Athlete Biological Passport - Administrative & Technical version

The questions and answers (Q&As) below complete the general Athlete Biological Passport (ABP) Q&A published on WADA’s website and address technical questions raised by Anti-Doping Organizations (ADOs) in relation to the ABP Steroidal Module.

Questions for ADOs’ ABP management

  1. How can ADOs access the ABP Steroidal Module in WADA’s Anti-Doping Administration and Management System (ADAMS)?
  2. How can ADOs set up the ABP Steroidal Module in ADAMS?
  3. What is a Passport Custodian?
  4. Can Passport custody be shared?
  5. Who is responsible for an Athlete’s Passport when the Athlete is under the jurisdiction of several ADOs?
  6. Which organization can use the steroidal data available in ADAMS?
  7. What happens if a national level Athlete does not have a NADO or his/her NADO does not use ADAMS?
  8. What happens if an IF was given custody of a national level Athlete for whom they wish to transfer that custody?
  9. What do WADA and ADOs/Experts/APMUs/Athletes/National Federations (if granted access by their IF) see in ADAMS?
  10. Can a Haematological Passport Expert be allowed by his/her ADO to look at a Steroidal Passport?
  11. Is there an accreditation system for APMUs?
  12. What happens to urine Samples analyzed prior to the ABP Steroidal Module launched on January 1, 2014?
  13. If an ADO contracts an APMU after January 1, 2014, will the Samples analyzed between January 1, 2014 and the start of the contract be included in the Steroidal Passport?
  14. Do all Samples and Passports need to be evaluated by an APMU (either in-house or laboratory-associated)?
  15. What is an “Atypical” Steroidal Passport (ATPF)?
  16. Can there be an Adverse Analytical Finding (AAF) directly from the Passport and, if so, what process is followed?
  17. What happens when the IRMS is negative or inconclusive?
  18. Who is the Results Management Authority (RMA)?
  19. Can an ADO conduct an IRMS analysis without an ATPF first being reported?
  20. How have the pre-conditions for an IRMS analysis changed for ADOs as of January 1, 2014?
  21. If an athlete has previously demonstrated a consistently high T/E ratio prior to January 1st, 2014, and his first urine sample will likely trigger a “suspicious profile”, should IRMS still be performed?
  22. Is there any specific requirement associated with the urine sample collection process as regards to alcohol consumption?
  23. What are the changes in the ABP Guidelines 5.0?
  24. Can analyses from non-WADA-accredited laboratories (clinical labs or private facilities) be used as part of the ABP?

Questions on Steroidal Module for Laboratories

  1. How is the “steroid profile” reported?
  2. What factors would invalidate the “steroid profile” in a sample?
  3. How will be the “steroid profile” reported if the Laboratory cannot measure (quantify) a specific marker of the profile, for example testosterone.
  4. Why are the Laboratories recommended to test, for example, for ethanol metabolite(s) and ketoconazole during the Confirmation Procedure, and not during the initial testing (screening) procedure?
  5. What is an Atypical Passport Finding (ATPF) in a “steroid profile”? What would trigger an ATPF?
  6. What are the consequences of an ATPF?
  7. What is the difference between an “ATPF Confirmation Procedure Request” and a “Suspicious Steroid Profile Confirmation Procedure Request”? What should the Anti-doping Laboratories do in each case?
  8. What happens if the ADO does not use ADAMS?
  9. How should the sample be reported if, in the Laboratory’s opinion, the “steroid profile” of the sample as determined during the Initial Testing Procedure looks suspicious?
  10. When should the Laboratory perform IRMS confirmation analyses?
  11. Can Laboratories perform IRMS and GC-MSn Confirmation Procedures immediately if the sample’s profile meets the criteria of a “suspicious steroid profile” as described in the TD2014EAAS (e.g. T/E > 4; T or E > 200 ng/mL in males or > 50 ng/mL in females; A
  12. How are the results of the IRMS confirmation analyses reported?
  13. Why is a quantification of the relevant marker of an atypical “steroid profile” required in addition to the IRMS confirmation analysis for an ATPF?
  14. What happens if an ATPF for the “steroid profile” is not confirmed by a positive IRMS result?
  15. Can a sample with an apparently normal “steroid profile” be subjected to IRMS confirmation analysis? What happens if the IRMS analysis is positive?
  16. What happens with the “longitudinal steroid profile” of an athlete if he/she is sanctioned for an anti-doping rule violation?

Questions for ADOs’ ABP management

1. How can ADOs access the ABP Steroidal Module in WADA’s Anti-Doping Administration and Management System (ADAMS)? Up

The ABP Haematological and Steroidal Modules can be accessed from the “Athlete tree” in ADAMS. The User account must be configured by the organization’s ADAMS Administrator. A Passport branch is available to Users with the relevant permissions once the appropriate setup has been completed.

See ADAMS Biological Passport Guide

2. How can ADOs set up the ABP Steroidal Module in ADAMS? Up

For detailed information, please consult ADAMS Steroidal Passport Setup.

3. What is a Passport Custodian? Up

Each Athlete already tested for the steroidal or haematological passport has a Passport Custodian in ADAMS. The Passport Custodian is responsible for sharing Passport information with other ADOs to ensure proper coordination and best use of resource expenditure. In the case of an Atypical Passport Finding (ATPF), the Passport Custodian is responsible for results management via its Athlete Passport Management Unit (APMU). From ADAMS release 3.7 (August 2014), the Passport Custodian is attributed to the Testing Authority that first tests the Athlete, independently of whether it is an ABP haematological or steroidal test or both.

The Passport Custodian can grant “read access” to other ADOs and can transfer the Passport custody of the Athlete to another organization upon agreement.

Please refer to ADAMS Passport Custodian for more information.

4. Can Passport custody be shared? Up

No. Passport custody cannot be shared, it can only be transferred. Only one ADO, the Passport Custodian, has the ultimate responsibility of evaluating and managing the passport for a particular athlete. However, ADOs are encouraged to share “read access,” communicate with each other about Athlete testing strategies and follow up on cases where appropriate. 

5. Who is responsible for an Athlete’s Passport when the Athlete is under the jurisdiction of several ADOs? Up

(e.g. two IFs when an Athlete competes in aquatics and triathlon, or an IF and two National Anti-Doping Organizations [NADOs], when the Athlete lives in one country and trains in another)

There can only be a single Passport Custodian responsible for results management. When an Athlete profile is created by an ADO in ADAMS, the first ADO who tested the Athlete becomes the Passport Custodian. Transfer of custody to the other IF, or to one of the relevant NADOs, is possible at any time.

Should a Major Event Organization (MEO) be the first ADO to create an Athlete’s profile in ADAMS, custodianship will be attributed to the relevant IF as an MEO cannot be the Passport Custodian. A transfer of custodianship by the IF to another ADO will be possible.

When the Athlete is first tested by a NADO, which does not match the Athlete’s sport nationality, the Passport custody is attributed to IF.

6. Which organization can use the steroidal data available in ADAMS? Up

If the Passport Custodian signs a sharing agreement with other ADOs, the ADO which is not the Passport Custodian can have “read access” to the data and use it for target testing purposes. 

7. What happens if a national level Athlete does not have a NADO or his/her NADO does not use ADAMS? Up

If the Athlete has been tested by a NADO that does not use ADAMS, no Passport will be created, as the Laboratory result will not be matched to a doping control form (DCF) and custody will be irrelevant. However, the NADO will remain responsible for conducting appropriate results management when relevant.

8. What happens if an IF was given custody of a national level Athlete for whom they wish to transfer that custody? Up

The IF may transfer custody to the relevant NADO. In the unlikely instance where no agreement can be reached over who should be the Passport Custodian, WADA may mediate. 

9. What do WADA and ADOs/Experts/APMUs/Athletes/National Federations (if granted access by their IF) see in ADAMS? Up

Please consult ADAMS Introduction.

10. Can a Haematological Passport Expert be allowed by his/her ADO to look at a Steroidal Passport? Up

No. Haematological Experts are allowed to see only Haematological Passports, and Steroidal Experts are allowed to see only Steroidal Passports.

APMUs have access to the ABP module(s) in which they specialize, and can share pertinent information with the members of their panel of Experts.

11. Is there an accreditation system for APMUs? Up

At present, there is no accreditation required for APMUs. APMUs are typically a part of WADA Accredited Laboratories or Code signatory ADOs. More information about APMUs can be found in the general ABP Q&As available on WADA’s Web site.

12. What happens to urine Samples analyzed prior to the ABP Steroidal Module launched on January 1, 2014? Up

All Samples received by a WADA Accredited Laboratory before January 1, 2014, cannot be included in the Passport.

Laboratory reporting requirements are in effect since January 1, 2014, and the Adaptive Model only considers Samples that have been analyzed and reported in a standardized way.

All ADOs that have already been involved in longitudinal steroid profiling may still open cases based on the previous WADA Technical Document (TD2004EAAS).

13. If an ADO contracts an APMU after January 1, 2014, will the Samples analyzed between January 1, 2014 and the start of the contract be included in the Steroidal Passport? Up

Yes, all data that have been entered into ADAMS by the Laboratories after January 1, 2014, will be included in the Steroidal Passport. However the ADO and the APMU will have to come to a financial agreement if there is a discrepancy between the start date of the contract and the evaluation of complete profiles that include Samples from an earlier date.

14. Do all Samples and Passports need to be evaluated by an APMU (either in-house or laboratory-associated)? Up

All Atypical Passport Findings (ATPFs) must be evaluated with the appropriate follow-up (e.g. IRMS, expert evaluation, further testing). For Passports that are not atypical, it is recommended that the number of Passports to be evaluated be in accordance with the risk assessment and available resources as part of the overall test distribution planning process. Individual contracts between ADOs and lab APMUs should be negotiated based on the volume and scope of the expected Passport review. 

15. What is an “Atypical” Steroidal Passport (ATPF)? Up

A Steroidal Passport is deemed atypical when the resulting longitudinal T/E profile or a particular T/E value is unlikely to be a result of normal physiological fluctuation, as calculated by the Adaptive Model. Plans are underway to enable declaring an ATPF based on other variables of the steroid profile than the T/E alone (e.g. A/T androsterone/testosterone).

16. Can there be an Adverse Analytical Finding (AAF) directly from the Passport and, if so, what process is followed? Up

No. However, in the case of an ATPF, a Confirmation Procedure including an Isotope Ratio Mass Spectrometry (IRMS) analysis will be performed automatically by the Laboratory responsible for the analysis of the Sample.

If the IRMS is positive (i.e. the exogenous origin of the steroid and an ATPF are confirmed), the outcome of the analysis becomes an AAF, with the Testing Authority responsible for the results management process and for taking a subsequent decision.

17. What happens when the IRMS is negative or inconclusive? Up

If the IRMS is negative or inconclusive (i.e. the exogenous origin of the steroid is not confirmed), then the APMU of the Passport Custodian must seek an Expert Review. (See OG Appendix E: TD2015 RMR, p. 45) The APMU will then determine the subsequent measures to take (i.e. more testing, case to open, etc.).

18. Who is the Results Management Authority (RMA)? Up

For an Atypical Passport which leads to a ‘positive’ IRMS (AAF), the RMA is the same as it would be for a traditional adverse finding. For cases however where IRMS is negative or inconclusive but expert evaluation of the Athlete’s Passport determines that the Athlete is likely doping, the RMA will be the Passport Custodian which is to be determined for all athletes in advance of testing. The RMA in this instance may well be managing a case where tests from multiple TAs contributed to the Athlete’s Passport.

19. Can an ADO conduct an IRMS analysis without an ATPF first being reported? Up

Yes, there can be circumstances in which an IRMS may be requested by an ADO, despite the fact that there is no ATPF. This could be based on recommendations from the laboratory or APMU, or information gathered from intelligence. The same process mentioned under Question 15 and in the Technical Document (OG Appendix E: TD2015 RMR) would apply.  In summary, although the Adaptive Model may trigger an ATPF and a mandatory IRMS analysis, an IRMS can still be performed at any time. 

20. How have the pre-conditions for an IRMS analysis changed for ADOs as of January 1, 2014? Up

As of January 1, 2014, rather than relying only on a > 4:1 T/E ratio, Laboratories now automatically perform a Confirmation Procedure (including an IRMS analysis) for each ATPF found by the Adaptive Model. This confirmation analysis is carried out automatically (i.e. regardless of whether the Athlete is known to have a naturally elevated T/E ratio in pre-2014 Samples) where IRMS analysis showed no evidence of exogenous administration before January 1, 2014.

The application of the Adaptive Model ensures an efficient screening of atypical profiles by minimizing the number of IRMS analyses of Samples collected on clean Athletes, while at the same time, maximizing the sensitivity to steroid doping.

If the Laboratory results cannot be included in the Athlete’s Passport and processed by the Adaptive Model for any reason, such as the fact that no DCF was entered in ADAMS an IRMS analysis will be performed where any of the following conditions is met:

  • T/E (testosterone/epitestosterone) ratio greater than 4.0;
  • Concentration of T or E is greater than 200 ng/mL in males or greater than 50 ng/mL in females; or
  • Concentration of A (androsterone) or Etio (etiocholanolone) is greater than 10,000 ng/mL combined with a ratio of A/Etio lower than 0.4 in males or greater than 4 in either sex.

Note that ADOs are afforded up to 14 calendar days from the time of the sample reception at a laboratory before they need to enter the DCF into ADAMS. If no match is made within this period, the laboratory will contact the TA who may be able to justify that the Confirmation Procedure is not necessary based, for example, on previous test results gathered on the same athlete.

21. If an athlete has previously demonstrated a consistently high T/E ratio prior to January 1st, 2014, and his first urine sample will likely trigger a “suspicious profile”, should IRMS still be performed? Up

Yes. In order to establish a robust steroid passport it is advisable that this first sample be sent for IRMS. This will insure that such cases of elevated T/E ratios are indeed natural. For subsequent samples, the adaptive model will be applied based on this athletes own T/E ratio and will not trigger an IRMS request.

If the TA justifies that confirmation is not necessary, based on solid evidence establishing a consistently elevated T/E ratio and at least one negative IRMS procedure on a sample with elevated T/E ratio, it is still recommended to store suspicious samples for possible future analysis. The Laboratory shall update the ADAMS report for the Sample with a comment stating that the TA considered that the Confirmation Procedure(s) were not necessary, and the explanation provided by the TA.

22. Is there any specific requirement associated with the urine sample collection process as regards to alcohol consumption? Up

It is not recommended to have alcohol available in Doping Control Stations, nor should it ever be offered by a Doping Control Officer, however there is no need to report on the Doping Control Form whether or not alcohol has been consumed by the athlete.

23. What are the changes in the ABP Guidelines 5.0? Up

The major changes in the revised ABP Guidelines are, 1) to formally introduce the concept of the Passport Custodian. 2) to update the TD2014EAAS to 2.0, and 3) to update other technical documents to be compatible to the new TD2014EAAS.

The changes made in the Guidelines will not affect the already existing sharing agreement.

Please refer the summary of modifications for the further details.

24. Can analyses from non-WADA-accredited laboratories (clinical labs or private facilities) be used as part of the ABP? Up

Analysis of blood parameters when conducted as part of the ABP  is performed in a standardized manner according to strict protocols in collection, transport and laboratory analysis. The protocols used for analysis in other settings, such as clinical labs or private facilities, may differ from those used in WADA-accredited labs and may therefore yield results that are not identical. For this reason, samples not analyzed by WADA-accredited labs or that don’t follow the ABP technical protocols for collection and transport cannot be included in the Athlete Biological Passport.

Questions on Steroidal Module for Laboratories

1. How is the “steroid profile” reported? Up

The “steroid profile” should be reported for every urine sample following the performance of the Initial Testing (screening) Procedure. Laboratories currently report in ADAMS the T/E ratio and the concentrations of the six markers of the “steroid profile” (Testosterone, Epitestosterone, Androsterone, Etiocholanolone, 5αAdiol and 5βAdiol). Other urinary steroids, or ratios of steroid metabolites, are also useful in evaluating a “steroid profile” (e.g. A/T, A/Etio, 5αAdiol/5βAdiol, 5αAdiol/E). These additional ratios are computed in ADAMS after the reporting of the “steroid profile” by the Laboratory.

The values of the “steroid profile” from the Initial Testing Procedure of each sample collected from an athlete are then included in the athlete’s Steroidal Passport.

2. What factors would invalidate the “steroid profile” in a sample? Up

The Laboratory will report the “steroid profile” for a sample as “invalid” if any factor which may alter the “steroid profile” is detected during the Initial Testing Procedure (as per TD2014EAAS v2.0). These factors include, for example, the detection of other anabolic steroids (e.g. stanozolol), human chorionic gonadotrophin (hCG) in males, inhibitors of 5α-reductase such as finasteride, or signs of microbial contamination (e.g. presence of 5α- and 5β-androstanedione or 4-androstenedione). These requirements may undergo revision by the LabEG in collaboration with ABP and Laboratory experts. In addition, the “steroid profile” will be reported as invalid if the Laboratory cannot measure the T/E ratio of the sample from the ratio of the corrected chromatographic peak areas or peak heights (and in such cases the T/E ratio will be reported as “-1”).

3. How will be the “steroid profile” reported if the Laboratory cannot measure (quantify) a specific marker of the profile, for example testosterone. Up

When the Laboratory cannot measure the concentration of a specific marker of the “steroid profile”, even after repetition of sample analysis if possible, the Laboratory will report the concentration of this non-measurable marker as “-1”. However, this will not necessarily invalidate the “steroid profile”, even if the affected marker(s) is, for example, testosterone and/or epitestosterone: as long as the T/E ratio can be measured from the ratio of the corrected chromatographic peak areas or peak heights, the T/E value will be reported and the “steroid profile” will be considered as valid.

4. Why are the Laboratories recommended to test, for example, for ethanol metabolite(s) and ketoconazole during the Confirmation Procedure, and not during the initial testing (screening) procedure? Up

The detection of elevated quantities of ethanol metabolites or ketoconazole during the Initial Testing Procedure would lead to the immediate invalidation of the sample’s “steroid profile”. Not being prohibited substances (with the exception of ethanol in specific sports), the detection of these substances would not constitute an Adverse Analytical Finding and would not have negative consequences for the athlete. Therefore, their induced invalidation of the “steroid profile” could be “legitimately” used to mask doping with EAAS. However, these substances do not affect the results of IRMS confirmation analyses.

Therefore, in order to avoid their use as masking agents, it is recommended that IRMS confirmation analyses are conducted on samples with these potentially altered “steroid profiles”, and that determination of ethanol metabolites and ketoconazole be performed in parallel during Confirmation Procedures. In case of negative or inconclusive IRMS results, the detection of these substances may explain the origin of the altered profile. However, positive IRMS results will serve to pursue an anti-doping rule violation against the athlete, irrespective of the presence in the sample of ethanol metabolites or ketoconazole.

5. What is an Atypical Passport Finding (ATPF) in a “steroid profile”? What would trigger an ATPF? Up

As soon as the Laboratory results for the sample’s “steroid profile” are matched with a Doping Control Form (DCF) in ADAMS, they are analyzed with the help of a mathematical model, the Adaptive Model, which calculates the 99% probability that values of the “steroid profile” are consistent with a normal physiological condition of the athlete. Any values falling outside these physiological probability limits are flagged by the Adaptive Model as abnormal. Although the Adaptive Model is applied to the four ratios T/E, A/T, A/Etio and 5αAdiol/5βAdiol with the results added to the athlete’s passport, an ATPF is only declared in case of an atypically high T/E value. An ATPF indicates the possibility of doping with synthetic forms of endogenous anabolic androgenic steroids (EAAS), such as testosterone, its precursors (e.g. DHEA) or active metabolite (DHT), as well as indirect forms of steroid doping, such as aromatase inhibitors. While the model does not allow for the direct detection of a particular prohibited substance, it permits establishing that the alteration of the “steroid profile” is the result of doping.

6. What are the consequences of an ATPF? Up

When the ATPF is the result of an abnormally high T/E, this ATPF triggers the performance of Confirmation Procedures, including IRMS analysis and the quantification (by GC-MS or GC-MS/MS) of the relevant marker of the “steroid profile”. An ATPF can also be used to apply intelligent target testing of the athlete on a longitudinal basis. Ultimately, an ATPF may constitute the basis to pursue an anti-doping rule violation against the athlete.

7. What is the difference between an “ATPF Confirmation Procedure Request” and a “Suspicious Steroid Profile Confirmation Procedure Request”? What should the Anti-doping Laboratories do in each case? Up

Upon reporting by Laboratories of “steroid profiles” in ADAMS following the ITP on the A sample, two kinds of notifications may be automatically generated by ADAMS: 1) an “ATPF Confirmation Procedure Request” notification, or 2) a “Suspicious Steroid Profile Confirmation Procedure Request” notification.

The conditions that would trigger either kind of notification are briefly outlined below:

• “ATPF Confirmation Procedure Request”: Laboratories will receive an immediate “ATPF Confirmation Procedure Request” from ADAMS if i) the sample is matched to a DCF in ADAMS, AND ii) it does not constitute the first steroidal passport test sample of the athlete, AND iii) if, following the application of the Adaptive Model, it is determined that the T/E value is abnormally high, OR iv) if some steroid concentration values in the sample are abnormal as compared with reference population values (e.g. concentration of T or E > 200 ng/mL in males or > 50 ng/mL in females).

When receiving an “ATPF Confirmation Procedure Request”, the Laboratories shall proceed to performing IRMS and GC-MSn confirmation analyses immediately, at the cost of the responsible Testing Authority (TA).

• “Suspicious Steroid Profile Confirmation Procedure Request”: Alternatively, Laboratories will receive an automatic ADAMS “Suspicious Steroid Profile Confirmation Procedure Request” notification within 14 calendar days after the sample reception date (“Date Received by Lab” in ADAMS), if i) that sample is not matched to a DCF in ADAMS (for example, when Testing Authorities do not use ADAMS or do not input athletes’ DCF information in ADAMS), OR ii) if it is the athlete’s first steroidal passport test, AND iii) if the T/E value is greater than 4.0, OR if the sample meets any of the concentration criteria listed in section 3.0 of the Technical Document on Endogenous Anabolic Androgenic Steroids - Measurement and Reporting (TD2014EAAS v2.0), e.g. concentration of T or E > 200 ng/mL in males or > 50 ng/mL in females. When receiving a “Suspicious Steroid Profile Confirmation Procedure Request” notification, Laboratories will contact the TA and proceed with a Confirmation Procedure that includes an IRMS analysis at the TA’s costs, unless the TA can justify within seven days that the Confirmation Procedure is not necessary.

• In addition to the two automatic notifications through ADAMS, Laboratories may at any time advise the TA to perform IRMS analyses based upon their expertise and perform the confirmation if authorized by the TA (regardless of receiving an ADAMS notification). In some instances, Laboratories may have contractual agreements in place with the TA allowing them to perform IRMS analyses immediately on any samples that they would consider suspicious.

8. What happens if the ADO does not use ADAMS? Up

If the DCFs are not entered in ADAMS, the sample’s results reported by the Laboratory cannot be matched to a particular athlete and, therefore, the “steroid profile” for the sample cannot be entered into the athlete’s passport and processed by the Adaptive Model in ADAMS. As a consequence, ADAMS automatically applies less cost-efficient rules to trigger IRMS analyses (e.g. T/E > 4.0). The Laboratory then proceeds to perform the Confirmation Procedures if the criteria as described in section 3.0 of the TD2014EAAS v2.0 are met; for example, all samples with T/E > 4.0 with no matched DCF in ADAMs will trigger an automatic “Suspicious Steroid Profile Confirmation Procedure Request” notification. These IRMS analyses are mandatory except when the ADO can show that the apparently abnormal “steroid profile” is the result of a normal physiological condition for that particular athlete (for example, if the ADO has previous longitudinal “steroid profile” information on the athlete showing that the values in the sample are within the athlete’s normal physiological limits).

The detrimental consequences for ADOs that do not utilize ADAMS are twofold:

1. ADOs are unable to build athlete steroid profiles that consist of results from tests conducted by multiple agencies; and

2. ADOs are likely be required to conduct more IRMS analyses, as the T/E ratio greater than 4.0 is a less refined predictor of possible doping than the Adaptive Model available in ADAMS.

9. How should the sample be reported if, in the Laboratory’s opinion, the “steroid profile” of the sample as determined during the Initial Testing Procedure looks suspicious? Up

The Laboratory should report the values of the “steroid profile” as determined from the Initial Testing Procedure in ADAMS, and report the sample in accordance with the results of the analyses performed so far, for example, as “Negative” (No Prohibited Substance(s) or Metabolite(s) or Marker(s) of a Prohibited Method(s) on the test menu were detected) if no prohibited substance or prohibited method was detected in the sample, or as “Adverse Analytical Finding” or “Atypical Finding” if applicable to the “A” sample Confirmation Procedure for a particular prohibited substance or prohibited method.

Laboratories shall not directly report findings for T/E > 4.0 as Atypical Findings any more, but should report the Test Result as “Negative” if no other findings are associated with the sample analysis. The application of the Adaptive Model in ADAMS to the sample’s “steroid profile” will determine if the elevated T/E ratio constitutes an ATPF or, alternatively, if the Adaptive Model cannot be applied, if it meets the conditions of a “suspicious steroid profile” (which will be applicable to T/E > 4.0). In either case the Laboratory will receive an automatic confirmation request from ADAMS to proceed to confirmation analyses. The Laboratory will then update the Test Result status of the sample in ADAMS on the basis of the results of the Confirmation Procedures for the “steroid profile” (i.e. IRMS).

Occasionally, however, Laboratories may perform IRMS confirmation analyses before the reporting of the “steroid profile” from the Initial Testing Procedure in ADAMS. For example, Laboratories may have contractual agreements in place with the TA allowing them to perform IRMS analyses immediately on any samples that they would consider suspicious. In such cases, the Laboratory may directly proceed to perform the IRMS and GC-MSn confirmation analyses on the samples, and then report in ADAMS the values of the “steroid profile” as determined in the Initial Testing Procedure, the confirmed relevant values of the “steroid profile” (both for IRMS and GC-MSn) and report the sample in accordance with the results of the IRMS Confirmation Procedure, as set out in the Technical Document for Detection of Synthetic Forms of Endogenous Anabolic Androgenic Steroids by GC-C-IRMS (TD2014IRMS). When the Laboratories have already performed IRMS analyses and reported their results in ADAMS, they will not receive a confirmation request notification from ADAMS.

10. When should the Laboratory perform IRMS confirmation analyses? Up

  1. IRMS analysis is mandatory by TD2014EAAS upon reception of an “ATPF Confirmation Procedure Request” notification through ADAMS.
  2. Upon reception of the “Suspicious Profile Confirmation Request” notification, the Laboratory shall proceed with the Confirmation Procedure(s) unless, after contacting the TA, the TA can justify within 7 calendar days that the Confirmation Procedure(s) is not necessary. If the TA justifies that confirmation is not necessary, the Laboratory shall update the ADAMS report for the Sample with a comment stating that the TA considered that the Confirmation Procedure(s) were not necessary, and the explanation provided by the TA. If the TA cannot justify that confirmation is not necessary, the Laboratory shall proceed with the confirmation analyses and subsequently update the ADAMS record for the Sample based on the results of the Confirmation Procedure(s) (refer to the TDIRMS [1]).
  3. Laboratory may also perform IRMS analyses on the basis of an existing contractual agreement with the TA, or when requested by the TA, the Athlete Passport Management Unit (APMU) or WADA.

11. Can Laboratories perform IRMS and GC-MSn Confirmation Procedures immediately if the sample’s profile meets the criteria of a “suspicious steroid profile” as described in the TD2014EAAS (e.g. T/E > 4; T or E > 200 ng/mL in males or > 50 ng/mL in females; A Up

In principle, Laboratories shall report the values of the “steroid profile”, as determined during the Initial Testing Procedure, in ADAMS and wait to receive an “ATPF Confirmation Procedure Request” (immediately upon reporting) or a “Suspicious Steroid Profile Confirmation Procedure Request” (within 14 calendar days after reception of the sample in by the Laboratory) from ADAMS, as applicable. This is particularly important for T/E > 4.0 because if the Adaptive Model cannot be applied to process the sample’s profile, following the reception of the “Suspicious Steroid Profile Confirmation Procedure Request” the Laboratory will have to contact the TA before proceeding with the Confirmation Procedures.

However, Laboratories will (always) either receive an “ATPF Confirmation Procedure Request” (if the Adaptive Model can be applied) or a “Suspicious Steroid Profile Confirmation Procedure Request” (if the Adaptive Model cannot be applied) when samples meet any of the concentration criteria of a “suspicious profile” (i.e. for extreme values of T, E, A or Etio). Therefore, when samples with these characteristics are detected, and if the immediate “ATPF Confirmation Procedure Request” is not received from ADAMS upon reporting the sample’s “steroid profile”, Laboratories may choose to not wait for the 14-day “Suspicious Steroid Profile Confirmation Procedure Request” but instead contact the TA immediately to communicate that they will proceed with the Confirmation Procedures on the sample. This would avoid waiting unnecessarily until the “Suspicious Steroid Profile Confirmation Procedure Request” is received, which may be important, for example, for in-competition testing during major events that require a fast turnaround of laboratory results.

As noted, Laboratories may also have contractual agreements in place with the TA allowing them to perform IRMS analyses immediately on any samples that they would consider suspicious.

12. How are the results of the IRMS confirmation analyses reported? Up

As set out in the TD2014IRMS, IRMS results shall be performed as part of the Confirmation Procedure and reported as “Adverse Analytical Finding” (for positive IRMS results), “Atypical Finding” (for inconclusive IRMS results) or “No Prohibited Substance(s) or Metabolite(s) or Marker(s) of a Prohibited Method(s) on the test menu were detected” (for negative IRMS results). Before reporting an “Adverse Analytical Finding” for the IRMS, the Laboratory should seek a second opinion of an expert from another WADA-accredited Laboratory.

13. Why is a quantification of the relevant marker of an atypical “steroid profile” required in addition to the IRMS confirmation analysis for an ATPF? Up

The IRMS and GC-MS or GC-MS/MS methods provide independent and complementary information. For example, values for marker(s) of the “steroid profile” may be outside the subject-based longitudinal reference range while being of endogenous origin (e.g. microbial formation of free testosterone). On the other hand, the “steroid profile” may be altered by the administration of a steroid preparation which may not be detected by IRMS. The confirmed value of the ATPF constitutes a verified evidence of an altered “steroid profile”, to be considered by the Expert Panel and the APMU during the results management process.

14. What happens if an ATPF for the “steroid profile” is not confirmed by a positive IRMS result? Up

An ATPF for the “steroid profile” may result from the administration of a steroid preparation which may not be detected by IRMS. In such cases, all the information regarding the specific ATPF (e.g. values of the profile, presence of any factors which could have altered the profile), as well as the “longitudinal steroid profile” of the athlete, if available, will be considered by the Expert Panel when analyzing whether the ATPF could be used to pursue an anti-doping rule violation against the athlete.

15. Can a sample with an apparently normal “steroid profile” be subjected to IRMS confirmation analysis? What happens if the IRMS analysis is positive? Up

Yes, a sample may be subjected to IRMS analysis at any time, for example if requested by the TA, the APMU or WADA. In case of a positive result, the sample will be reported as an Adverse Analytical Finding and a usual results management process will follow.

16. What happens with the “longitudinal steroid profile” of an athlete if he/she is sanctioned for an anti-doping rule violation? Up

When an athlete is sanctioned for an anti-doping rule violation based on a substance or method that is known to affect the “steroid profile”, his/her Steroidal Passport is reset, i.e. a new Steroidal Passport will be created when new doping control samples are collected once the athlete finishes the period of ineligibility.