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Test ID: Testosterone
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Testosterone
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Useful For
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Diagnosis of hypogonadism, erectile dysfunction and infertility in men; in females, to evaluate hirsutism, virilization, infertility and polycystic ovary syndrome (PCOS), in children, to investigate puberty and development related issues.
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Method name and description
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Electrochemiluminescence Immunoassay (ECLIA)
Electrochemiluminescence immunoassay (ECLIA) intended for use on the cobas e 801 immunoassay analyzer. Patient specimen with a biotinylated monoclonal testosterone‑specific antibody, after addition of streptavidin-coated microparticles and a testosterone derivate labeled with a ruthenium complex, the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument specifically generated by 2‑point calibration and a master curve.
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Clinical information
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Testosterone is regarded as one of the key androgen steroids secreted from the testis and the adrenal cortex in men and from the adrenal cortex and the ovary in women. Most of the circulating testosterone is bound to carrier proteins (SHBG = sex hormone‑binding globulin). In men, testosterone promotes the development of the secondary sex characteristics, such as the growth of pubic, facial, and axillary hair, or the accessory sex organs. In women, androgens have no specific effects in women in terms of physiological concentrations. Increased production of testosterone in women can cause virilization.
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Specimen type / Specimen volume / Specimen container
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Specimen type: Serum, Plasma
Minimum volume of sample: 1 mL
Serum: Plain tube (red or yellow top)
Plasma: Li‑heparin tube
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Collection instructions / Special Precautions / Timing of collection
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Collect blood by standard venipuncture techniques as per specimen requirements. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
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Storage and transport instructions
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Storage: 5 days at 20 – 25°C
14 days at 2 – 8°C
6 months at ‑20 °C (± 5 °C)
Transport: 2-25°C
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Specimen Rejection Criteria
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Grossly hemolyzed, icteric and lipemic samples, wrong collection container, insufficient sample and heat‑inactivated samples.
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Biological reference intervals and clinical decision values
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Sex
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Age
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Reference interval (nmol/L)
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From
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To
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Male
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0 minutes
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1 year
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0.07 - 0.34
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Male
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1 year
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5 years
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0.07 - 0.39
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Male
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5 years
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10 years
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0.07 - 0.82
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Male
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10 years
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15 years
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0.07- 28.80
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Male
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15 years
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18 years
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6.4 – 30.7
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Male
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18 years
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40 years
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10.4 – 37.4
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Male
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40 years
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59 years
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10.4 – 30.9
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Male
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> 60 years
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10.4 - 25
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Female
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0 minutes
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1 year
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0.07 - 0.70
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Female
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1year
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5 years
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0.07 -0.39
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Female
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5 Years
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10 Years
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0.07 - 0.82
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Female
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10 Years
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20 Years
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0.07 - 2.72
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Female
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20 years
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49 years
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0.29 - 1.67
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Female
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> 50 years
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0.10 - 1.42
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Free and bioavailable testosterone will be done as a reflex testing for Male 20-65 years, if the testosterone result is between 8-12 nmol/l, and for Female if testosterone result is more than 3 nmol/l.
Free testosterone, calculated (FTc)
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Age (Male)
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(FTc) Reference interval (nmol/L)
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20‑49 years
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0.198-0.619
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≥ 50 years
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0.163-0.473
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Age (Female)
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(FTc) Reference interval (nmol/L)
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20‑49 years
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0.003-0.033
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≥ 50 years
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0.001-0.020
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Bioavailable testosterone, calculated (BATc)
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Age (Male)
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(BATc) Reference interval (nmol/L)
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20‑49 years
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4.36-14.3
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≥ 50 years
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3.59-11.0
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Age (Female)
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(BATc) Reference interval (nmol/L)
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20‑49 years
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0.059-0.756
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≥ 50 years
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0.030-0.430
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Note:
Free and bioavailable testosterone is not calculated for pediatrics, age < 20-year, Male > 65 year and the Testosterone result < 8 nmol/l or > 12 nmol/L
Free and bioavailable testosterone calculation depend on the Testosterone result (nmol/L) and SHBG result (nmol/L) with fixed value of Albumin 40 g/L
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Turnaround time / Days and times test performed / Specimen retention time
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Daily (24/7)
Turn-around time:
Routine: One working day
Specimen Retention: 4 days
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