Exceptional diagnostics
for reproductive disease state management.
Access Testosterone
Chemistry
Lab Automation
Information Systems
Molecular Diagnostics
Immunodiagnostics
Centrifugation
Disease Management
Hematology
Hemostasis
Flow Cytometry
Primary Care
Testosterone plays a key role in health, wellbeing and sexual function in both men and
women. Increased levels of testosterone lead to
enhanced libido, increased energy, increased
production of red blood cells and protection
against osteoporosis. Testosterone is the
primary sex steroid hormone in males and one
of the androgens. It is primarily produced and
secreted by the testes in males, the ovaries in
females and a small amount by the adrenal
glands in both sexes.
Testosterone Ratios in Males and Females1,2
When assessing a patient’s androgen status,
testosterone levels may be used in conjunction
with sex hormone binding globulin (SHBG)
levels to provide free androgen index as well as
calculated free and bioavailable testosterone
measurements.
Access Testosterone offers:
• 16 minute time to first result—reduces critical
waiting time for physicians and patients
• Competitive dynamic range (0.1 – 16 ng/mL
or 0.35 - 55.5 nmol/L)—reduces the need for
sample dilution and saves time
• Serum and heparinized plasma are
compatible with the assay—provides testing
flexibility
DS-12798A
Access Testosterone
Expected Values
Testosterone levels were measured in human serum and heparinized plasma from apparently healthy male and
female patients using the Access Testosterone assay. The observed ranges of testosterone concentrations are
shown below for each population represented. The data is representative; each laboratory should establish its
own reference ranges to assure proper representation of specific populations and sample types.
Reference Group & Age
Range
Males (18 – 66 years)
Females (21 – 73 years)
Sample Type
n
Median
Concentration
ng/mL (nmol/L)
95% Reference
Interval
ng/mL (nmol/L)
Serum
240
3.84 (13.32)
1.75 – 7.81 (6.07 - 27.10)
Plasma
(heparinized)
240
3.84 (13.32)
1.68 – 7.58 (5.83 - 26.30)
Serum
240
0.29 (1.01)
< 0.1 – 0.75 (<0.35 - 2.60)
Plasma
(heparinized)
240
0.41 (1.42)
< 0.1 – 0.90 (<0.35 - 3.12)
Ordering Information
Characteristics
Sample Type / Size
Serum or plasma (heparinized) / 20 µL
Reagent Kit (2 x 50 tests)
33560
Time to First Result
16 minutes
Calibrators (6 vials or 2.5 mL)
33565
Analytical Sensitivity
0.1 ng/mL (0.35 nmol/L)
Approximate
Calibrator Levels
0, 0.5, 1.5, 4.0, 8.0 and 16.0 ng/mL
(1.7, 5.2, 13.9, 27.8 and 55.5 nmol/L)
References
Reportable Range
0.1 – 16 ng/mL (0.35 – 55.5 nmol/L)
Open Pack Stability
28 days
2. Dunn JF, Nisula BC, Rodbard D. Transport of steroid hormones:
binding of 21 endogenous steroids to both testosterone-binding
globulin and corticosteroid-binding globulin in human plasma.
J Clin Endocrinol Metab 1981;53(1):58-68
Calibration Stability
14 days
Precision
≤ 20% at 0.5 ng/mL and < 10% from 2 – 10 ng/mL
(≤ 20% at 1.74 nmol/L and < 10% from 6.94 – 34.70 nmol/L)
1. Selby C. Sex hormone binding globulin: origin, function and
clinical significance. Ann Clin Biochem 1990; 27: 532-41.
Access Reproductive: A Menu that Matters
AFP (ONTD)
DHEA-S
Estradiol
hFSH
hLH
Inhibin A
Progesterone
Prolactin
SHBG
Testosterone
Total βhCG
Ultrasensitive Estradiol*
Unconjugated Estriol
Access reproductive solutions are part of a comprehensive assay menu featured on Access and
UniCel Immunoassay Systems. To learn more, visit www.beckmancoulter.com/reproductive.
Space for
FSC Logo
*In development
Not all assays are available in all countries.
Beckman Coulter, the stylized logo, Access and UniCel are registered trademarks of Beckman Coulter, Inc.
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