Oxis International Inc. - Testosterone ELISA

Home \| Product Overview

Format page for printing

Testosterone Enzyme Immunoassay

Catalog Number: 11150

Enzyme Immunoassay for the Quantitative Determination of Testosterone Concentration in Human Serum

**For research use only. Not for use in diagnostic procedures.**

View Product Insert
(Problems downloading insert? Click here)

Introduction:

Introduction: Testosterone (17?-hydroxyandrost-4-ene-3-one) is a C19 steroid with an unsaturated bond between C-4 and C-5, a ketone group in C-3 and a hydroxyl group in the ? position at C-17. This steroid hormone has a molecular weight of 288.4. Testosterone is the most important androgen secreted into the blood. In males, testosterone is secreted primarily by the Leydig cells of the testes; in females ca. 50% of circulating testosterone is derived from peripheral conversion of androstenedione, ca. 25% from the ovary and ca. 25% from the adrenal glands. Testosterone is responsible for the development of secondary male sex characteristics and its measurements are helpful in evaluating the hypogonadal states. In women, high levels of testosterone are generally found in hirsutism and virilization, polycystic ovaries, ovarian tumors, adrenal tumors and adrenal hyperplasia. In men, high levels of testosterone are associated to the hypothalamic pituitary unit diseases, testicular tumors, congenital adrenal hyperplasia and prostate cancer. Low levels of testosterone can be found in patients with the following diseases: Hypopituitarism, Klinefelter?s syndrome, Testicular feminization, Orchidectomy and Cryptorchidism, enzymatic defects and some autoimmune diseases. The Testosterone EIA kits are designed for the measurement of total Testosterone in human serum.

Application:

Clinical Application: (Information is cited from reference # 7)

In Male:
In man, the determination of testosterone is used as an indicator for the function of the testes: low hormone levels are found in cases with Klinefelter's syndrome, cryptorchism or anorchia. Male with testosterone deficiency often present with a number of symptoms such as decreased libido, as well as decreased muscle strength, gynecomastia and infertility.

In Female:

Virilizing Disorders:
Testosterone measurements are frequently utilized in the evaluation of virilizing disorders. Testosterone concentrations >2.0 ng/ml may indicate androgen secreting ovarian or adrenal neoplasms.
Monitoring of Androgen Suppressing Drugs:
Testosterone measurements may be utilized in women for the adjustment of androgen suppressing drugs and their dosages.
Pregnancy:
Testosterone concentrations are relatively consistent during the pregnancy.

Safety:

Test methods are not available which can offer complete assurance that Hepatitis B virus, Human Immunodeficiency Virus (HIV/HTLVIII/ LAV), or other infectious agents are absent from the reagents in this kit. Therefore, all human blood products, including patient samples, should be considered potentially infectious. Handling and disposal should be in accordance with the procedures defined by an appropriate national biohazard safety guideline or regulation, where it exists (e.g., USA Center for Disease Control/National Institute of Health Manual,

Curve:

Results of a typical standard run with optical density readings at 450 nm shown in the Y axis against Testosterone concentrations shown in the X axis. Note: This standard curve is for the purpose of illustration only, and should not be used to calculate unknowns. Each laboratory must provide its own data and standard curve in each experiment.

Testosterone (ng/ml)	Absorbance (450 nm)
0	3.096
0.1	2.700
0.5	2.185
2.0	1.709
6.0	1.105
18.0	0.516

Sensitivity:

The minimum detectable concentration of the Oxis Testosterone ELISA assay as measured by 2 SD from the mean of a zero standard is estimated to be 0.05 ng/ml.

Performance:

Good laboratory practice requires that controls are run with each calibration curve. A statistically significant number of controls should be assayed to establish mean values and acceptable ranges to assure proper performance. We recommend using Bio-Rad Lyphochek Immunoassay Control Sera as controls. The Testosterone EIA kit also provides with internal controls, Level 1 and 2.

Storage:

Unopened test kits should be stored at 2-8 degrees C.

Kit Contents:

MATERIALS PROVIDED WITH THE KIT:

Goat Anti-Rabbit IgG-coated microtiter wells, 96 wells
Testosterone Reference Standards: 0, 0.1, 0.5, 2.0, 6.0 and 18.0 ng/ml. Liquids, 0.5 ml each, ready to use.
Rabbit Anti-Testosterone Reagent (pink color), 7 ml
Testosterone-HRP Conjugate Reagent (blue color), 12 ml
Testosterone Control 1, Liquid, 0.5 ml, Ready to use.
Testosterone Control 2, Liquid, 0.5 ml, Ready to use.
TMB Reagent (One-Step) 11 ml.
Stop Solution (1N HCl), 11 ml.

MATERIALS REQUIRED BUT NOT PROVIDED:

Precision pipettes: 10

Instrumentation:

A microtiter plate reader with a bandwidth of 10 nm or less and an optical density range of 0-3 O.D. at 450 nm wavelength is acceptable for use in absorbance measurement.

Assay Precision:

a. Intra-Assay Precision Within-run precision was determined by replicate determinations of four different serum samples in one assay. Within-assay variability is shown below:

Samples	1	2	3	4
# Replicates	24	24	24	24
Mean Testosterone (ng/ml)	0.44	3.7	5.1	12.7
S.D.	0.03	0.4	0.4	0.6
C.V. (%)	6.4	10.0	8.3	5.0

b. Inter-Assay Precision Between-run precision was determined by replicate measurements of six different serum samples over a series of individually calibrated assays. Between-assay variability is shown below:

Samples	1	2	3	4
# Replicates	20	20	20	20
Mean Testosterone (ng/ml)	0.45	3.4	5.0	13.3
S.D.	0.02	0.3	0.2	0.5
C.V. (%)	4.4	8.4	4.4	3.7

References

View Product References