It is recommended that a urine Sample in which any one of the following criteria is met during the
Screening Procedure, be routinely submitted to the IRMS analysis:
i) T/E value equal or greater than 4;
ii) concentration of testosterone or epitestosterone (equivalent to the glucuronide) greater than
200 ng/mL1;
iii) concentration of androsterone or etiocholanolone (equivalent to the glucuronide) greater than
10,000 ng/mL1;
iv) concentration of DHEA (equivalent to the glucuronide) greater than 100 ng/mL1.
It is recognised that other parameters may justify a need for IRMS study and the reason should be
documented.
Any result that will be used to support an Adverse Analytical Finding shall be confirmed and
quantified.
Confirmation of elevated T/E values, concentration of testosterone, epitestosterone or any other
steroid metabolite under consideration is to be performed in triplicate. The confirmation of the
identity of any steroid reported with abnormal properties must be made (refer to technical
document TD2003IDCR). Appropriate calibration (e.g. calibration curve, deuterated standards,
quality control samples) is to be included in the protocol of the Confirmation Procedure.
Confirmed elevated concentration of steroids will be reported as such together with the value
adjusted for the specific gravity of the urine Sample using the following formula:
Concentration1.020 ng/mL = (1.020 – 1) / (Specific gravity of the Sample– 1) • Concentration measured
ng/mL
The urine Sample is not collected under sterile conditions, and where the circumstances are
favourable, the microbes present in the Sample can cause changes to the profile of the urinary
steroids. Initially there is cleavage of the glucuronides and sulfates followed by modifications of
the steroids’ structure by oxido-reductive reactions. To report an Adverse Analytical Finding of an
elevated T/E value, testosterone or epitestosterone concentration or any other endogenous steroid
parameters, the concentration of free testosterone and/or epitestosterone in the specimen is not to
exceed 5% of the respective glucuroconjugates. Elevated amounts of 5a- and 5ß-androstan-3,17-
dione in the free form also indicate microbial degradation.