In 2009, WADA released the first version of the Athlete Biological Passport Operating Guidelines (ABP Guidelines), which introduced a standardized approach to the profiling of individual Athlete haematological variables (the ‘Haematological Module’).
Since then, the Athlete Biological Passport (ABP) has been successfully integrated into the anti-doping strategies of numerous International Federation (IF) and National Anti-Doping Agency (NADO) programs, resulting in countless targeted adverse analytical findings (AAFs) and many direct Anti-Doping Rule Violations (ADRVs).
This notice is intended to update the anti-doping community on the status of the ABP and the Steroidal Module, which took effect since January 2014.
At WADA’s Executive Committee Meeting September 11, 2013, a new Technical Document (TD) on the Measurement and Reporting of Endogenous Anabolic Androgenic Steroids for Laboratories was approved. This technical document (TD2014EAAS) came into force January 2014, and set the stage for the introduction of the new ABP Steroidal Module.
Accordingly, ABP Operating Guidelines were revised by WADA to account for this new TD, which was a pre-condition for the launch of the Steroidal Module. The Operating Guidelines provide guidance on the optimal way to implement this new anti-doping tool.
Enhancements to the existing Guidelines bring modest changes to existing mandatory documents on Sample collection, transportation of Samples and results management. The revised TDs were tabled for approval at WADA’s Executive Committee Meeting in November, and take effect January 1, 2014.
Following four month operation of the Steroidal Module and feedback from the stakeholders, TD2014EAAS was revised and submitted for approval to the WADA’s Executive Committee Meeting in May. TD2014EAAS 2.0 takes effects on September 1st, 2014.
To address immediate questions that Athletes and the anti-doping community at large may have about the ABP Steroidal Module, please see the following series of questions and answers.
WADA continues to keep all stakeholders apprised of ABP developments, and provide new resources to support implementation.
If the Q&As below did not address your questions, please feel free to contact us:
- What are the differences between the Haematological and the Steroidal Modules?
- What are the benefits of the Steroidal Module?
- Is the Guideline for the Reporting and Management of Elevated T/E Ratios and Endogenous Steroids still applicable?
- For which athletes should an ADO use the Steroidal Module?
- What are the requirements to run a Steroidal Passport Program?
- What is included in a steroid profile?
- How are anonymous tests matched to a specific athlete’s Steroidal Passport?
- How many values/samples are necessary for the Steroidal Passport?
- What is an Atypical Passport Finding (ATPF) and how is it generated?
- What happens if an ADO does not engage or possess an APMU?
- What if an ADO does not use ADAMS?
- Which laboratories do measure steroid profiles?
- Do ADOs bear any additional costs to implement the Steroidal Module bear any additional costs?
The Haematological Module monitors an athlete’s unique haematological (blood) variables over time that may be indicative of the effects of blood doping, such as blood transfusions or the use of Erytrhopoiesis-Stimulating Agents (ESAs). These haematological variables form a `blood profile´ that is measured from an athlete’s blood samples.
The Steroidal Module monitors an athlete’s steroidal variables over time that may be indicative of steroid abuse. These steroidal variables form a `steroid profile´ that is established from an athlete’s urine samples.
The primary benefit to all anti-doping organizations (ADOs) is that the steroidal data and automation in ADAMS alerts ADOs to those athletes who may be cheating, and provides intelligence from urine samples already being collected that can improve the effectiveness of any anti-doping program.
From 2004 to 2013, isotope ratio mass spectrometry (IRMS) analysis was required when an Athlete had a T/E ratio greater than 4:1. The Adaptive Model used by the Athlete Biological Passport (ABP) replaces this ‘population reference’ approach with an ‘intra-individual’ approach, which allows for a more refined evaluation.
With the Haematological Module, when an atypical Athlete Passport is identified, an automated notification is sent to the ADO’s Athlete Passport Management Unit (APMU) by ADAMS, and the APMU is required to evaluate the Passport. (For more information on APMUs, please refer to the General Q&A on the ABP). With the Steroidal Module, IRMS analysis is conducted as a first step, and evaluation by experts required only when the IRMS is negative or inconclusive.
The costs to ADOs should eventually drop as more of the process is automated within ADAMS and the IRMS confirmation is applied on a more appropriate personalized approach.
3. Is the Guideline for the Reporting and Management of Elevated T/E Ratios and Endogenous Steroids still applicable? Up
WADA accredited laboratories and ADOs need to follow the new Technical Document on Anabolic Steroids (TD2014EAAS2.0).
All athletes automatically have a Steroidal Passport as the steroid profile is measured in all urine samples and the Adaptive Model applied to every steroid profile.
There are two main requirements to run a Steroidal Passport Program:
- To enter the DCFs in ADAMS for every collected urine sample;
- To have an APMU, ideally associated to a WADA accredited laboratory, for the management of the Steroidal Passport Program.
A steroid profile is measured on all urine samples. It consists of the urinary concentrations of Testosterone, Epitestosterone, Androsterone, Etiocholanolone, 5a-androstane-3a,17β-diol and 5β-androstane-3a,17β-diol, together with the specific gravity of the urine sample. The steroid profile is reported in ADAMS by WADA accredited laboratories for all urine samples. Further ratios are calculated to detect multiple forms of steroid doping.
When doping controls are performed, the authorizing agency (Testing Authority or Sample Collection Authority) must enter the doping control forms (DCFs) into ADAMS. The DCFs and the laboratory results are matched automatically by ADAMS and the new steroid profile collated in the athlete’s Passport. The athlete is assigned a Biological Passport Identification Code (BP ID) to maintain anonymity within the system.
By definition, any athlete that has a urine test and its corresponding DCF entered into ADAMS has a Steroidal Passport. A single test may be sufficient either for targeting purposes or to prompt IRMS confirmation, although generally two or three urine tests are necessary for a longitudinal analysis.
As soon as the Laboratory Results are matched with a DCF in ADAMS, the Adaptive Model is automatically applied to detect Atypical Passport Findings(ATPFs). The Adaptive Model is an algorithm that calculates whether the result, or results over time in the case of a longitudinal profile, is likely the result of a normal physiological condition. An Atypical Passport Finding (ATPF) is generated in ADAMS if the athlete’s T/E ratio is out of the individual range generated by the Adaptive Model to a specificity of 99%. An Atypical Passport Finding (ATPF) requires further investigation.
If for some reason, the ADO has not already engaged an APMU, and an Atypical Passport Finding (ATPF) is reported with a negative or inconclusive IRMS, then the responsible ADO should seek further guidance from the laboratory that performed the analysis. Further investigation and/or analysis are required.
If the DCFs are not entered in ADAMS, ADAMS automatically applies less cost-efficient rules to trigger IRMS analyses. These IRMS analyses are mandatory except when the ADO can show that the steroid profile is the result of a normal physiological condition.
When the sample cannot be processed by the Adaptive Model in ADAMS (i.e. because no DCF was entered, and the Sample remains unmatched to the result that has been entered by the laboratory), the laboratory receives an automatic notification from ADAMS 14 calendar days after sample reception.
The laboratory then proceeds to a confirmation procedure if the criteria as described in article 3.0 of the TD2014EAAS are met (> 4:1 T:E ratio). The laboratory subsequently contacts the Testing Authority to inform it of plans to proceed to IRMS unless the Testing Authority can justify to the laboratory and WADA that the confirmation procedure(s) is/are not necessary.
The detrimental consequences for ADOs that do not utilize ADAMS are twofold:
- ADOs are unable to build athlete steroid profiles that consist of results from tests conducted by multiple agencies; and
- ADOs are likely be required to conduct more IRMS analyses, as the 4:1 ratio is a less refined predictor of possible doping than the Adaptive Model available in ADAMS.
13. Do ADOs bear any additional costs to implement the Steroidal Module bear any additional costs? Up
If implemented in accordance with the ABP Operating Guidelines, the Steroidal Module has negligible additional costs. On the contrary it improves the cost-effectiveness of testing programs by enabling a more refined approach to IRMS analysis. Urine samples are already being collected, and the Steroidal Module offers greater intelligence for each sample – beyond it being merely ‘negative’ or ‘positive.’
APMU engagement and evaluations, as well as expert reviews (when necessary), are the only new costs. If the risk of steroid abuse is low in a sport, it is highly unlikely that the longitudinal profile results in an Atypical Passport Finding (ATPF) and thus need further evaluation. Although costs may vary, WADA is working closely with laboratory-based APMUs to develop a transparent process for the aforementioned costs.
If an Atypical Passport Finding (ATPF) is reported with a negative or inconclusive IRMS and the APMU experts nevertheless believe there is a high likelihood of doping, there may be a recommendation to proceed to a results management process. These costs are variable, as with any form results management.