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• For the Endocrine Module, an example of this approach could be the application of the hGH Isoform Differential Immunoassay to Samples with atypical hGH Marker values.
b) Through changes in biological Markers of doping collated over time , a Passport can be used to establish ‘ Use’ per Code Article 2.2 without necessarily relying on traditional analytical approaches for the detection of a particular Prohibited Substance or Prohibited Method .
As some Prohibited Substances and Prohibited M ethods can be undetectable despite causing lasting physiological changes on the body, the ABP is a powerful and necessary tool to complement traditional analytical testing.
c) The ABP can also be used to assist investigations, for example by flagging Athletes and/or groups of Athletes for further investigation, or by providing complementary information during ongoing investigations.
In particular, as Marker data are linked to the time and location of Sample collection within the ABP, spatiotemporal analysis of suspicious Marker profiles can provide a rich dataset that can be merge d with other forms of intelligence.
d) The Steroidal Module of the ABP can assist in identifying the substitution of an Athlete’s urine Sample with the urine of another individual (urine exchange) .
When a urine Sample steroid profile is not consistent with other Sample (s) from the Athlete’s Passport , urine exchange may be suspected and confirmed using DNA analysis across multiple S amples , leading to an ADRV under Code Article 2.2 and/or 2.5 .
e) The ABP can be used by Anti-Doping Organizations (ADOs ) to help optimize their Test Distribution Plan and the cost efficiency of their overall Testing strategy .
For example, Passport status can be used as part of a larger risk assessment in order to flag Athletes , teams, sports or n ationalities requiring increased or decreased Testing frequency.
Passport status can also be used to select Samples for long- term storage.
f) The ABP is an effective doping deterrent that complements multi -faceted anti -doping program s by adding to aspects such as A thlete Education, whereabouts, traditional testing strategies and R esults Management thereby having the potential to improve deterrence of athletes and their entourage from engaging in doping behaviour.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 6/91 Part 2: Modules, Management and Administration 2.1.
Modules 2.1.1.
Hematological Module The Hematological Module collects information on Markers of blood doping.
This m odule aims to identify the Use of Prohibited Substances and/or Prohibited Methods for the enhancement of oxygen transport or delivery, including the Use of AAEs and any form of blood transfusion or manipulation.
In addition to identifying the use of A AEs included under section S2 of the Prohibited List (Peptide Hormones, Growth Factors , Related Substances , and Mimetics), the Hematological Module also seeks to identify the Use of Prohibited Methods categorized under section M1 of the Prohibited List (Manipulation of Blood and Blood Components).
The following blood variables are considered within the ABP Hematological Module: − ABPS: Abnormal blood profile score − HCT: Hematocrit − HGB : Hemoglobin − IRF: Immature reticulocyte fraction − MCH: Mean corpuscular hemoglobin − MCHC: Mean corpuscular hemoglobin concentration − MCV : Mean corpuscular volume − OFFS : OFF- score − PLT: Platelet count − RBC: Red blood cell (erythrocyte) count − RDW -SD: Red cell distribution width (standard deviation) − RET# : Reticulocyte s count − RET% : Reticulocytes percentage − WBC : White blood cells ABP Operating Guidelines – Version 9.0 – July 2023 Page 7/91 2.1.2.
Steroidal Module The Steroidal Module collects information on Markers of steroid doping measured in urine and/or serum Samples .
The module aims to identify endogenous anabolic androgenic steroids (EAAS) when administered exogenously.
The Steroidal Module i s also an effective means to identify urine Samples which may have been tampered with or exchanged with the urine of another individual.
The following urinary Markers are considered within the ABP Steroidal Module, as detailed in the Technical Document on Measurement and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS) Markers of the Urinary Steroid Profile (TD EAAS, see Section 3.
6 below): − A: Androsterone − Etio: Etiocholanolone (Etio) − 5αAdiol : 5α-Androstane- 3α,17β-diol − 5βAdiol : 5β-Androstane- 3α,17β-diol − T: Testosterone − E: Epitestosterone In addition to the following ratios: − T/E − A/T − A/Etio − 5αAdiol/5βAdiol − 5αAdiol/E As detailed in the Laboratory Guidelines for Quantification of Endogenous Steroids in Blood for the Athlete Biological Passport (see section 3.
5 below), one additional Marker and one ratio are considered in blood: − T: Testosterone − T/A4 : Ratio between the concentrations of Testosterone and Androstenedione (A4) 2.1.3.
Endocrine Module The Endocrine Module collects information on Markers of hGH doping.
The m odule aims to identify hGH use and as well as use of hGH analogs , fragments and releasing factors categorized under Section S 2.2 of the Prohibited List .
This module may also indicate use of insulin- like growth factor -I (IGF-I), categorized under Section S2.3 of the Prohibited List.
The following Markers are considered within the Endocrine Module, as detailed in the Laboratory Guidelines for the Analytical Requirements for the Endocrine Module of the Athlete Biological Passport (see Section 3.4 below): ABP Operating Guidelines – Version 9.0 – July 2023 Page 8/91 − GH-2000 Score − IGF-I: Insulin -like Growth Factor -I − P-III-NP: N-terminal Pro-peptide of T ype III C ollagen 2.2.
Resources, Partner Roles and Responsibilities The roles and responsibilities of the various partners involved in the ABP process include, in particular, test planning, conducting the Sample collection, Sample analysis, profile assessment and Results Management .
These activities are carried out through an administrative process involving the coordination of different stakeholder groups, namely ADOs , Laboratories , APMUs , and Experts .
Consequently, the success of an ABP program depends on the mutual recognition of stakeholder roles and the efficient exchange of relevant information between stakeholders involved in the ABP process .
2.2.1.
Resources The following resources are required to implement the ABP: − Dedicated resources within an ADO to effectively manage both testing and R esults Management requirements for the ABP, including the implementation of ABP- related requirements in the Technical Document for Sport Specific Analysis (TDSSA) .
− Access to a network of Doping Control Officers (DCOs ) and Blood Collection Officers (BCOs ) where necessary, operating in locations where target Athletes will be present , with access to materials requi red for collection and transport of ABP Samples .
− An effective whereabouts management system to facilitate Athlete location (i.e.
ADAMS).
− Access to ADAMS, to administer the ABP Program.
− Laboratories to analyse Samples and report the results into ADAMS.
− A WADA -approved Athlete Passport Management Unit (APMU) for the management of specific ABP processes.
− An Expert panel managed by the APMU qualified for the review of Passports .
2.2.2.
Specific Partner Responsibilities 2.2.2.1.
Anti-Doping Organization (ADO ) The ADO is responsible for: − Implementing and administrating an ABP program in accordance with these Guidelines, including compliance with applicable International Standards and Technical Documents .
− Contracting a WADA -approved APMU to manage the ABP program.
[Comment: T he list of WADA -approved APMU s is available at the following link: ABP Operating Guidelines – Version 9.0 – July 2023 Page 9/91 https://www.wada -ama.org/en/resources/athlete- biological- passport/list -of-athlete- passport -management -units -apmu ] − Ensuring that recommendations received from the APMU are followed by effective, targeted, timely and appropriate follow up actions, including further Testing and/or Sample Analytical Testing.
− Establishing and implementing a T est Distribution Plan for the ABP, in consultation with the APMU , and ensuring adaptive Testing throughout the year depending on changes in Passport status or other relevant intelligence.
− Sharing of relevant information with internal investigations personnel and other ADOs (when appropriate).
− Managing Passport custody and ensuring efficient Passport sharing with other ADO s having shared Testing jurisdiction over the Athlete .
− Providing APMU and Experts with supplementary information requested during Passport evaluation.
− When the ADO is the Passport Custodian, following up on Adverse Passport Findings ( APFs ) in accordance with Code and ISRM requirements.
− When necessary, i nforming the Athlete to seek independent medical advice in case the Passport indicates a “ likely medical condition” , as determined by the Experts .
2.2.2.2.
Athlete Passport Management Unit (APMU ) In compliance with the Technical Document related to Athlete Passport Management Unit Requirements and Procedures ( TD APMU, section 3.8 below), t he APMU is responsible for: − Timely management of Passports in ADAMS on behalf of the Passport Custodian.
− Performing Passport assessments to make timely Target Testing and Sample analysis recommendations to the Anti-Doping Organization (ADO) via the APMU Report in ADAMS when appropriate.
− Managing the review of atypical Passports according to Annex C of the International Standard for Results Management (ISRM) (Section 3.
7 below) , including, but not limited to, the following: o Issuing and updating APMU Report s in ADAMS, o In case of an Atypical Passport Finding ( ATPF) , or when a review is otherwise justified, assigning and liaising with the Expert panel as required, o Compiling all necessary information to establish an Athlete Biological Passport Documentation Package , and o Declaring Adverse Passport Findings (APFs ) to the Passport Custodian and WADA .
− Assessing and managing Passport Sample validity in ADAMS, in consultation with the Experts or Laboratories when necessary.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 10/91 − Collating and providing additional information requested by Experts (such as competition schedule or whereabouts information) to assist with Passport evaluation.
− Providing support to the Passport Custodian in defining priorities in order to optimize the efficiency of their ABP program.
These priorities may include, but are not limited to, cost efficiency, special analyses, Test Distribution Plans , and Target Testing.
2.2.2.3.
Laboratory The Laboratory is responsible for: − Urine analysis: perform urine analysis in compliance with the Technical Document on Measurement and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS) Markers of the Urinary Steroid Profile (TD EAAS, Section 3.
6 below) for the measurement and reporting of urinary steroid profiles.
− Blood (serum) Sample analysis: perform blood Sample analysis in compliance with the Laboratory Guidelines for the Analytical Requirements for the Endocrine Module of the Athlete Biologi cal Passport and the Laboratory Guidelines for the Quantification of Endogenous Steroids in Blood for the Athlete Biological Passport .
The Laboratory or ABP Laboratory is responsible for: − Blood ABP Sample analysis: perform blood ABP Sample analysis in compliance with the Technical Document on Analytical Requirements for the Hem atological Module of the Athlete Biological Passport (TD BAR, Section 3.
3 below).
− Issuing a Certificate of Analysis or Laboratory Documentation Package as applicable, in accordance with the Technical Document for the production of Laboratory Documentation Packages (TD LDOC) .
− Collating and providing additional information for interpretation of results and for complementary analysis.
2.2.2.4.
Experts Experts are responsible for: − Reviewing Passport data and results from the Adaptive Model in ADAMS provided by the APMU in order to assess the likelihood that the Passport is the result of normal physiological variation, the result of the Use of a Prohibited Subst ance or Prohibited Method, or the result of other potential causes.
− Recommending follow -up Testing, Sample analysis, and/or , when justified, recommending clinical testing that may be required to confirm their assessment.
− Reviewing any explanations given by the Athlete and providing an opinion on whether the Passport is “Normal”, “Suspicious”, “Likely doping” or “Likely medical condition” per Annex C of the ISRM .
− Working with the relevant APMU as required and providing support as necessary throughout the Results Management and hearing process.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 11/91 2.3.
ABP Management and Administration The daily management of an ABP program is carried out through the cooperation of the Passport Custodian and the APMU .
While the Passport Custodian oversees test distribution for the ABP, Passport management is carried out by the APMU on behalf of the Passport Custodian.
In the administrative sequence of the ABP, t he APMU provides a link between the Passport Custodian, the Laboratories , and the Expert panel.
Within each Passport in ADAMS, the APMU Report provides a record of these various interactions for efficient follow -up by the Passport Custodian, WADA and other ADOs with whom the Passport is shared though ADAMS.
2.3.1.
Defining, Testing and Target Athletes An ABP Testing Program must be managed in accordance with the ISTI , the ISRM , the Technical Document for Sport Specific Analysis (TD SSA) and applicable Technical Documents specific to the ABP (Part Three below).
Without limitation, the criteria listed in ISTI Article s 4.2 and 4.5 are factors that may be considered in determining the target population for the ABP in the context of an ADO’s overall Test Distribution Plan (TDP).
Targeted tests that follow the recommendations of the APMU should be privileged over Random Selection Testing to improve the effectiveness of the ABP.
Importantly, ADO s should have an internal procedure in place to ensure that rapid reactive follow up T esting can be carried out for atypical Passports when appropriately recommended by the APMU , regardless of the level of the Athlete .
ADOs should also ensure they can implement an adaptive Testing strategy during the year that can allocate tests to Athletes with Passports containing suspicious features.
As such, a small contingency of reactive tests dedicated to the ABP should be part of an ADOs Test Distribution Plan.
In general, the effectiveness of the ABP to detect doping is improved where both In - and Out-of Competition Testing are distributed strategically throughout the year.
As a single test represents a snapshot in time, i t is generally recognized that the ABP is more efficient when at least three (3) tests APMU Expert s Passport Custodian Laborato ries ABP Operating Guidelines – Version 9.0 – July 2023 Page 12/91 are planned per Athlete in a calendar year , across the athlete’s training, competition, and off -season periods , where additional reactive tests may be included should the Passport demonstrate abnormal features .
A Test Distribution Plan for the ABP should therefore seek to favor increased test numbers per Athlete , as opposed to T esting many Athletes 1-2 times a year.
This point is formalized for the Hematological Module, where the TDSSA requires ADOs to plan to test endurance Athletes annually, at a minimum, an average of three (3) times across all endurance Athletes in their Registered Testing Pool (RTP).
[Comment: The exceptional use of Advance Notice Testing can also be considered in specific situations (ex.
to establish baseline values in athletes at a competition). ]
When a blood ABP Sample is collected, the ADO must consider whether the collection of concomitant urine or blood Samples is warranted, under the circumstances, to perform additional analysis.
For the Hematological Module, it is recommended to collect urine Samples together with blood ABP Sample(s) in order to permit Analytical Testing for A AEs when required.
Similarly , when collecting blood (serum) S amples for the Steroidal Module, it is recommended to collect urine Samples in order to provide additional information based on steroid profile or the presence of potential confounding factors from the urine S ample in addition to the possibility to carry out GC/C/IRMS analysis.
[Comment: For the Hematological Module, it is recommended to use data from samples collected 5 days apart or more to optimize the statistical significance of the data.
This does not preclude Testing an Athlete less than five (5) days apart, notably and without limitation, when a potential risk of doping practices has been identified, or when recommended by the APMU .
The validity of the Samples and their inclusion in the Expert review is , in any event , not put in question by the collection frequency. ]
2.3.2.
Sample Collection and Transportation While urine S amples have no specific requirements for collection and transport beyond those outlined in the Guidelines for Sample Collection , blood (serum) and blood ABP Samples shall be collected and transported according to defined conditions to ensure reliable measurement of the relevent Markers .
Sample type Collection Transport Time after exercise Supplementary form Temperature logger Time Urine --- No No Should be performed as soon as possible.
Blood ABP >120 min (2 hours) Yes (ISTI Article I.2.9) Yes (ISTI Article I.2.7 ) Using the Blood Stability Score (BSS).