Testosterone Test - Check Low / High Testosterone Levels (Sex Hormone)
Testosterone NormalwerteCoat-A-Count Free Testosterone is a solid-phase I radioimmunoassay designed anabolizantes the quantitative measurement of free testosterone in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis and normall of hirsutism due to hyperandrogenism. TKTF1 tubesTKTF2 tubes The tube kit contains bormal than 4 microcuries kilobecquerels of radioactive I-labeled testosterone analog; the tube kit normal free testosterone percentage less than 8 microcuries kilobecquerels. Summary and Explanation of normal free testosterone percentage Test Testosterone circulates almost entirely bound to transport proteins: The principal transport protein for testosterone is known as sex hormone binding globulin SHBG or testosterone-estradiol binding globulin TeBGsince it binds not only to testosterone but also to estradiol and dihydrotestosterone. Albumin and cortisol norjal globulin CBG are the other testosterone transport proteins.
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Coat-A-Count Free Testosterone is a solid-phase I radioimmunoassay designed for the quantitative measurement of free testosterone in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis and management of hirsutism due to hyperandrogenism. TKTF1 tubes , TKTF2 tubes The tube kit contains less than 4 microcuries kilobecquerels of radioactive I-labeled testosterone analog; the tube kit contains less than 8 microcuries kilobecquerels.
Summary and Explanation of the Test Testosterone circulates almost entirely bound to transport proteins: The principal transport protein for testosterone is known as sex hormone binding globulin SHBG or testosterone-estradiol binding globulin TeBG , since it binds not only to testosterone but also to estradiol and dihydrotestosterone. Albumin and cortisol binding globulin CBG are the other testosterone transport proteins. For three reasons, SHBG is the most important of these transport proteins.
It carries, at least in females, a higher percentage of the testosterone in circulation than either albumin or CBG. Furthermore, it binds to testosterone with a much higher affinity than do the other two transport proteins. The testosterone bound to albumin and CBG is collectively known as "weakly bound" testosterone. Finally, SHBG has a responsiveness, not associated with albumin, insofar as the SHBG level is sensitive to changes in the ratio of circulating estrogens to circulating androgens.
SHBG thus plays a greater role in determining the level of free testosterone in circulation. In pregnancy, SHBG levels show a progressive increase that mirrors the rise in estradiol levels. Although the total testosterone level also shows some increase during pregnancy, the rise in estradiol, and hence also in SHBG, is more dramatic.
The net result is a decrease in free testosterone as a percent of total testosterone. Women taking oral contraceptives likewise have increased SHBG levels, at least if they are taking high dose ethinyl estradiol preparations. Conversely, the administration of androgens to prepubertal boys, or the elevation of endogenous testosterone by HCG stimulation, induces a significant decrease in the SHBG level.
Obesity is also associated with a decrease in the SHBG level. Other things being equal, we expect the concentration of free testosterone in circulation to increase if the testosterone level T increases or if the SHBG level decreases. The Testosterone Free Index is often increased in severe acne, male androgenic alopecia balding , hirsutism and other conditions.
A low SHBG level, often in combination with a normal total testosterone level, is a common finding in these conditions. An increase in the testosterone production rate typically induces a decrease in the SHBG level.
This stimulates cellular uptake and metabolism of testosterone, by making more available in the free form. The result is that the total testosterone level is often normal, because the increased production rate is offset by an increased rate of clearance.
Total testosterone measurements have traditionally been used to help screen for hirsutism. In his study of 32 hirsute women, only 44 percent had elevated total testosterone levels, while all 32 had elevated free testosterone levels.
Not all investigators have achieved this degree of success. On balance, however, judging from the studies reviewed by Wu, it appears that free testosterone is at least marginally superior to total testosterone in this context.
The varied outcomes could possibly be due to differences in methodology and differences in the selection of patients. Principle of the Procedure In Coat-A-Count Free Testosterone procedure, I-labeled testosterone analog competes for a fixed time with free testosterone in the patient sample for sites on testosterone-specific antibody immobilized to the wall of a polypropylene tube.
The tube is then decanted, to isolate the antibody-bound fraction, and counted in a gamma counter, the counts being inversely related to the concentration of free testosterone in the sample. The assay is designed to leave essentially unchanged the original equilibrium between free and protein-bound testosterone in the patient sample. It employs a tracer which does not bind to steroid hormone transport proteins, and an antiserum with an affinity for testosterone slightly less than that of the principal transport protein, sex hormone-binding globulin SHBG.
Moreover, it operates under physiological conditions of temperature, ph and ionic strength. In this respect it differs from conventional equilibrium dialysis methods and from so-called testosterone free index TFI determinations. It is also a single-stage assay, requiring neither a pre-incubation step nor preliminary isolation of the free fraction by dialysis, filtration or column chromatography.
In addition, it has the following noteworthy features: Total counts at iodination: Store at 2 8 C in a refrigerator designated for incoming radioactive materials.
Dispose of in accordance with applicable laws. Do not use reagents beyond their expiration dates. Follow universal precautions, and handle all components as if capable of transmitting infectious agents. Source materials derived from human blood were tested and found nonreactive for syphilis; for antibodies to HIV 1 and 2; for hepatitis B surface antigen; and for antibodies to hepatitis C.
Sodium azide, at concentrations less than 0. On disposal, flush with large volumes of water to prevent the buildup of potentially explosive metal azides in lead and copper plumbing. Use distilled or deionized water. Radioactivity A copy of any radioisotope license certificate Specific or General issued to a US customer must be on file with Siemens Healthcare Diagnostics before kits or components containing radioactive material can be shipped.
These radioactive materials may be acquired by any customer with the appropriate Specific license. Under a General license these radioactive materials may be acquired only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories and hospitals and strictly for in vitro clinical or laboratory tests not involving external or internal administration of the radioactive material or its radiation to human beings or other animals.
Its acquisition, receipt, storage, use, transfer and disposal are all subject to the regulations and a General or Specific license of the U. Handle radioactive materials according to the requirements of your General or Specific license.
To minimize exposure to radiation, the user should adhere to guidelines set forth in the National Bureau of Standards publication on the Safe Handling of Radioactive Materials Handbook No. Wipe up spills promptly and decontaminate affected surfaces. Avoid generation of aerosols. Dispose of solid radioactive waste according to license requirements. General licensees holders of NRC Form may dispose of solid radioactive waste as nonradioactive waste, after removing labeling.
Licensees in Agreement States should refer to the appropriate regulations of their own state. General licensees may dispose of liquid radioactive waste of the type contained in this product through a laboratory sink drain. Licensees must remove or deface labels from empty containers of radioactive materials before disposal of solid waste.
Specific licensees may dispose of small quantities of liquid radioactive waste of the type used in this product through a laboratory sink drain. Refer to the appropriate regulations applicable to your laboratory.
Initial Preparation The materials supplied in this kit are not interchangeable with those in the Coat-A- Count Total Testosterone kit, which is designed for measuring total testosterone. Store refrigerated and protected from moisture, carefully resealing the bags after opening. Stable at 2 8 C until the expiration date marked on the bag. Stable at 2 8 C for 30 days after opening, or until the expiration date marked on the vial. Free Testosterone Calibrators TFC3 8 Six vials of free testosterone calibrators, ready-to-use, in processed human serum with preservatives sodium azide and gentamicin.
The zero calibrator vial A contains 2. Stable at 2 8 C for 30 days after opening. The calibrators have lot-specific free testosterone values of approximately 0, 0. FDR Logit-log graph paper A tri-level, human serum-based immunoassay control, containing testosterone as one of over 25 assayed constituents, is available from Siemens Healthcare Diagnostics catalog number: Specimen Collection The patient need not be fasting, and no special preparations are necessary.
Because EDTA would have a significant effect on results, it should not be used as an anticoagulant. Grossly lipemic serum samples may yield erroneously high free testosterone results. The use of an ultracentrifuge is recommended to clear lipemic samples. Hemolyzed samples may indicate mistreatment of a specimen before receipt by the laboratory; hence the results should be interpreted with caution.
Coat-A- Count Free Testosterone has not been tested with all possible variations of tube types. Consult the section on Alternate Sample Types for details on tubes that have been tested. Danazol, a derivative of the synthetic steroid ethisterone, is used in the treatment of endometeriosis and fibrocystic breast disease.
The androgenic side-effects have been attributed to the increased availability of free testosterone in patients undergoing Danazol therapy. Thus, patients taking Danazol will present with increased concentrations of free testosterone. In vitro studies with the Coat-A-Count Free Testosterone assay also show an increase in apparent free testosterone concentration in samples spiked with Danazol.
Therefore, caution must be exercised when interpreting free testosterone levels in patients who are undergoing Danazol therapy. Before assay, allow the samples to come to room temperature 15 28 C and mix by gentle swirling or inversion. Aliquot, if necessary, to avoid repeated thawing and freezing. Do not attempt to thaw frozen specimens by heating them in a waterbath.
Radioimmunoassay Procedure All components must be at room temperature 15 28 C before use. Label four plain uncoated 12x75 mm polypropylene tubes T total counts and NSB nonspecific binding in duplicate.
Because nonspecific binding in the Coat-A-Count procedure is characteristically low, the NSB tubes may be safely omitted without compromising accuracy or quality control.
Label additional antibodycoated tubes, also in duplicate, for controls and patient samples. The values of the calibrators are lot-specific. Pipet directly to the bottom. Do not attempt to dilute patient samples expected to contain high concentrations in the zero calibrator. Since dilution shifts the equilibrium between free and bound testosterone, the assay system cannot be expected to maintain linearity under dilution.
It is good practice to use a disposabletip micropipet, changing the tip between samples, in order to avoid carryover contamination. No more than 10 minutes should elapse during the dispensing of the tracer. Set the T tubes aside for counting at step 6 ; they require no further processing. The rack should be covered with Parafilm to prevent evaporation. Removing all visible moisture will greatly enhance precision. Using a foam decanting rack, decant or aspirate the contents of all tubes except the T tubes and allow them to drain for 2 or 3 minutes.
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