Testosterone in Human Serum with Roche e801
Detection of Testosterone in Human Serum with Roche e801
| Test Name: | This immunoassay is for the in vitro quantitative determination of testosterone in human serum and plasma. |
| Method Name: | In the Elecsys TESTO assay, a TESTO specific antibody labeled with a ruthenium complex is used to determine the testosterone concentration. |
| Results: | Technical Range: 2.50-1500 ng/dL Reportable Range: 3.05-1340 ng/dL |
| Reference Ranges: | Pediatric Males and Females by age: MALES ng/dL 2-10 <8-31 11 <8-321 12 <8-531 13 <8-609 14 23-652 15 126-792 16-17 116-779 FEMALE ng/dL 2-10 <8-80 11-15 < 8-49 16-17 20-56 Pediatric Males and Females by Tanner Stage: MALES ng/dL Tanner Stage 1 < 8-64 Tanner Stage 2 < 8-166 Tanner Stage 3 < 8-609 Tanner Stage 4 43-756 T anner Stage 5 66-841 FEMALES ng/dL Tanner Stage 1 < 8 – 79 Tanner Stage 2 < 8 – 45 Tanner Stage 3 < 8 – 49 Tanner Stage 4 8 – 54 Tanner Stage 5 14 – 71 Adult Male Testosterone (ng/dL) 18 -39 years 264-916 40 – 49 years 232-928 50- 59 years 210-962 60 – 69 years 234-990 70 – 79 years 167-895 Adult Female Testosterone (ng/dL) Pre-menopausal 9-53 Post – menopausal <8-48 |
| Clinical Significance: | Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The androgen testosterone (17β hydroxyandrostenone) has a molecular weight of 288 daltons. In men, testosterone is synthesized almost exclusively by the Leydig cells of the testes. The secretion of testosterone is regulated by luteinizing hormone (LH) and is subject to negative feedback via the pituitary and hypothalamus. Testosterone promotes the development of the secondary sex characteristics in men and serves to maintain the function of the prostate and seminal vesicles. Most of the circulating testosterone is bound to carrier proteins (SHBG, sex hormone binding globulin). In women, small quantities of testosterone are formed in the ovaries. In physiological concentrations, androgens have no specific effects in women. Increased production of testosterone in women can cause virilization (depending on the increase). The Elecsys Testosterone II assay is based on a competitive test principle using a high affinity monoclonal antibody (sheep) specifically directed against testosterone. Endogenous testosterone released from the sample by 2 bromoestradiol competes with the added testosterone derivative labeled with a ruthenium complex for the binding sites on the biotinylated antibody. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes. |
| Submission Criteria: | For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable. The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer. |
| Rejection Criteria: | Rejection criteria include but are not limited to: 1. Specimens containing fibrin or clots. 2. Excessive platelet clumping 3. Leaking specimens 4. Substandard mixing or collection 5. Expired or improperly stored collection tubes. 6. Improperly filled tubes based on collection tube manufacturer’s guidelines. 7. Contaminated specimens (IV fluid, foreign particles, etc.) 8. Specimens not analyzed within the appropriate time frame. 9. Samples not shipped at appropriate temperature. 10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition. |
| Authorization: | Diagnostic testing can only be performed with approval from an authorized provider/agency. |
| Turn Around Time: | 1 day. |
