The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men

Outi Itkonen; Niels Jonker; Aasne K Aarsand; Sverre Sandberg; Jorge Diaz-Garzon; Pilar Fernandez-Calle; Abdurrahman Coskun; William A. Bartlett; Massimo Locatelli; Anna Carobene

doi:10.1016/j.cca.2024.117806

The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men

Outi Itkonen (Lead / Corresponding author), Niels Jonker, Aasne K Aarsand, Sverre Sandberg, Jorge Diaz-Garzon, Pilar Fernandez-Calle, Abdurrahman Coskun, William A. Bartlett, Massimo Locatelli, Anna Carobene

Biomedical Engineering

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Abstract

BACKGROUND: Knowledge of biological variation (BV) of hormones is essential for interpretation of laboratory tests and for diagnostics of endocrinological and reproductive diseases. There is a lack of robust BV data for many hormones in men.

METHODS: We used serum samples collected weekly over 10 weeks from the European Biological Variation Study (EuBIVAS) to determine BV of testosterone, follicle-stimulating hormone (FSH), prolactin, luteinizing hormone (LH) and dehydroepiandrosterone sulfate (DHEA-S) in 38 men. We derived within-subject (CVI) and between-subject (CVG) BV estimates by CV-ANOVA after trend, outlier, and homogeneity analysis and calculated reference change values, index of individuality (II), and analytical performance specifications.

RESULTS: The CVI estimates were 10 % for testosterone, 8 % for FSH, 13 % for prolactin, 22 % for LH, and 9 % for DHEA-S, respectively. The IIs ranged between 0.14 for FSH to 0.66 for LH, indicating high individuality.

CONCLUSIONS: In this study, we have used samples from the highly powered EuBIVAS study to derive BV estimates for testosterone, FSH, prolactin, LH and DHEA-S in men. Our data confirm previously published BV estimates of testosterone, FSH and LH. For prolactin and DHEA-S BV data for men are reported for the first time.

Original language	English
Article number	117806
Number of pages	7
Journal	Clinica Chimica Acta
Volume	555
Early online date	9 Feb 2024
DOIs	https://doi.org/10.1016/j.cca.2024.117806
Publication status	Published - 1 Mar 2024

Keywords

Biological variation
Clinical interpretation
EuBIVAS
Hormones
Laboratory medicine
Reference change value

ASJC Scopus subject areas

Biochemistry, medical
Biochemistry
Clinical Biochemistry

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Itkonen, O., Jonker, N., Aarsand, A. K., Sandberg, S., Diaz-Garzon, J., Fernandez-Calle, P., Coskun, A., Bartlett, W. A., Locatelli, M., & Carobene, A. (2024). The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men. Clinica Chimica Acta, 555, Article 117806. https://doi.org/10.1016/j.cca.2024.117806

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title = "The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men",

abstract = "BACKGROUND: Knowledge of biological variation (BV) of hormones is essential for interpretation of laboratory tests and for diagnostics of endocrinological and reproductive diseases. There is a lack of robust BV data for many hormones in men.METHODS: We used serum samples collected weekly over 10 weeks from the European Biological Variation Study (EuBIVAS) to determine BV of testosterone, follicle-stimulating hormone (FSH), prolactin, luteinizing hormone (LH) and dehydroepiandrosterone sulfate (DHEA-S) in 38 men. We derived within-subject (CVI) and between-subject (CVG) BV estimates by CV-ANOVA after trend, outlier, and homogeneity analysis and calculated reference change values, index of individuality (II), and analytical performance specifications.RESULTS: The CVI estimates were 10 % for testosterone, 8 % for FSH, 13 % for prolactin, 22 % for LH, and 9 % for DHEA-S, respectively. The IIs ranged between 0.14 for FSH to 0.66 for LH, indicating high individuality.CONCLUSIONS: In this study, we have used samples from the highly powered EuBIVAS study to derive BV estimates for testosterone, FSH, prolactin, LH and DHEA-S in men. Our data confirm previously published BV estimates of testosterone, FSH and LH. For prolactin and DHEA-S BV data for men are reported for the first time.",

keywords = "Biological variation, Clinical interpretation, EuBIVAS, Hormones, Laboratory medicine, Reference change value",

author = "Outi Itkonen and Niels Jonker and Aarsand, {Aasne K} and Sverre Sandberg and Jorge Diaz-Garzon and Pilar Fernandez-Calle and Abdurrahman Coskun and Bartlett, {William A.} and Massimo Locatelli and Anna Carobene",

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year = "2024",

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doi = "10.1016/j.cca.2024.117806",

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Itkonen, O, Jonker, N, Aarsand, AK, Sandberg, S, Diaz-Garzon, J, Fernandez-Calle, P, Coskun, A, Bartlett, WA, Locatelli, M & Carobene, A 2024, 'The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men', Clinica Chimica Acta, vol. 555, 117806. https://doi.org/10.1016/j.cca.2024.117806

The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men. / Itkonen, Outi (Lead / Corresponding author); Jonker, Niels; Aarsand, Aasne K et al.
In: Clinica Chimica Acta, Vol. 555, 117806, 01.03.2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The European Biological Variation Study (EuBIVAS)

T2 - Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men

AU - Itkonen, Outi

AU - Jonker, Niels

AU - Aarsand, Aasne K

AU - Sandberg, Sverre

AU - Diaz-Garzon, Jorge

AU - Fernandez-Calle, Pilar

AU - Coskun, Abdurrahman

AU - Bartlett, William A.

AU - Locatelli, Massimo

AU - Carobene, Anna

PY - 2024/3/1

Y1 - 2024/3/1

N2 - BACKGROUND: Knowledge of biological variation (BV) of hormones is essential for interpretation of laboratory tests and for diagnostics of endocrinological and reproductive diseases. There is a lack of robust BV data for many hormones in men.METHODS: We used serum samples collected weekly over 10 weeks from the European Biological Variation Study (EuBIVAS) to determine BV of testosterone, follicle-stimulating hormone (FSH), prolactin, luteinizing hormone (LH) and dehydroepiandrosterone sulfate (DHEA-S) in 38 men. We derived within-subject (CVI) and between-subject (CVG) BV estimates by CV-ANOVA after trend, outlier, and homogeneity analysis and calculated reference change values, index of individuality (II), and analytical performance specifications.RESULTS: The CVI estimates were 10 % for testosterone, 8 % for FSH, 13 % for prolactin, 22 % for LH, and 9 % for DHEA-S, respectively. The IIs ranged between 0.14 for FSH to 0.66 for LH, indicating high individuality.CONCLUSIONS: In this study, we have used samples from the highly powered EuBIVAS study to derive BV estimates for testosterone, FSH, prolactin, LH and DHEA-S in men. Our data confirm previously published BV estimates of testosterone, FSH and LH. For prolactin and DHEA-S BV data for men are reported for the first time.

AB - BACKGROUND: Knowledge of biological variation (BV) of hormones is essential for interpretation of laboratory tests and for diagnostics of endocrinological and reproductive diseases. There is a lack of robust BV data for many hormones in men.METHODS: We used serum samples collected weekly over 10 weeks from the European Biological Variation Study (EuBIVAS) to determine BV of testosterone, follicle-stimulating hormone (FSH), prolactin, luteinizing hormone (LH) and dehydroepiandrosterone sulfate (DHEA-S) in 38 men. We derived within-subject (CVI) and between-subject (CVG) BV estimates by CV-ANOVA after trend, outlier, and homogeneity analysis and calculated reference change values, index of individuality (II), and analytical performance specifications.RESULTS: The CVI estimates were 10 % for testosterone, 8 % for FSH, 13 % for prolactin, 22 % for LH, and 9 % for DHEA-S, respectively. The IIs ranged between 0.14 for FSH to 0.66 for LH, indicating high individuality.CONCLUSIONS: In this study, we have used samples from the highly powered EuBIVAS study to derive BV estimates for testosterone, FSH, prolactin, LH and DHEA-S in men. Our data confirm previously published BV estimates of testosterone, FSH and LH. For prolactin and DHEA-S BV data for men are reported for the first time.

KW - Biological variation

KW - Clinical interpretation

KW - EuBIVAS

KW - Hormones

KW - Laboratory medicine

KW - Reference change value

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U2 - 10.1016/j.cca.2024.117806

DO - 10.1016/j.cca.2024.117806

M3 - Article

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SN - 0009-8981

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JO - Clinica Chimica Acta

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Itkonen O, Jonker N, Aarsand AK, Sandberg S, Diaz-Garzon J, Fernandez-Calle P et al. The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men. Clinica Chimica Acta. 2024 Mar 1;555:117806. Epub 2024 Feb 9. doi: 10.1016/j.cca.2024.117806

The European Biological Variation Study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men

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Corrigendum to “The European biological variation study (EuBIVAS): Biological variation data for testosterone, follicle stimulating hormone, prolactin, luteinizing hormone and dehydroepiandrosterone sulfate in men” [Clin. Chim. Acta 555 (2024) 117806]

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