Establishing normal values of total testosterone in adult healthy men by the use of four immunometric methods and liquid chromatography-mass spectrometry.
- Montagna G Department of Obstetrics and Gynecology, University Hospital Basel, Basel, Switzerland.
- Balestra S Department of Laboratory Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland.
- D'Aurizio F Clinical Pathology Institute, University Hospital Udine, Udine, Italy.
- Romanelli F Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
- Benagli C Department of Laboratory Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland.
- Tozzoli R Clinical Pathology Service, Regional Hospital, Pordenone, Italy.
- Risch L Labormedizinisches Zentrum Dr. Risch, Liebefeld, Switzerland.
- Giovanella L Clinic for Nuclear Medicine and PET/CT Centre, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
- Imperiali M Department of Laboratory Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland.
- 2018-05-11
Published in:
- Clinical chemistry and laboratory medicine. - 2018
age
body mass index
late-onset hypogonadism (LOH)
reference ranges
testosterone
Adolescent
Adult
Body Mass Index
Chromatography, High Pressure Liquid
Healthy Volunteers
Humans
Immunoassay
Male
Reagent Kits, Diagnostic
Reference Values
Tandem Mass Spectrometry
Testosterone
Young Adult
English
BACKGROUND
The total testosterone (T) cutoffs clinically adopted to define late-onset hypogonadism (LOH) do not consider the differences that exist between different analytical platforms, nor do they consider the body mass index (BMI) or age of the patient. We aimed at providing method, age and BMI-specific normal values for total T in European healthy men.
METHODS
A total of 351 eugonadal healthy men were recruited, and total T was measured with four automated immunometric assays (IMAs): ARCHITECT i1000SR (Abbott), UniCel DxI800 (Beckman Coulter), Cobas e601 (Roche), IMMULITE 2000 (Siemens) and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reference ranges (RRs) were calculated for each method.
RESULTS
Passing and Bablok regression analysis and Bland-Altman plot showed an acceptable agreement between Abbott and LC-MS/MS, but a poor one between LC-MS/MS and the other IMAs. Age-specific T concentrations in non-obese (BMI <29.9 kg/m2) men were greater than in all men. The total T normal range, in non-obese men aged 18-39 years, measured with LC-MS/MS was 9.038-41.310 nmol/L. RRs calculated with LC-MS/MS statistically differed from the ones calculated with all individual IMAs, except Abbott and among all IMAs. Statistically significant differences for both upper and lower reference limits between our RRs and the ones provided by the manufacturers were also noticed.
CONCLUSIONS
We calculated normal ranges in a non-obese cohort of European men, aged 18-39 years, with four commercially available IMAs and LC-MS/MS and found statistically significant differences according to the analytical method used. Method-specific reference values can increase the accuracy of LOH diagnosis and should be standardly used.
The total testosterone (T) cutoffs clinically adopted to define late-onset hypogonadism (LOH) do not consider the differences that exist between different analytical platforms, nor do they consider the body mass index (BMI) or age of the patient. We aimed at providing method, age and BMI-specific normal values for total T in European healthy men.
METHODS
A total of 351 eugonadal healthy men were recruited, and total T was measured with four automated immunometric assays (IMAs): ARCHITECT i1000SR (Abbott), UniCel DxI800 (Beckman Coulter), Cobas e601 (Roche), IMMULITE 2000 (Siemens) and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reference ranges (RRs) were calculated for each method.
RESULTS
Passing and Bablok regression analysis and Bland-Altman plot showed an acceptable agreement between Abbott and LC-MS/MS, but a poor one between LC-MS/MS and the other IMAs. Age-specific T concentrations in non-obese (BMI <29.9 kg/m2) men were greater than in all men. The total T normal range, in non-obese men aged 18-39 years, measured with LC-MS/MS was 9.038-41.310 nmol/L. RRs calculated with LC-MS/MS statistically differed from the ones calculated with all individual IMAs, except Abbott and among all IMAs. Statistically significant differences for both upper and lower reference limits between our RRs and the ones provided by the manufacturers were also noticed.
CONCLUSIONS
We calculated normal ranges in a non-obese cohort of European men, aged 18-39 years, with four commercially available IMAs and LC-MS/MS and found statistically significant differences according to the analytical method used. Method-specific reference values can increase the accuracy of LOH diagnosis and should be standardly used.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1515/cclm-2017-1201
- PMID 29746252
- Persistent URL
- https://sonar.ch/global/documents/232304
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