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Importance of total and measured free testosterone in diagnosis of male hypogonadism: immunoassay versus mass spectrometry in a population of healthy young/middle-aged blood donors

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Abstract

Purpose

To meet clinicians’ request for adequate results and reliable reference ranges for testosterone, this study was planned with the aims (i) to verify the reliability of the reference interval for total testosterone (TT) declared by immunoassay manufacturer and adopted by laboratory, (ii) to compare results for serum TT obtained by immunoassay and LC–MS/MS and (iii) to verify if the cutoff values for low TT and measured free testosterone (FT), defined by Endocrine Society Guidelines for diagnosis of hypogonadism, are applicable to our study group.

Methods

Sera from anonymous young/middle-aged male blood donors were selected for the study. TT was measured by immunoassay and LC–MS/MS. SHBG was measured by immunoassay and used with albumin concentration to calculate FT according to Vermeulen’s formula.

Results

The reference interval declared by the manufacturer and adopted by the lab was validated. The two methods for TT evaluation correlated very well. TT and FT lower limits at 5th and 2.5th percentile are below the cutoffs reported in the literature for the diagnosis of hypogonadism.

Conclusions

The immunoassay currently used in our lab can be considered an adequate tool for TT, but it’s essential that clinical data agree with the biochemical ones, particularly in the presence of TT values between the lower limit of reference range and the cutoff values recommended by scientific societies.

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Authors and Affiliations

  1. Laboratory of Chemistry and Endocrinology, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy

    P. Agretti, C. Pelosini, L. Bianchi, A. Del Grosso & M. R. Sessa

  2. Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Via Savi 10, 56126, Pisa, Italy

    A. Saba

  3. Laboratory of Clinical Pathology, University Hospital of Pisa, Via Roma 67, 56126, Pisa, Italy

    A. Saba

  4. Endocrinology Unit, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy

    D. Canale

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  1. P. Agretti
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  2. C. Pelosini
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  3. L. Bianchi
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  4. A. Del Grosso
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  5. A. Saba
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  7. M. R. Sessa
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Correspondence to P. Agretti.

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The study have been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Agretti, P., Pelosini, C., Bianchi, L. et al. Importance of total and measured free testosterone in diagnosis of male hypogonadism: immunoassay versus mass spectrometry in a population of healthy young/middle-aged blood donors. J Endocrinol Invest 44, 321–326 (2021). https://doi.org/10.1007/s40618-020-01304-7

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  • DOI: https://doi.org/10.1007/s40618-020-01304-7

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