Dehydroepiandrosterone Sulfate (DHEA‑S) in Human Serum with Roche e801

Detection of Dehydroepiandrosterone Sulfate (DHEA‑S) in Human Serum with Roche e801

Test Name: Immunoassay for the in vitro quantitative determination of dehydroepiandrosterone sulfate (DHEA‑S) in human serum and plasma.
Method Name: The Elecsys DHEA‑S assay makes use of a competition test principle using a polyclonal antibody (rabbit) specifically directed against DHEA‑S. Endogenous DHEA‑S in the sample competes with added DHEA‑S derivative labeled with a ruthenium complex for the binding sites on the biotinylated antibody.
Results: Technical Range: 0.2-1000 µg/dL
Reportable Range: 0.247-759 µg/dL
Reference Ranges: MALES
1-14 days: DHEA-S levels in newborns are very elevated at birth but will fall to prepubertal levels within a few days.
Tanner Stages*
Mean Age Reference Range µg/dL
Stage I >14 days 11-120
Stage II 11.5 years 14-323
Stage III 13.6 years 5.5-312
Stage IV 15.1 years 29-412
Stage V 18.0 years 104-468
*Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for boys at a median age of 11.5 ± 2 years. For boys, there is no proven relationship between puberty onset and body weight or ethnic origin. Progression through Tanner stages is variable. Tanner stage V (adult) is usually reached by age 18.
18-30 years: 105-728 µg/dL
31-40 years: 57-522 µg/dL
41-50 years: 34-395 µg/dL
51-60 years: 20-299 µg/dL
61-70 years: 12-227 µg/dL
≥71 years: 6.6-162 µg/dL

FEMALES 1-14 days: DHEA-S levels in newborns are very elevated at birth but fall to prepubertal levels within a few days.
Tanner Stages*
Mean Age Reference Range (µg/dL)
Stage I >14 days 16-96
Stage II 10.5 years 22-184
Stage III 11.6 years 11-296
Stage IV 12.3 years 17-343
Stage V 14.5 years 57-395
*Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for girls at a median age of 10.5 ± 2 years. There is evidence that it may occur up to 1 year earlier in obese girls and in African American girls. Progression through Tanner stages is variable. Tanner stage V (adult) is usually reached by age 18.
18-30 years: 83-377 µg/dL
31-40 years: 45-295 µg/dL
41-50 years: 27-240 µg/dL
51-60 years: 16-195 µg/dL
61-70 years: 9.7-159 µg/dL
≥71 years: 5.3-124 µg/dL

Clinical Significance: DHEA‑S is a steroid hormone which is produced from the precursor cholesterol in the zona reticularis and broad fascia of the adrenal cortex. The determination of elevated DHEA‑S values is an important aid in the diagnosis of hirsutism and virilism. In addition to a differential diagnosis of hirsutism and virilism further indications for this parameter are all forms of androgenisation, hyperprolactinemia, polycystic ovarian syndrome, and the exclusion of an androgen producing tumor of the adrenal cortex. DHEA‑S exhibits only a weak androgenic activity but can be metabolized to more active androgens such as androstendione and testosterone, which can indirectly cause hirsutism and virilism.

From 7 years of age onwards, an increase in DHEA‑S levels is observed which then gradually after the age of 30 begins to fall again. Only elevated DHEA‑S concentrations are of clinical importance; other factors which can be responsible for DHEA‑S excess production are genetic enzyme defects of the adrenal cortex (adrenogenital syndrome), hyperplasia of the adrenal cortex as well as androgen producing tumors.

The rate of secretion of DHEA‑S into the blood stream is only slightly more than the rate observed for DHEA. Because of the DHEA‑S half‑life of approximately 1 day, the DHEA‑S level is however about a thousand-fold greater. DHEA‑S is relatively strongly bound to albumin, only a small portion is non-protein bound, and none appears to be bound to sex hormone‑binding globulin (SHBG). Due to its high concentration and low inter- and intra‑day variability, DHEA‑S is an excellent indicator of adrenal cortex androgen production.

Together with testosterone, DHEA‑S assays represent the assay of choice for initial screening tests to determine whether androgen values are elevated in hirsutism. Approximately 84 % of the women suffering from hirsutism exhibit elevated androgen levels. The main purpose of this is to exclude the presence of androgen producing tumors (from the adrenal cortex or the ovaries). Tumor relevant values in women are those values exceeding 700 µg/dL DHEA‑S.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

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.
Storage and Stability:    365 days at -20°C
14 days at 2-8°C
5 days at 20-25 °C

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.