190706.12
    AB  - The diagnostic procedure for the evaluation of Cushing’s syndrome is performed by any of the following biochemical tests: urine free cortisol, salivary cortisol at 11 pm and serum cortisol post 1 mg of dexamethasone. Collection of saliva samples is simple and noninvasive, thus being a method of choice for the evaluation of risk populations. The aim of this work is to analyze the performance of an automated chemiluminescent method for measurement of salivary cortisol at 11 pm according to the new quality guidelines and assess its clinical utility. Cortisol levels were measured in samples obtained by passive drooling from 32 healthy subjects and 9 patients with Cushing’s syndrome. Matrix effect, linearity, limit of blank, limit of quantitation, recovery and diagnostic performance were assessed. The Unicel 600 DXI Access Beckman Coulter chemiluminescent automated analyzer was used. The standard curve provided by the manufacturer was adapted to measure cortisol concentrations in saliva. Matrix effect: equation of the curve using salivary matrix: y=-1.824x+3.491 (95% CI=-2.068 to -1.582) vs. Equation of the curve using diluent matrix: y=-1.833x+3.394 (95% CI=-1.961 to -1.704). There is overlapping of both curves. Linearity: linear assay between 1.8 nmol/L and 108.0 nmol/L. Limit of blank: 0.1 nmol/L. Limit of quantitation: 1.8 nmol/L (TAE of 25%). Recovery: standard cortisol solution concentration 5 nmol/L: 102%; 10 nmol/L: 107%; 40nmol/L: 115%. Diagnostic performance: median and ranges in healthy subjects: 2.0 nmol/L (<2.0-9.0 nmol/L); Cushing’s syndrome: 30.3 nmol/L (15.4-61.0 nmol/L). ROC curve cutoff value: 9.0 nmol/L (100% Specificity; 100% Sensitivity; AUC=1.00). The method used provides excellent analytical performance for cortisol measurement in saliva at 11 pm, which makes it a valuable biochemical tool both for screening populations at risk for Cushing’s syndrome and for the follow-up and diagnosis of this condition.
    VL  - 7
    IS  - 6
    ER  - 

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Author Information
  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina

  • Clinical Biochemistry Department, Faculty of Pharmacy and Biochemistry, INFIBIOC, University of Buenos Aires, Buenos Aires, CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina; Clinical Biochemistry Department, Faculty of Pharmacy and Biochemistry, INFIBIOC, University of Buenos Aires, Buenos Aires, CABA, Argentina

  • Laboratory of Clinical Analysis of Buenos Aires (TCba-LACba), CABA, Argentina; Clinical Biochemistry Department, Faculty of Pharmacy and Biochemistry, INFIBIOC, University of Buenos Aires, Buenos Aires, CABA, Argentina

  • Section