Athlete Biological Version 9.

0
July 2023

Passport Operating
Guidelines

World Anti-Doping Agency

Table of Contents

Content 3
Part 1: Introduction and Objectives 4
1.1. Introduction to the Athlete Biological Passport 4
1.2. Objectives 4
Part 2: Modules, Management and Administration 6
2.1. Modules 6
2.2. Resources, Partner Roles and Responsibilities 8
2.3. ABP Management and Administration 11
2.4. Passport Custody and Sharing 16
Part 3: Mandatory Protocols 19
3.1. Scope 19
3.2. Collection, Storage and Transport of Blood Athlete Biological Passport Samples
(ISTI Annex I) 20
3.3. Analytical Requirement for the Hematological Module of the Athlete Biological
Passport 25
3.4. Laboratory Guidelines – Analytical Requirements for the Endocrine Module of the
Athlete Biological Passport 31
3.5. Laboratory Guidelines - Quantification of Endogenous Steroids in Blood for the
Athlete Biological Passport 41
3.6. Measurement and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS)
Markers of the Urinary Steroid Profile 48
3.7. Results Management Requirements and Procedures for the Athlete Biological
Passport (ISRM Annex C) 58
3.8. Athlete Passport Management Unit Requirements and Procedures 66
Part 4: Collaboration Agreement Template 84

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Content
This document is divided into four parts.
Part One provides background and context for the creation of the Athlete Biological Passport (ABP),
introduces the Hematological, Steroidal, and Endocrine Modules of the Passport and explains the role
of the ABP Operating Guidelines in supporting Anti-Doping Organizations (ADOs).
Part Two describes the Modules and explains the principles for the implementation of the ABP by an
ADO.
Part Three contains Annexes of the International Standard for Results Management (ISRM), the
International Standard for Testing and Investigations (ISTI) in connection with Technical Documents
and Laboratory Guidelines that specify mandatory protocols to be followed by ADOs, Laboratories,
and Athlete Passport Management Units (APMUs) in order to run an ABP program.
Part Four includes a template agreement developed by WADA for the sharing of Passport information
between multiple ADOs (supported by ADAMS).

[For the purpose of these Guidelines, Code definitions are in Italics. International Standard definitions
are Underlined.]

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Part 1: Introduction and Objectives
1.1. Introduction to the Athlete Biological Passport
The term “athlete biological passport” was first proposed in the early 2000s by the scientific community
when monitoring of select hematological variables (Markers of blood doping) was identified as a
means to define an individual’s hematological profile. In conjunction with several stakeholders and
medical experts, the World Anti-Doping Agency (WADA) began to further develop, harmonize and
validate the utility of within-individual serial monitoring of biological parameters to identify
physiological patterns of doping. The result was a formal operating Guideline and mandatory
Standards formalizing the Athlete Biological Passport (ABP), first published in 2009, which concerned
exclusively the Hematological Module.
In 2014, the initial system was complemented with the Steroidal Module, which aims to establish
longitudinal profiles of an Athlete’s steroid variables in urine Samples. Additional steroid variables
measured in blood (serum) Samples were added in 2023 to complement the urine steroid profile.
The Endocrine Module was also added in 2023 to monitor Markers of human Growth Hormone (hGH).
The framework proposed in these Guidelines builds on existing anti-doping infrastructure to promote
harmonization amongst ABP Programs, to facilitate the exchange and mutual recognition of relevant
information between stakeholders involved in the ABP process and, consequently, to enhance
efficiencies in the operation of Anti-Doping Activities.
These Guidelines provide a harmonized process for the Hematological, Steroidal and Endocrine
Modules of the ABP, which follow similar administrative procedures and utilize WADA’s Anti-Doping
Administration and Management System (ADAMS).
As with all Guidelines, this document is subject to ongoing review to ensure it continues to reflect best
practice moving forward. WADA encourages feedback on this document and recommends
stakeholders to consult WADA’s website (http://www.wada-ama.org) for the latest version.

1.2. Objectives
The principal objectives of integrating the ABP into the larger framework of a robust anti-doping
program are the following:
a) The ABP can be used to flag Athletes and Samples requiring further attention through
intelligent, timely interpretation of Passport data, which can lead to an Anti-Doping Rule
Violation (ADRV) through establishment of the presence of a Prohibited Substance or its
Metabolite or Marker in an Athlete’s Sample according to World Anti-Doping Code (Code)
Article 2.1. The ABP provides valuable information that can be used to direct Target Testing,
Sample storage and further analysis of previously collected Samples more effectively. The

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 ABP can notably be used as a complement to Analytical Testing Procedures to further refine
and strengthen overall anti-doping strategies:
• For the Hematological Module, this could be, for example, by directing Testing
for Agents Affecting Erythropoiesis (AAEs) or homologous blood transfusion
(HBT).
• For the Steroidal Module, this could be, for example, the use of Gas
Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC/C/IRMS) to
detect endogenous steroids administered exogenously, or for the analysis of
steroid esters on atypical Samples targeted by using the ABP.
• 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 Methods 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 merged 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 Samples, 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 nationalities 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
programs by adding to aspects such as Athlete Education, whereabouts, traditional testing
strategies and Results Management thereby having the potential to improve deterrence of
athletes and their entourage from engaging in doping behaviour.

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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 module 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 AAEs 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#: Reticulocytes count
− RET%: Reticulocytes percentage
− WBC: White blood cells

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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 is 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 module aims to identify
hGH use and as well as use of hGH analogs, fragments and releasing factors categorized under
Section S2.2 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):

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 − GH-2000 Score
− IGF-I: Insulin-like Growth Factor-I
− P-III-NP: N-terminal Pro-peptide of Type III Collagen

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 Results
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 required 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: The list of WADA-approved APMUs is available at the following link:

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 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 Test 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 ADOs 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, informing 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), the 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 Reports 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.

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 − 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
Biological 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 Hematological 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 Substance 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.

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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, the 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.

Passport Custodian

Laboratories APMU Experts

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 Articles 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, ADOs should have an internal
procedure in place to ensure that rapid reactive follow up Testing 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, it is generally recognized that the ABP is more efficient when at least three (3) tests

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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 Testing 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 AAEs when required. Similarly, when collecting
blood (serum) Samples 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 Sample 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 Samples 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 Yes Using the Blood
Stability Score (BSS).
(ISTI Article I.2.9) (ISTI Article I.2.7)
(ISTI Article I.4)

Blood (serum) >60 min (1 hour) No Yes As soon as possible,

and up to 72h.*
(ISTI Article D.4.16)

*Blood (serum) Samples may be analyzed by different methods with varying requirements for collection to
analysis time. Best practice dictates that a Sample should arrive at the Laboratory as soon as possible. A
maximum of 72h of transportation time is generally recommended as it ensures the potential application of the
hGH Isoform Differential Immunoassay to Sample following analysis for the Endocrine Module. An additional

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24h is permitted in the case of analysis for the Endocrine Module or the hGH Biomarkers Test. Both cases
assume 24h of handling time for Samples in the Laboratory in an unfrozen state.

2.3.3. Sample Storage

As part of a comprehensive strategy for long term storage of Samples, ADOs are recommended to
consider Passport information as part of the criteria for long term storage in order to decide which
Samples to store and for how long.
The longitudinal nature of the ABP can uncover atypical features that may warrant further Analytical
Testing in the most recent Sample, but also in previous Samples. For example, an ATPF for low T/E
in a steroidal Passport may indicate that a GC/C/IRMS analysis should be performed not on the most
recent Sample, but on a previous Sample. Therefore, such a Sample storage strategy should consider
the general frequency of Sample collection in order to improve the chance of such Samples being
available for retroactive analysis.
Passport status can also be used to drive Sample storage decisions. For example, an ADO may wish
to store all Samples for which there is a “suspicious” APMU recommendation in ADAMS. Similarly,
an APMU may directly recommend that an ADO consider storing Samples for a given Athlete
displaying abnormal features in their Passport.
With regards to Sample type, given that blood (serum) Samples now have the possibility of retroactive
analysis for the Endocrine and Steroidal Modules, it is recommended to consider systematically
storing such blood Samples for a longer period than the minimum three months that is required by
Lanoratories (for example, 12 months).

2.3.4. Athlete Information

Given that additional information is required from Athletes beyond what is collected in traditional
Doping Control documentation pursuant to the ISTI, supplemental documentation may be required.
Such documentation may be collected as appropriate, both prior to and after Testing, for APMU
assessment and Expert review, as required.
For blood ABP Samples, in addition to the mandatory information set out in ISTI Article 7.4.5, which
must be recorded as a part of all Sample Collection Sessions, the information listed in ISTI I.2.9
(Section 3.2 below) shall be recorded in a specific ABP Supplementary Form or a related form to be
signed by the Athlete.
[Comment: See the available ABP Supplementary Form template: https://www.wada-
ama.org/en/resources/world-anti-doping-program/athlete-biological-passport-supplementary-report-
form]

2.3.5. Standardization through ADAMS

The ABP Program is administered through ADAMS, a secure online database management tool for
data entry, storage, sharing, and reporting, designed to assist stakeholders and WADA in their anti-

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doping operations. An essential element of the ABP, the Adaptive Model, is fully integrated into
ADAMS. Only programs that fully utilize ADAMS can be considered ABP Programs.
Standardization and harmonization of ABP programs is achieved through the use of ADAMS. This
ensures that all mandatory requirements are met and that the Athlete Passports are shared and stored
securely, all in accordance with the International Standard for the Protection of Privacy and Personal
Information (ISPPPI). Furthermore, ADAMS facilitates prompt exchange of information between
ADOs, APMUs, Laboratories and/or ABP Laboratory, Sample Collection Personnel, and WADA.

2.3.6. The APMU Report

The APMU Report is a central element in the administrative sequence of the ABP that shall be entered
and maintained by the APMU in ADAMS. The APMU Report provides an up-to-date overview of the
current status of an Athlete’s Passport together with recommendations, as appropriate, for efficient
follow-up by the Passport Custodian. The APMU Report serves to update the Passport Custodian,
WADA and other ADOs with whom the Passport is shared. In addition, it provides a record of events
associated with a Passport in ADAMS.
As detailed in the TD APMU (see section 3.8), the APMU Report may include, without limitation:
− Assessments of Sample validity by the APMU and/or Experts;
− Recommendations for complementary Analytical Testing (e.g., ESAs, HIF stabilizers,
confirmation of steroid profile, GC/C/IRMS, long-term steroid Metabolites, IGF-I, etc.) on
Samples collected;
− Recommendations for further Analytical Testing on Samples collected previously;
− Recommendations for storing of Samples for extended periods of time for Further Analysis;
− Target Testing recommendations based on available data and Experts’ recommendations;
and a summary of any recent Expert reviews.

2.3.7. Recommended Administrative Sequence

The following outlines the suggested sequence of interactions between the Athlete, Sample Collection
Personnel, ADOs, Laboratory(ies), ADAMS, APMUs, and Expert panels to establish, follow up and
review an individual Athlete’s Passport in an effective and efficient manner.
The recommended administrative sequence outlined below may be modified or adapted to fit with
existing anti-doping infrastructure, procedures and mechanisms as required. However these
Guidelines aim to ensure that ADOs establish a process that demonstrates transparency in the
planning, interpretation and Results Management aspects of an ABP program.

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2.3.8. ABP Administrative Sequence Graphic

The ADO identifies the Athlete of interest for Testing.

Athlete
Selection

The ADO identifies the ideal timing for Sample collection, in line with any
Timing
relevant recommendations from the APMU.2
of Test

The ADO issues a Sample collection request, which includes the type of Sample
to be collected (blood ABP, blood (serum), and/or urine).
Issuing
Request

The Sample Collection Authority accesses the pertinent whereabouts

information of the Athlete via ADAMS (for only the period defined by the issuing
Locating organization), and any other relevant Testing instructions.
Athlete

The Sample Collection Personnel locates the Athlete and collect the biological
Sample(s), following the appropriate protocol. An ABP Supplementary Doping
Sample
Control form is to be completed as outlined in Annex I of the ISTI (Section 3.2
Collection below) where Doping Control includes a blood ABP Sample.

For blood ABP Samples, the Sample Collection Personnel ensure transport to a
Laboratory or ABP Laboratory, in accordance with Annex I of the ISTI (Section
3.2 below). Urine Samples should be rapidly transported to a Laboratory, with
Transport minimal exposure to high temperature. For Samples collected for the Endocrine
of Sample
Module or for steroid analysis in blood Samples, the Samples must be
transported to a Laboratory able to perform the relevant Analytical Testing
Procedure, in accordance with the transport conditions outlined in (see 2.3.3
above).

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ABP Administrative Sequence Graphic, cont.
The Sample Collection Authority or the Sample Collection Personnel shall enter
the ABP Doping Control form into ADAMS without delay. This connects the
ADAMS
results of Sample analysis to the Athlete’s unique Passport and links the new
Entry Sample data with the Athlete’s historical data for review by the APMU and ADO.

The Laboratory or ABP Laboratory analyzes the Sample(s) following the

established protocol for blood ABP, blood (serum) and/or urine, as appropriate
Sample (Section 3.3-3.6), and reports the biological results in ADAMS without delay.
Analysis

Once the new biological data are entered in ADAMS, the Adaptive Model in
ADAMS automatically updates the Athlete’s Passport and any resulting
Passport notifications are sent.
Updated

The APMU updates the APMU Report in ADAMS including a review of the new or
APMU updated Passport with recommendations on intelligent Testing strategies.
Report

In the event of an ATPF or when a review is otherwise justified, the APMU shall
proceed with the mandatory steps outlined in Annex C of the ISRM (see Section
Review 3.7), which includes liaising with the Experts.
process

2.4. Passport Custody and Sharing

For any individual Athlete, only one Passport is to be established. Using ADAMS for the management
of Passport information, ADOs enhance efficiency and program effectiveness through exchange of
information and mutual recognition of program outcomes. Such coordination and reciprocal
agreement reduce unnecessary duplication in resource expenditure and foster enhanced confidence
among ADOs and Athletes alike.
All Doping Control biological results obtained for an Athlete are collated in their Passport regardless
of the Testing Authority. Only a complete Athlete’s Passport allows the correct determination of
Atypical Passport Findings in ADAMS. Passport administration and possible Results Management
can then follow in compliance with the Code with the assurance that the Passports are complete.
Within the framework provided by the ISPPPI and as required by the ISTI (Article 4.9.1), ADOs shall
coordinate their activities where multiple ADOs have Testing jurisdiction over a single Athlete and
multiple ADOs may wish to perform Passport Testing. In the interests of a “one Athlete – one

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Passport” principle, ADOs shall work cooperatively to see that Testing is coordinated appropriately
with all results collated in the Athlete’s Passport in ADAMS and that the Passport Custodian shares
the Passport with other ADOs having shared Testing jurisdiction over the Athlete.

2.4.1. Role of the Passport Custodian

Each individual Athlete has a Passport Custodian that ensures that all ADOs that have Testing
jurisdiction over the Athlete do not work in isolation. The Passport Custodian is responsible for sharing
Passport information with other ADOs to ensure proper coordination and best use of resource
expenditure. WADA has developed a template agreement for the sharing of Passport information
between multiple ADOs (supported by ADAMS), which is included herein in Part Four.
In addition to sharing Passport information with ADOs directly via ADAMS, the Passport Custodian is
also responsible for ensure the sharing of relevant Passport-related information with Major Event
Organizers (MEO) who are planning Testing around an upcoming competition. Prior to the event, the
Passport Custodian is responsible for providing relevant testing recommendations to the MEO
including Passport status and/or recent APMU recommendations in order assist MEOs to prioritize
their test distribution. During the event, the Passport Custodian should ensure that rapid
communication of APMU recommendations can be made during the competition in response to MEO
testing, which will allow the MEO to conduct any follow up testing or additional analysis that may be
required as a result of the MEOs testing.
The Passport Custodian is responsible for Results Management of Athlete Passports under their
custody. In the case of an ATPF, or when a review is otherwise justified, the APMU contracted by the
Passport Custodian is responsible for initiating the Passport review process on behalf of the Passport
Custodian. If an APF is declared, the Passport Custodian is responsible for Results Management of
the Passport in compliance with Annex C of the ISRM (Section 3.7 below), regardless of whether
another ADO was the Testing Authority of the test that triggered the ATPF.
As outlined in ISTI Article 10.4, where the Testing Authority is not the Passport Custodian, the Testing
Authority that initiated and directed the Sample collection maintains the responsibility for additional
Analytical Testing of the Sample, including the performance of further Confirmation Procedure(s)
upon requests generated automatically by the Adaptive Model of the ABP in ADAMS (e.g. GC/C/IRMS
triggered by elevated T/E) or as requested by the APMU (e.g. GC/C/IRMS requested due to abnormal
secondary Markers of the urinary “longitudinal steroid profile”; AAE tests due to suspicious
hematological Marker values) and Results Management of the Sample Analytical Testing results.

2.4.2. Attribution and Transfer of Passport Custody

In ADAMS, Passport custody is attributed to the Testing Authority that first tests the Athlete,
independently of whether it is a blood ABP test, a blood (serum) test, a urine test, or a combination
of these. This process ensures that the custody will most likely automatically be assigned to the
organization that has a real interest in the Athlete. When the Athlete is first tested by a Major Event
Organization (MEO), Passport custody is attributed to the IF. When a NADO first tests an Athlete with

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a different sport nationality, Passport custody is attributed to the IF. This can later be reassigned to
the NADO of the sport nationality of the Athlete if appropriate.
Passport custody can be transferred in ADAMS by the Passport Custodian to another ADO with
Testing jurisdiction over the Athlete. ADOs should have a procedure in place to monitor their pool of
Passports at regular intervals (ex. quarterly) using the reporting functionalities in ADAMS in order to
identify Passports potentially more suitable for management by another ADO. Reasons for
transferring Passport custody may include a change in Athlete level, more frequent Testing by another
ADO, or be based on a strategic agreement between ADOs with Testing jurisdiction over the Athlete.
The Passport Custodian should make requests in writing regarding any transfers of Passport custody
to the recipient ADO. If no agreement can be found on the Passport custody, WADA shall determine
which ADO is the Athlete’s Passport Custodian. WADA shall not rule on this without consulting the
ADOs involved.

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Part 3: Mandatory Protocols
3.1. Scope
ADOs implementing an ABP Program shall follow mandatory protocols documented in Annexes of
the International Standard for Results Management (ISRM) and International Standard for Testing
and Investigations (ISTI). Included herein for the ease of reference, these requirements have been
established to harmonize the results of monitored biological Markers within the ABP to ensure both
legal fortitude and scientific certainty. This standardization of procedure allows for the sharing and
mutual recognition of Passport data between the anti-doping programs of multiple ADOs. Only
programs that fully adhere to these protocols and fully utilize ADAMS can be considered ABP
Programs. These protocols are linked to Technical Documents and Laboratory Guidelines that a
Laboratory or ABP Laboratory shall follow for the analysis of Samples collected within the framework
of the ABP (included herein for the sake of completeness).
Section 3.2 sets out the minimum requirements for Sample collection and Sample transport that an
ADO shall fulfil to run the Hematological Module of the ABP program (Annex I of the ISTI). Sections
3.3-3.6 are Technical Documents and Laboratory Guidelines intended for Laboratory or ABP
Laboratory personnel that aim to harmonize the analysis of blood ABP, blood or urine Samples
collected for the measurement of the Markers of the Hematological, Endocrine and Steroidal Modules
of the ABP. Section 3.7 sets out the requirements and procedures that the Passport Custodian and
its APMU shall follow for Result Management for the ABP (Annex C of the ISRM). Finally, Section 3.8
outlines the requirements and procedures for WADA-approved APMUs.

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3.2. Collection, Storage and Transport of Blood
Athlete Biological Passport Samples (ISTI
Annex I)
I.1 Objective

To collect an Athlete’s blood Sample by venipuncture, intended for use in connection with
the measurement of individual Athlete blood variables within the framework of the
hematological module of the Athlete Biological Passport program, in a manner appropriate
for such use. The requirements of this Annex are additional requirements to those
contained in Annex D - Collection of Venous Blood Samples.

I.2 Requirements

I.2.1 Planning shall consider the Athlete’s whereabouts information to ensure Sample
collection does not occur within two (2) hours of the Athlete’s training, participation
in Competition or other similar physical activity. If the Athlete has trained or
competed less than two (2) hours before the time the Athlete has been notified of
their selection, the DCO or other designated Sample Collection Personnel shall
chaperone the Athlete until this two-hour period has elapsed.

I.2.2 If the Sample was collected within two (2) hours of training or Competition, the
nature, duration and intensity of the exertion shall be recorded by the DCO to
make this information available to the APMU.

I.2.3 Although a single blood Sample is sufficient within the framework of the
hematological module of the Athlete Biological Passport, it is recommended to
collect an additional (B) Sample for a possible subsequent analysis of Prohibited
Substances and Prohibited Methods in whole blood (e.g., detection of
homologous blood transfusion (HBT) and/or erythropoietin receptor agonists
(ERAs)).

I.2.4 For Out-of-Competition Testing, A and B urine Samples should be collected

together with the blood Athlete Biological Passport Sample(s) in order to permit
Analytical Testing for ERAs unless otherwise justified by a specific intelligent
Testing strategy.

[Comment to I.2.4: WADA’s Guidelines for Sample Collection reflect these

protocols and include practical information on the integration of Athlete Biological
Passport Testing into “traditional” Testing activities. A table has been included
within WADA’s Guidelines for Sample Collection that identifies which particular
timelines for delivery are appropriate when combining particular types of analysis
(e.g, blood Athlete Biological Passport and growth hormone (GH), blood Athlete
Biological Passport and HBT, etc.), and which types of Samples may be suited
for simultaneous transport.]

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 I.2.5 The Sample shall be refrigerated from its collection until its analysis with the
exception of when the Sample is analyzed immediately following collection. The
storage procedure is the DCO’s responsibility.

I.2.6 The storage and transport device shall be capable of maintaining blood Athlete
Biological Passport Samples at a cool temperature during storage. Whole blood
Samples shall not be allowed to freeze at any time. In choosing the storage and
transport device, the DCO shall take into account the time of storage, the number
of Samples to be stored in the device and the prevailing environmental conditions
(hot or cold temperatures). The storage device shall be one of the following:

a) Refrigerator;

b) Insulated cool box;

c) Isotherm bag; or

d) Any other device that possesses the capabilities mentioned above.

I.2.7 A temperature data logger shall be used to record the temperature from the
collection to the analysis of the Sample except when the Sample is analyzed
immediately following collection. The temperature data logger shall be able to:

a) Record the temperature in degrees Celsius at least once per minute;

b) Record time in GMT;

c) Report the temperature profile over time in text format with one line per
measurement following the format “YYYY-MM-DD HH:MM T”; and

d) Have a unique ID of at least six characters.

I.2.8 Following notification to the Athlete that they have been selected for Sample
collection and following the DCO/BCO’s explanation of the Athlete’s rights and
responsibilities in the Sample collection process, the DCO/BCO shall ask the
Athlete to remain still, in an upright, stationary seated position, with feet on the floor
for at least ten (10) minutes prior to providing a blood Sample. If the Athlete’s feet
cannot reach the floor and/or the Athlete’s impairment does not allow feet on the
floor, the Athlete shall remain in an upright, stationary seated position.

[Comment to I.2.8: The Athlete shall not stand up at any time during the ten (10)
minutes prior to Sample collection. To have the Athlete seated during ten (10)
minutes in a waiting room and then to call the Athlete into a blood collection room
is not acceptable.]

I.2.9 The DCO/BCO shall collect and record the following additional information on an
Athlete Biological Passport supplementary form, Athlete Biological Passport
specific Doping Control form or other related report form to be signed by the
Athlete and the DCO/BCO:

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 a) Has the Athlete been seated for at least ten (10) minutes with their feet on
the floor prior to blood collection, as per Annex I.2.8?

b) Was the Sample collected immediately following at least three (3)

consecutive days of an intensive endurance Competition, such as a stage
race in cycling?

c) Has the Athlete had a training session or Competition in the two (2) hours
prior to the blood collection?

d) Did the Athlete train, compete or reside at an altitude greater than 1,500
meters within the prior two (2) weeks? If so, or if in doubt, the name and
location of the place where the Athlete had been, and the dates and the
duration of their stay shall be recorded.

The estimated altitude shall be entered, if known.

e) Did the Athlete use any form of altitude simulation such as a hypoxic tent,
mask, etc. during the prior two (2) weeks? If so, as much information as
possible on the type of device and the manner in which it was used (e.g.,
frequency, duration, intensity) should be recorded.

f) Did the Athlete receive any blood transfusion(s) during the prior three (3)
months? Was there any blood loss due to accident, pathology or donation in
the prior three (3) months? If so, the estimated volume should be recorded.

g) Has the Athlete been exposed to any extreme environmental conditions

during the last two (2) hours prior to blood collection, including any sessions
in any artificial heat environment, such as a sauna? If so, the details should
be recorded.

I.2.10 The DCO/BCO shall start the temperature data logger and place it in the storage
device. It is important to start recording the temperature before Sample
collection.

I.2.11 The storage device shall be located in the Doping Control Station and shall be kept
secure.

I.2.12 The DCO/BCO instructs the Athlete to select the Sample Collection Equipment in
accordance with Annex D.4.6 and continue the Sample Collection Session in
accordance with Annex D.4.7.

I.3 The Sample Collection Procedure

I.3.1 The Sample collection procedure for the collection of blood for the purposes of the
Athlete Biological Passport is consistent with the procedure set out in Annex D.4,
including the ten (10) minute (or more) seated period.

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 I.3.2 The Athlete and the DCO/BCO sign the Doping Control and Athlete Biological
Passport
supplementary form(s), when applicable.

I.3.3 The blood Sample is sealed and deposited in the storage device containing the
temperature data logger.

I.4 Transportation Requirements

I.4.1 Blood Samples shall be transported in a device that maintains the integrity of
Samples
over time, due to changes in external temperature.

I.4.2 The transport procedure is the DCO’s responsibility. The transport device shall
be transported by secure means using a Sample Collection Authority
authorized transport method.

I.4.3 The integrity of the Markers used in the hematological module of the Athlete
Biological Passport is guaranteed when the Blood Stability Score (BSS)
remains below eighty-five (85), where the BSS is computed as:

BSS = 3 * T + CAT
with CAT being the Collection to Analysis Time (in hours), and T the average
Temperature (in degrees Celsius) measured by the data logger between
Sample collection and analysis.

I.4.4 Within the framework of the BSS, the following table can be used by the
DCO/BCO to estimate the maximal transport time to a Laboratory or ABP
Laboratory, called the Collection to Reception Time (CRT), for a given average
temperature (T), e.g., if shipped at 4°C, the maximal CRT is 60 h.:

T [°C] CRT [h]

15 27
12 36
10 42
9 45
8 48
7 51
6 54
5 57
4 60

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 I.4.5 The DCO/BCO shall as soon as possible transport the Sample to a
Laboratory or ABP
Laboratory.

I.4.6 The Testing Authority or Sample Collection Authority shall report without
delay into
ADAMS:

a) The Doping Control form, as per Article 4.9.1 b);

b) The Athlete Biological Passport supplementary form, and/or the additional

information specific to the Athlete Biological Passport collected on a
related report form;

c) In the Chain of Custody, the temperature data logger ID

(without any time reference) and the time zone of the Testing
location in GMT.

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3.3. Analytical Requirement for the Hematological
Module of the Athlete Biological Passport
WADA Technical Document – TD2021BAR
Document Number: TD2021BAR Version Number: 2.0
Written by: WADA Science
Approved by: WADA Executive Committee
Reviewed by: WADA Laboratory Expert Group
Date: 20 May 2021 Effective Date: 01 June 2021

1.0 Introduction
The purpose of this Technical Document (TD) is to harmonize the analysis of ABP blood Samples
collected, both In-Competition and Out-of-Competition, for the measurement and reporting of
individual Athlete blood Markers within the framework of the hematological module of the Athlete
Biological Passport (ABP).
The International Standard for Laboratories (ISL) [1] is applicable to the analysis of ABP blood Samples
carried out in connection with the measurement of individual Athlete blood Markers within the
framework of the ABP. This TD describes certain specificities of blood analysis related to the ABP.
In order to standardize analytical results in the ABP, ABP blood Samples shall only be analyzed with
analyzers of comparable technical characteristics in the dedicated network of laboratories (i.e. WADA-
accredited laboratories or ABP Laboratories). The Analytical Method for measuring ABP blood
variables shall be included within the Laboratory or ABP Laboratory’s Scope of ISO/IEC (17025 or
15189) Accreditation, and the Laboratory or ABP Laboratory shall satisfactorily participate in the
relevant WADA External Quality Assessment Scheme (EQAS), as determined by WADA, prior to
applying the Analytical Method to ABP blood Samples.
Sample handling shall be conducted in compliance with the TD on Laboratory Internal Chain of
Custody (TD LCOC) [2].
If not reasonably possible for ABP blood Samples to be analyzed in a Laboratory or ABP Laboratory
for technical and/or geographical reasons, ABP blood Samples can be analyzed at a satellite facility
of a Laboratory or using mobile units operated by a Laboratory under their applicable ISO/IEC
accreditation (17025 or 15189). Satellite facilities and mobile units shall also be ISO/IEC (17025 or
15189) accredited and participate in the WADA EQAS for blood Markers for the ABP prior to analysis
of ABP blood Samples.

2.0 ABP blood Sample Reception and Timing of Analysis

Upon reception at the Laboratory or ABP Laboratory, the ABP blood Sample shall be analyzed as
soon as possible and no later than twelve (12) hours after reception unless the Sample Collection
Authority (SCA) provides specific information regarding the Sample collection and transportation

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conditions (for example, the SCA provides a projected time window for analysis during which the
projected Blood Stability Score (BSS) should remain acceptable) that would allow the Laboratory or
ABP Laboratory to analyze the Sample beyond twelve (12) hours after reception without
compromising the ABP blood Sample validity.
In cases when the Laboratory or ABP Laboratory is unable to analyze the ABP blood Sample
immediately after reception, the Laboratory or ABP Laboratory is responsible for maintaining the ABP
blood Sample(s) at a cool temperature (approximately 4°C) between reception and the start of the
analysis. The temperature data logger shall accompany the ABP blood Sample(s) until
homogenization.
The ABP blood Sample shall not be aliquoted before the ABP analysis is satisfactorily conducted.
Only after the analysis for the ABP has been satisfactorily completed may the Laboratory or ABP
Laboratory aliquot the ABP blood Sample for the performance of other Analytical Testing Procedures
(e.g. test for homologous blood transfusion, EPO and agents affecting erythropoiesis).
If there is a Laboratory or ABP Laboratory deviation from the aforementioned procedure, the
Laboratory or ABP Laboratory shall proceed with the analysis and report the results into ADAMS with
a detailed description of the deviation. If the ABP blood Sample cannot be analyzed, the Laboratory
or ABP Laboratory shall report the Sample as “Not Analyzed” and provide a description of why it could
not be analyzed in ADAMS.

3.0 Instrument Check

The Laboratory or ABP Laboratory shall maintain an instrument maintenance schedule to ensure
proper performance; particularly if an analysis has not been recently conducted and the instrument
remains idle for an extended period of time.
The analyst shall ensure that all reagents are within their expiration dates and comply with the reagent
manufacturer’s recommendations before performing an analysis. Operational parameters of the
instrument (background level, temperature of the incubation chambers, pressure, etc.) shall be
verified as compliant with manufacturer’s specifications.
In each analysis session:
• All internal quality controls (QC levels 1, 2 and 3) shall be analyzed twice, following the
specifications provided by the manufacturer, prior to the analysis of Samples.
• If more than 30 Samples are analyzed, at least one internal QC from the manufacturer (either
level 1, 2 or 3) shall be analyzed in the middle of the analytical session, and every 30 - 50
Samples for larger batches.
• At the end of each analysis session and after all blood Sample analyses are completed, one
internal QC (either level 1, 2 or 3) shall be analyzed once again to demonstrate the continuous
stability of the instrument and the quality of the analyses done.
All results relevant to the ABP shall be in agreement with the reference value ranges of the
manufacturer. These internal QCs shall be furnished exclusively by the instrument manufacturer and
handled in strict accordance with the manufacturer specifications (e.g. expiration dates, storage

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conditions). The analysis of internal QCs shall be monitored via QC-charts with appropriate control
limits.
At least once a month, following the satisfactory analysis of all internal QCs (levels 1, 2 and 3) as
described above, one fresh blood sample shall be homogenized for a minimum period of fifteen (15)
minutes on an appropriate mixer (e.g. roller mixer). The fresh blood sample shall be analyzed at least
seven (7) consecutive times under Repeatability conditions. The Repeatability of the determinations,
expressed as coefficients of variation (CV %), shall be below 1.5% for Haemoglobin (HGB) and
Haematocrit (HCT), and below 15% for Reticulocyte percentage (RET%).
[Comment: Samples from Athletes shall not be used as a fresh blood sample to conduct the Repeatability
analysis.]

4.0 External Quality Assessment Scheme (EQAS)

The Laboratories or ABP Laboratories shall participate in and meet the requirements of WADA’s
EQAS for blood Markers for the ABP. WADA’s EQAS program is the only EQAS relevant to the
Laboratory’s or ABP Laboratory’s compliance with the requirements for the analysis of blood Markers
within the framework of the hematological module of the ABP (in case of discrepancy with other blood
EQAS programs).

All internal QCs (levels 1, 2 and 3) shall be analyzed twice following the specifications provided by
the manufacturer prior to the analysis of EQAS samples. All results relevant to the ABP shall be in
agreement with the reference value ranges of the manufacturer. The EQAS sample shall be
homogenized for a minimum period of fifteen (15) minutes using an appropriate mixer (e.g. roller
mixer) prior to analysis. The external QCs shall be analyzed multiple times consecutively (based on
the EQAS rules), and the mean results of the following blood variables (full blood count) shall be
returned:
Red Blood Cell (Erythrocyte) Count RBC
Mean Corpuscular Volume MCV
Haematocrit HCT
Haemoglobin HGB
Mean Corpuscular Haemoglobin MCH
Mean Corpuscular Haemoglobin Concentration MCHC
White Blood Cell (Leukocyte) Count WBC
Platelet (Thrombocyte) Count PLT
Reticulocytes Percentage RET%

Laboratories or ABP Laboratories may also participate in ring tests with other laboratories (hospitals,
clinics, etc.) using the same technology and the same procedure.

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5.0 Analysis of ABP Blood Samples

5.1 Temperature Data Logger

The temperature data logger shall be stopped before ABP blood Sample homogenization, upon
removal of the ABP blood Sample(s) from the cooling device or refrigerator. The ABP blood Sample
shall be homogenized prior to analysis and for a minimum period of fifteen (15) minutes using an
appropriate mixer (e.g. roller mixer).
In cases when the temperature data logger accompanies multiple ABP blood Samples, and these
ABP blood Samples are analyzed in the same batch by the Laboratory or ABP Laboratory, the
temperature data logger shall be stopped before the homogenization of the first ABP blood Sample.
The Laboratory shall proceed with the analysis of all ABP blood Samples associated with the same
temperature data logger without delay.

5.2 ABP Blood Sample Analysis

The ABP blood Sample shall be analyzed twice. The Laboratory’s or ABP Laboratory’s procedure
should minimize the delay between the two analyses. Absolute differences between the two (2)
analyses shall be equal or less than (≤) each of the following criteria in order to accept the results:
• 0.1 g/dL for HGB;
• 0.15% for RET% if either the first or second measurement is lower or equal to 1.00%;
otherwise 0.25% absolute difference.
The data from the second injection is used to confirm the first injection data. Therefore, if the absolute
differences between the results of the analyses are within the criteria above, then only the first
injection data is reported into ADAMS.
If the absolute differences between the results of the two analyses are greater than (>) those defined
above, then the ABP blood Sample shall be analyzed twice again in accordance with Article 5.2. In
cases of repeated analysis, the ABP blood Sample shall be mixed prior to re-analysis using the
automated mixing feature of the blood analyzer or by appropriate manual inversion. This reanalysis
procedure shall be repeated until the absolute differences between the results of the two (2) most
recent analyses are within the criteria specified above.
The requirements for an Initial Testing Procedure (ITP), an “A” Sample Confirmation Procedure (CP)
and a “B” Sample CP, as defined in the ISL [1], shall not be applicable to ABP blood Samples analyzed
for the purposes of the ABP.

6.0 Reporting
6.1 Temperature Report
The Laboratory or ABP Laboratory shall promptly submit into ADAMS the raw temperature profile
report recorded by the temperature data logger. The filename shall consist in the concatenation of the
data logger ID with the date of Sample reception by the Laboratory or ABP Laboratory (“YYYY-MM-
DD” in local time) separated by an underscore. For example, for a data logger ID “KG34V10” and a

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date of Sample reception “2015-03-25”, the Laboratory or ABP Laboratory shall report the
temperature profile under the filename “KG34V10_2015-03-25.txt”. The Laboratory or ABP
Laboratory shall report the temperature profile into ADAMS before the test results of the Sample,
when temperature data can be retrieved from the logger.
[Comment: Where the Sample meets the requirements of the ISTI Annex I, Article I.2.7, and is analyzed
at the Sample collection site without delay, a temperature data logger is not necessary and the Laboratory
shall proceed to reporting the test results of the Sample.
In cases that the Laboratory is unable to upload a suitable temperature profile report from the temperature
data logger into ADAMS, the Laboratory shall proceed to upload the test results of the relevant
Sample(s).]

6.2 Reporting ABP Blood Sample Test Results

The Laboratory or ABP Laboratory should report the ABP blood Sample test results as soon as
possible and within three (3) days after Sample reception. The following shall be reported into
ADAMS:
• Status (“Submitted” or “Not Analyzed”);
• ABP blood Sample code;
• Type of test (Out-of-Competition / In-Competition);
• Sport and discipline;
• Date and time of receipt of the ABP blood Sample;
• Date and time of analysis of the ABP blood Sample;
• The name of the Testing Authority;
• The name of the Sample Collection Authority;
• Type of Sample (blood Passport);
• Type of analyzer;
• Test results (other variables may be included for quality purposes):

Blood Variable Unit(s)

Haemoglobin HGB g/dL
Hematocrit HCT %
Immature Reticulocyte Fraction IRF %
Mean Corpuscular Haemoglobin MCH pg
Mean Corpuscular Haemoglobin Concentration MCHC g/dL
Mean Corpuscular Volume MCV fL
OFF-Score - -
Platelets PLT 103/µL
Red Blood Cell Distribution Width RDW-SD fL
Red Blood Cells RBC 106/µL
Reticulocytes – in absolute number RET 106/µL
Reticulocytes Percentage RET% %
White Blood Cells WBC 103/µL

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 • Include a comment describing any relevant deviation as part of the ABP blood Sample’s
ADAMS record.

7.0 References
[1] The World Anti-Doping Code International Standard for Laboratories (ISL).
[2] WADA Technical Document TD LCOC: Laboratory Internal Chain of Custody.
[Comment: Current versions of WADA ISL and Technical Documents may be found at
https://www.wada-ama.org/en/what-we-do/science-medical/laboratories ]

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3.4. Laboratory Guidelines – Analytical
Requirements for the Endocrine Module of the
Athlete Biological Passport

1.0 Objective
These Laboratory Guidelines have been developed to ensure a harmonized application of Analytical
Testing Procedures for the measurement of Markers of human Growth Hormone (hGH) as part of the
Endocrine Module of the Athlete Biological Passport (ABP). The document provides guidance on the
pre-analytical details, Sample preparation procedure, the performance of the analyses and the
reporting of the test results.

2.0 Scope
These Laboratory Guidelines contain requirements for the implementation of the Analytical Testing
Procedures for the quantification of hGH Markers as part of the Endocrine Module of the ABP, which
allows the detection of hGH doping and may also have utility in detecting GH secretagogues and IGF-
I abuse in sport 1,2. These Laboratory Guidelines follow the rules established in the WADA
International Standard for Laboratories (ISL) 3 and relevant Technical Documents (TDs) regarding the
Analytical Testing of blood Samples.

3.0 Introduction to the Analytical Testing Procedures

The Analytical Testing Procedures for the Endocrine Module involve the measurement of two (2)
Markers of hGH biological activity, namely Insulin-like Growth Factor-I (IGF-I) and N-terminal Pro-
peptide of Type III Collagen (P-III-NP), which are naturally present in blood and whose concentrations
are increased following hGH administration 4–11. The measured concentrations of these two (2)
Markers are then combined in a discriminant function formulae to calculate a GH-2000 score, which
is gender-specific and includes an adjustment for age to reflect the age-related decline in hGH and
Marker concentrations 4.
In order to generate individual Athlete longitudinal data that are comparable between Laboratories, a
specific IGF-I / P-III-NP assay pairing is applied for the measurement of concentrations of IGF-I and
P-III-NP in blood (serum) for the purposes of the ABP. The assays used for the Endocrine Module of
the ABP are limited to:
• Intact IGF-I quantification by top-down Liquid Chromatography-(tandem) Mass Spectrometry
(LC-MSn; n ≥ 1) 12, as detailed in Table 2 below.
• P-III-NP quantification using Siemens ADVIA Centaur P-III-NP chemiluminescence
immunoassay (Siemens Healthcare Laboratory Diagnostics, Camberley, UK). The Siemens
ADVIA Centaur P-III-NP assay is an automated, two-site sandwich, chemiluminescent

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 immunoassay 13. The assay uses two (2) monoclonal mouse antibodies: the first antibody is an
acridinium ester-labeled anti-P-III-NP antibody. The second antibody is a biotin-labeled
anti-P-III-NP antibody. The solid phase contains streptavidin-coated paramagnetic particles and
during the reaction, the light emitted by the acridinium label is directly proportional to the
concentration of P-III-NP in the sample. The Siemens P-III-NP assay is calibrated by the
manufacturer using a standard derived from bovine P-III-NP.
For the purposes of the ABP, an initial quantification of the “A” Sample is performed. When requested,
a confirmatory quantification of the “A” Sample may additionally be performed using the same assay
pairing (see, Article 6.2) to confirm the concentrations and to perform identification of IGF-I (as per
TD IDCR14).
The concentrations of IGF-I and P-III-NP reported by the Laboratories, as well as the GH-2000 score
automatically calculated in ADAMS, are integrated in the Endocrine Module of ADAMS using a similar
Bayesian approach to that applied in the Steroidal and Hematological Modules of the ABP 15.

4.0 Assay Pre-Analytical Procedure

− The Laboratory should (usually) receive refrigerated (not frozen i) “A” and “B” blood
Samples, which have been collected in blood tubes containing an inert polymeric serum
separator gel and a clotting activation factor (for example: BD Vacutainer® SSTTM-II Plus
tubes, EU ref 367955; BD Vacutainer® SSTTM-II Plus Advance tubes, EU ref 367954; BD
Vacutainer® SSTTM tubes, US ref 367986) in accordance with the International Standard
for Testing and Investigation (ISTI) 16;
[Comment: Previous studies have demonstrated that IGF-I and P-III-NP concentrations remain
stable if the Sample is maintained at a refrigerated temperature for up to 5 days 17.]
− Alternatively, if the clotting and centrifugation of the Sample is performed prior to reception
at the Laboratory (for example, at the site of Sample collection), Samples may be received
at the Laboratory as frozen/refrigerated blood Samples either in the same Sample
collection tubes or as separated serum in new tubes;
− The Laboratory shall check the status of the Sample(s) (e.g., evidence of hemolysis) and
the integrity of the collection tubes (e.g., evidence of breakage of the separating gel). The
Laboratory shall note any unusual condition of the Sample and record such condition(s) in
the Test Report in ADAMS;
− Any Samples delivered to the Laboratory in tubes containing an anti-coagulant (for
example, ABP blood Samples collected in EDTA tubes), or as separated plasma, shall not
be analyzed for Markers of the Endocrine Module;

i unless the blood matrix components have been separated before shipment to the Laboratory.

ABP Operating Guidelines – Version 9.0 – July 2023 Page 32/91

 − The Laboratory shall notify and seek advice from the Testing Authority regarding rejection
or Analytical Testing of Samples for which irregularities are noted (see ISL 3).

4.1 Samples received as non-separated blood in tubes containing an inert polymeric serum
separator gel and a clotting activation factor:
Reception Both Samples “A” and “B” shall be centrifuged for 10-15 min at 1300-1500 g
as soon as possible after reception at the Laboratory.
The “A” Sample shall be used for the initial and confirmatory (if needed)
quantifications (see below).
The “B” Sample shall be step-frozen and stored until use, if needed (see
below).
Aliquoting and Two (2) Aliquots of the “A” Sample serum shall be taken for initial
analysis quantification.
The remaining “A” serum fraction may be kept in the Sample collection tube
or aliquoted into new vials with label(s) ensuring that Laboratory Internal
Chain of Custody is maintained.
For initial quantification:
• the Aliquots may be analyzed immediately after aliquoting; or
• the Aliquots shall be stored at approximately 4 °C if analyzed within 24h
(within a maximum of five (5) days from Sample collection); or
• the Aliquots shall be frozen (-20°C) if the analysis will be conducted
more than 24h after aliquoting.
For the confirmatory quantification, two (2) new Aliquots of the “A” Sample
shall be analyzed immediately after aliquoting.
[Comment: When analyses specific to the ABP are requested for blood (serum) Samples (i.e.,
Markers of the Endocrine Module or blood steroid Markers as part of the Steroidal Module),
only the “A” Sample should be considered for the initial and the confirmatory quantifications of
the Markers. In cases where the “A” Sample is not suitable for the performance of ABP Markers
quantification (e.g., there is insufficient Sample volume; the Sample container has not been
properly sealed or has been broken; the Sample’s integrity has been compromised in any way;
the “A” Sample is missing), a splitting procedure of the “B” Sample could be performed, as
detailed in the ISL3.]
Storage Storage for up to three (3) months  at approximately -20 °C.
[The same storage Storage for more than three (3) months  freeze at approximately -20 °C
conditions apply for
and transfer to approximately -70 to -80 °C.
Samples received in
conditions described [Comment: If the separated serum fraction is kept in the Sample collection tube, it shall be step-
in section 4.2] frozen for storage according to the tube manufacturer’s instructions until analysis.
If the Laboratory transfers the Aliquot into new vials for frozen storage, the vials should ensure
proper sealing for optimal storage (cryovials with an “O-ring”).
Thawing of Sample(s) for analysis should also be done stepwise. Samples shall not be thawed
under hot water or any other similar process that risks raising the temperature of the Sample
above room temperature. Thawing overnight at 4°C is recommended.]

4.2 Samples received as frozen/refrigerated centrifuged blood/serum Samples:

Reception If Samples are received frozen, they should remain frozen until analysis as
described in this Article 4.2.
If Samples are received refrigerated, they should be processed as soon as
possible as per Article 4.1.

ABP Operating Guidelines – Version 9.0 – July 2023 Page 33/91

 Aliquoting and Once the Sample “A” is thawed, two (2) Aliquots shall be taken for initial
analysis quantification. These Aliquots may be stored at approximately 4 °C for a
maximum of 24h before analysis.
The remaining “A” serum fraction may be kept in the Sample collection tube
or aliquoted into new vial(s) with label(s) ensuring Laboratory Internal Chain
of Custody is maintained.
For the confirmatory quantification, two (2) new Aliquots of the “A” Sample
shall be analyzed immediately after aliquoting.

5.0 Analytical Testing Procedure Requirements

5.1 Analytical Testing Procedure Validation Requirements
Prior to the implementation of the Analytical Testing Procedures for the quantification of
IGF-I and P-III-NP in routine Doping Control analysis, the Laboratory shall fulfil the
following requisites:
− Validate the Analytical Testing Procedures, including the determination of the
assays’ Limit of Quantification (LOQ), Repeatability (sr), Intermediate Precision (sw),
Bias and Measurement Uncertainty (uc);
− The Analytical Testing Procedures shall meet the acceptance values for the
parameters of IGF-I and P-III-NP assay performance, as specified in Table 1 and
Table 2 (as applicable).

Table 1: Acceptance Criteria for Parameters of Assay Performance for the Endocrine Module

Validation Parameters IGF-I P-III-NP

Maximum LOQ ≤ 50 ng/mL ≤ 1 ng/mL

Maximum Relative Combined

Standard Measurement Uncertainty ≤ 20% ≤ 15%
(uc_Max, %)

5.2 Analytical Testing Procedure Accreditation Requirements

− Demonstrate readiness for assay implementation through method validation data
and successful participation in at least one WADA-approved educational External
Quality Assessment Scheme (EQAS) round or inter-Laboratory collaborative study.
In cases of identified deficiencies, proper corrective action(s) shall be documented
and implemented;
− Obtain ISO/IEC 17025 accreditation for the Analytical Testing Procedures for the
quantification of hGH Markers in blood as part of the Endocrine Module from an
Accreditation Body that is a full member of the International Laboratory Accreditation
Cooperation (ILAC) and a signatory to the ILAC Mutual Recognition Agreement
(ILAC MRA).

ABP Operating Guidelines – Version 9.0 – July 2023 Page 34/91

 5.3 Quality Controls (QCs) and Reagents
− QC samples: Laboratories shall implement well-characterized and stable internal QC
sample(s), which are not subject to assay lot variations, for the performance of the
tests under different assay conditions (different assay lots, different analysts, etc.).
Following preparation/reception by the Laboratory, all QC material should be
aliquoted and stored frozen (preferably at – 80°C for long-term storage) until use.
These QC samples should include:
o QClow: Serum obtained from healthy individual(s), which is demonstrated to
contain concentrations of IGF-I not greater than (≤) 200 ng/mL and P-III-NP not
greater than (≤) 5 ng/mL;
o QChigh: Serum obtained from hGH administration studies or another appropriate
source that has been demonstrated to contain concentrations of IGF-I greater
than (≥) 500 ng/mL and P-III-NP greater than (≥) 10 ng/mL.
[Comment: Four (4) separate QC samples may also be used, as long as they contain IGF-I
and P-III-NP at the necessary concentrations (e.g., QCIGF-I_low, QCIGF-I_high, QCPIIINP_low and
QCPIIINP_high).]
− Reagents: With every new batch of reagents (new lot number), the following
evaluation steps should be implemented before including the new batch into routine
operations for P-III-NP quantification:
o Each of the QC samples shall be determined at least three (3) times whenever
a new batch of reagents is obtained. The number of replicates per
determination shall be conducted as stipulated by the assay manufacturers.
The QCs may be measured in a single assay or over a range of assays. If, for
any QC, the difference between the mean concentration for the new batch and
that for the preceding batch is more than 20%, the new batch shall not be
implemented into routine operations and an investigation of the new batch shall
be conducted.
o In order to detect small but systematic changes over time, it is recommended
that the performance of a new batch of reagents is controlled, for example,
through a cumulative sum (CUSUM) chart/table, which is established for each
QC based on the difference between the mean(s) of the new batch and the
initial value(s). When using the CUSUM, results should be assessed using
customary procedures as detailed at
http://itl.nist.gov/div898/handbook/pmc/section3/pmc323.htm

6.0 Analytical Testing Procedure and Reporting of Test Results

6.1 Initial Quantification of the Markers
− Two (2) Aliquots taken from the original “A” Sample shall be analyzed once (x1) to
quantify intact IGF-I and P-III-NP;

ABP Operating Guidelines – Version 9.0 – July 2023 Page 35/91

 − QC Sample(s), at low- and high-levels of the Markers (see Article 5.3), shall be
included in each initial quantification analytical batch;
− The coefficient of variation (CV%) between the duplicate determinations of the IGF-
I and P-III-NP concentrations shall not be higher (≤) than the associated uc_Max (see
Table 1). If the CV% between duplicate determinations of only one Marker (IGF-I or
P-III-NP) exceeds the respective uc_Max, the analysis of only that Marker shall be
repeated;
− The mean Marker concentration from the duplicate measurement of IGF-I and P-III-
NP shall be reported in ADAMS in nanograms per milliliter (ng/mL);
[Comment: for the purposes of the Endocrine Module of the ABP, the GH-2000 score does
not need to be calculated or reported by the Laboratory since it will be automatically
calculated in ADAMS 15].

− If the measured Marker concentration is below the LOQ of the assay, the Laboratory
shall report a value of “-1” for its concentration in ADAMS and the Laboratory shall
make a comment in the Test Report on why the Marker could not be quantified (e.g.,
the measurement of the Marker is not possible due to unusual matrix interferences);
− An observation of hemolysis of the Sample should be recorded in the comments
section of the Laboratory Test Report in ADAMS.
6.2 Confirmatory Quantification of the Markers
If requested by the Testing Authority (TA), Results Management Authority (RMA) or WADA,
the Laboratory shall proceed with the confirmatory quantification of the Markers of the
Endocrine Module.
[Comment: An APMU or Passport Custodian (PC), where the PC is not the TA, may request a
confirmatory quantification on behalf of the TA or RMA. In such cases, the APMU or PC shall copy
the relevant TA or RMA, as applicable, on all written requests to the Laboratory for confirmatory
quantifications.]

When a confirmatory quantification analysis is requested:

− Two (2) new Aliquots taken from the original “A” Sample shall be analyzed once (x1)
to:
o quantify intact IGF-I and P-III-NP; and
o identify IGF-I (as per the TD IDCR 14);
− At least one QC Sample (see Article 5.3), depending on initial quantification results,
shall be included in each confirmatory quantification analytical batch;
− The CV (%) between the duplicate determinations of the IGF-I or P-III-NP
concentrations shall not be higher (≤) than the associated uc_Max (see Table 1). If the
CV% between duplicate determinations of only one Marker (IGF-I or P-III-NP)
exceeds the respective uc_Max, the analysis of only that Marker shall be repeated;

ABP Operating Guidelines – Version 9.0 – July 2023 Page 36/91

 − The mean Marker concentration from the duplicate measurement of IGF-I and P-III-
NP shall be reported in ADAMS in nanograms per milliliters (ng/mL);
− If the measured Marker concentration is below the LOQ of the assay, the Laboratory
shall report a value of “-1” for its concentration in ADAMS and the Laboratory shall
make a comment in the Test Report on why the Marker could not be quantified (e.g.,
the measurement of the Marker is not possible due to unusual matrix interferences);
− An observation of hemolysis of the Sample should be recorded in the comments
section of the Laboratory Test Report in ADAMS.

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Table 2. Analytical Testing Procedure Validation and Performance Requirements for the initial and
confirmatory quantification of IGF-I in blood (serum) Samples by top-down LC-MSn for the Endocrine
Module of the ABP.
Top-down (intact IGF-I) Liquid Chromatography combined with (Tandem)
Method and Instrumentation Mass Spectrometry based on triple quadrupole or HRMS (LC-MSn; n ≥
1).
Shall cover the ranges of IGF-I concentrations normally found in males
Range of the Method and females and demonstrate linearity between 50–1000 ng/mL, at
least.

Limit of Quantification (LOQ) The LOQ shall not be greater than (≤) 50 ng/mL.

Maximum Relative Combined

Standard Measurement The estimated uc (%) shall not be greater than (≤) 20%.
Uncertainty uc (%)
IGF-I quantification shall be conducted in duplicate (using two Aliquots of
Sample the “A” Sample) using a volume not greater than (≤) 50 μL of serum per
replicate.

Internal Standard Stable isotope-labeled IGF-I (e.g., NIST ii or ProSpec iii 15N-IGF-I).

A freshly prepared single point calibrator (SPC) shall be included in each

Calibration analytical batch. The Recombinant Human IGF-I calibrator from NIST
(SRM 2926 iv) should be used to prepare the SPC. Any other calibration
material shall be validated against the NIST SRM 2926 calibrator.

Applicable links
ii
https://shop.nist.gov/ccrz__ProductDetails?sku=2927&cclcl=en_US
iii
https://www.prospecbio.com/igf1_n15_human
iv
https://shop.nist.gov/ccrz__ProductDetails?sku=2926&cclcl=en_US

ABP Operating Guidelines – Version 9.0 – July 2023 Page 38/91

7.0 Bibliography
1. Guha N, Erotokritou-Mulligan I, Bartlett C, et al. Biochemical markers of insulin-like growth
factor-I misuse in athletes: the response of serum IGF-I, procollagen type III amino-terminal
propeptide, and the GH-2000 score to the administration of rhIGF-I/rhIGF binding protein-3
complex. J Clin Endocrinol Metab. 2014;99(6):2259-2268. doi:10.1210/jc.2013-3897

2. Holt RIG, Sönksen PH. Growth hormone, IGF-I and insulin and their abuse in sport. Br J
Pharmacol. 2008;154(3):542-556. doi:10.1038/bjp.2008.99

3. World Anti-Doping Agency. International Standard for Laboratories - Version 11.0.; 2021.
Accessed June 8, 2023. https://www.wada-ama.org/en/resources/world-anti-doping-
program/international-standard-laboratories-isl#resource-download

4. Powrie JK, Bassett EE, Rosen T, et al. Detection of growth hormone abuse in sport. Growth
Hormone & IGF Research. 2007;17(3):220-226. doi:10.1016/j.ghir.2007.01.011

5. Holt RIG, Erotokritou-Mulligan I, McHugh C, et al. The GH-2004 project: the response of IGF1
and type III pro-collagen to the administration of exogenous GH in non-Caucasian amateur
athletes. European journal of endocrinology. 2010;163(1):45-54. doi:https://doi.org/10.1530/EJE-
09-0978

6. Erotokritou-Mulligan I, Bassett EE, Kniess A, Sönksen PH, Holt RIG. Validation of the growth
hormone (GH)-dependent marker method of detecting GH abuse in sport through the use of
independent data sets. Growth Hormone & IGF Research. 2007;17(5):416-423.
doi:10.1016/j.ghir.2007.04.013

7. Longobardi S, Keay N, Ehrnborg C, et al. Growth Hormone (GH) Effects on Bone and Collagen
Turnover in Healthy Adults and Its Potential as a Marker of GH Abuse in Sports: A Double Blind,
Placebo-Controlled Study. J Clin Endocrinol Metab. 2000;85(4):1505-1512.
doi:10.1210/jcem.85.4.6551

8. Wallace JD, Cuneo RC, Lundberg PA. Responses of Markers of Bone and Collagen Turnover to
Exercise, Growth Hormone (GH) Administration, and GH Withdrawal in Trained Adult Males.
2000;85(1):10.

9. Wallace JD, Cuneo RC, Baxter R, et al. Responses of the Growth Hormone (GH) and Insulin-
Like Growth Factor Axis to Exercise, GH Administration, and GH Withdrawal in Trained Adult
Males: A Potential Test for GH Abuse in Sport. 1999;84(10):11.

10. Dall R, Longobardi S, Ehrnborg C, et al. The Effect of Four Weeks of Supraphysiological Growth
Hormone Administration on the Insulin-Like Growth Factor Axis in Women and Men. J Clin
Endocrinol Metab. 2000;85(11):4193-4200. doi:10.1210/jcem.85.11.6964

11. Nelson AE, Meinhardt U, Hansen JL, et al. Pharmacodynamics of growth hormone abuse
biomarkers and the influence of gender and testosterone: a randomized double-blind placebo-
controlled study in young recreational athletes. J Clin Endocrinol Metab. 2008;93(6):2213-2222.
doi:10.1210/jc.2008-0402

ABP Operating Guidelines – Version 9.0 – July 2023 Page 39/91

12. Moncrieffe D, Cox HD, Carletta S, et al. Inter-Laboratory Agreement of Insulin-like Growth
Factor 1 Concentrations Measured Intact by Mass Spectrometry. Clinical Chemistry.
2020;66(4):579-586. doi:10.1093/clinchem/hvaa043

13. Knudsen CS, Heickendorff L, Nexo E. Measurement of amino terminal propeptide of type III
procollagen (PIIINP) employing the ADVIA Centaur platform. Validation, reference interval and
comparison to UniQ RIA. Clinical Chemistry and Laboratory Medicine (CCLM). 2014;52(2):237-
241. doi:10.1515/cclm-2013-0502

14. World Anti-Doping Agency. Technical Document - Minimum Criteria for Chromatographic-Mass
Spectrometric Confirmation of the Identity of Analytes for Doping Control Purposes.; 2023.
Accessed January 24, 2023. https://www.wada-ama.org/en/resources/lab-
documents/td2023idcr#resource-download

15. Equey T, Pastor A, de la Torre Fornell R, et al. Application of the Athlete Biological Passport
Approach to the Detection of Growth Hormone Doping. J Clin Endocrinol Metab.
2022;107(3):649-659. doi:10.1210/clinem/dgab799

16. World Anti-Doping Agency. International Standard for Testing and Investigations. Published
2023. Accessed June 6, 2023. https://www.wada-ama.org/en/resources/world-anti-doping-
program/international-standard-testing-and-investigations-isti

17. Holt RIG, Böhning W, Guha N, et al. The development of decision limits for the GH-2000
detection methodology using additional insulin-like growth factor-I and amino-terminal pro-
peptide of type III collagen assays. Drug Test Anal. 2015;7(9):745-755. doi:10.1002/dta.1772

ABP Operating Guidelines – Version 9.0 – July 2023 Page 40/91

3.5. Laboratory Guidelines - Quantification of
Endogenous Steroids in Blood for the Athlete
Biological Passport

1.0 Objective
These Laboratory Guidelines have been developed to ensure a harmonized application of the
Analytical Testing Procedure for the quantification of endogenous steroid Markers measured in blood
(serum) as part of the Steroidal Module of the Athlete Biological Passport (ABP). The document
provides guidance on the pre-analytical details, Sample preparation procedure, the performance of
the analyses and the reporting of the test results.

2.0 Scope
These Laboratory Guidelines contain requirements for the implementation of the Analytical Testing
Procedure for the quantification of endogenous steroid Markers in blood (serum) as part of the
Steroidal Module of the ABP to uncover use of endogenous anabolic androgenic steroids (EAAS)
administered exogenously. These Laboratory Guidelines follow the rules established in the WADA
International Standard for Laboratories (ISL) 1 and relevant Technical Documents (TDs) regarding the
Analytical Testing of blood Samples.

3.0 Introduction to the Analytical Testing Procedure

The Analytical Testing Procedure involves the measurement of two (2) Markers, namely Testosterone
(T) and Androstenedione (Androst-4-ene-3,17-dione, A4), which are naturally present in blood, and
the calculation of the T/A4 ratio. While the endogenous levels of these Markers are gender-specific,
they have been identified as relevant target Analytes to detect T abuse with an increased sensitivity
in female Athletes 2,3, as well as the transdermal application of T-related drugs in both genders 4–6.
The quantification of T and A4 concentrations is based on Liquid Chromatography (LC) combined
with tandem Mass Spectrometry (LC-MSn; n ≥ 1). For the purposes of the ABP, an initial
quantification from the “A” Sample is performed. When requested, a confirmatory quantification of
the “A” Sample may additionally be performed (see Article 6.2) to confirm the concentrations and to
perform identification of the Markers (as per TD IDCR7).
The concentrations of T and A4 in blood reported by the Laboratories are integrated in the Steroidal
Module of ADAMS, using a similar Bayesian approach to that applied in the other Steroidal (urine),
Hematological and Endocrine Modules of the ABP.

ABP Operating Guidelines – Version 9.0 – July 2023 Page 41/91

4.0 Assay Pre-analytical Procedure
− The Laboratory should (usually) receive refrigerated (not frozen i) “A” and “B” blood
Samples, which have been collected in blood tubes containing an inert polymeric serum
separator gel and a clotting activation factor (for example: BD Vacutainer® SSTTM-II Plus
tubes, EU ref 367955; BD Vacutainer® SSTTM-II Plus Advance tubes, EU ref 367954; BD
Vacutainer® SSTTM tubes, US ref 367986) in accordance with the International Standard
for Testing and Investigation (ISTI) 7;
− Alternatively, if the clotting and centrifugation of the Sample is performed prior to reception
at the Laboratory (for example, at the site of Sample collection), Samples may be received
at the Laboratory as frozen/refrigerated blood Samples either in the same Sample
collection tubes or as separated serum in new tubes;
− The Laboratory shall check the status of the Sample(s) (e.g., evidence of hemolysis) and
the integrity of the collection tubes (e.g., evidence of breakage of the separating gel). The
Laboratory shall note any unusual condition of the Sample and record such condition(s) in
the Test Report in ADAMS;
− Any Samples delivered to the Laboratory in tubes containing an anti-coagulant (for
example, ABP blood Samples collected in EDTA tubes), or as separated plasma, shall not
be analyzed for Markers of the Endocrine Module;
− The Laboratory shall notify and seek advice from the Testing Authority regarding rejection
or Analytical Testing of Samples for which irregularities are noted (see ISL 1).

4.1 Samples received as non-separated blood in tubes containing an inert polymeric serum
separator gel and a clotting activation factor:
Reception Both Samples “A” and “B” shall be centrifuged for 10-15 min at 1300-1500 g
as soon as possible after reception at the Laboratory.
The “A” Sample shall be used for the initial and confirmatory (if needed)
quantifications (see below).
The “B” Sample shall be step-frozen and stored until use, if needed (see
below).
Aliquoting and An Aliquot of the “A” Sample serum shall be taken for initial quantification.
analysis The remaining “A” serum fraction may be kept in the Sample collection tube or
aliquoted into new vials with label(s) ensuring that Laboratory Internal Chain of
Custody is maintained.

i unless the blood matrix components have been separated before shipment to the Laboratory.

ABP Operating Guidelines – Version 9.0 – July 2023 Page 42/91

 For initial quantification:
• the Aliquot may be analyzed immediately after aliquoting; or
• the Aliquot shall be stored at approximately 4 °C°C if analyzed within 24h
(within a maximum of five (5) days from Sample collection); or
• the Aliquot shall be frozen (-20°C) if the analysis will be conducted more
than 24h after aliquoting.
For the confirmatory quantification, a new Aliquot of the “A” Sample shall be
analyzed immediately after aliquoting.
[Comment: When analyses specific to the ABP are requested for blood (serum) Samples (i.e.,
Markers of the Endocrine Module or blood steroid Markers as part of the Steroidal Module), only
the “A” Sample should be considered for the initial and the confirmatory quantifications of the
Markers. In cases where the “A” Sample is not suitable for the performance of ABP Markers
quantification (e.g., there is insufficient Sample volume; the Sample container has not been
properly sealed or has been broken; the Sample’s integrity has been compromised in any way; the
“A” Sample is missing), a splitting procedure of the “B” Sample could be performed, as detailed in
the ISL1.]

Storage Storage for up to three (3) months  at approximately -20 °C.

[The same storage Storage for more than three (3) months  freeze at approximately -20 °C and
conditions apply for
transfer to approximately -70 to -80 °C.
Samples received
in conditions [Comment: If the separated serum fraction is kept in the Sample collection tube, it shall be step-
described in frozen for storage according to the tube manufacturer’s instructions until analysis.
section 4.2]
If the Laboratory transfers the Aliquot into new vials for frozen storage, the vials should ensure
proper sealing for optimal storage (cryovials with an “O-ring”).
Thawing of Sample(s) for analysis should also be done stepwise. Samples shall not be thawed
under hot water or any other similar process that risks raising the temperature of the Sample
above room temperature. Thawing overnight at 4°C is recommended.]

4.2 Samples received as frozen/refrigerated centrifuged blood/serum Samples:

Reception If Samples are received frozen, they should remain frozen until analysis as
described in this Article 4.2.
If Samples are received refrigerated, they should be processed as soon as
possible as per Article 4.1.
Aliquoting and Once the Sample “A” is thawed, an Aliquot shall be taken for initial
analysis quantification. This Aliquot may be stored at approximately 4 °C for a maximum
of 24h before analysis.
The remaining “A” serum fraction may be kept in the Sample collection tube or
aliquoted into new vial(s) with label(s) ensuring Laboratory Internal Chain of
Custody is maintained.
For the confirmatory quantification, a new Aliquot of the “A” Sample shall be
analyzed immediately after aliquoting.

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5.0 Analytical Testing Procedure Requirements
5.1 Analytical Testing Procedure Validation Requirements
Prior to the implementation of the Analytical Testing Procedure for the quantification of
blood endogenous steroids in routine Doping Control analysis, the Laboratory shall fulfil
the following requisites:
− Validate the Analytical Testing Procedure, including the determination of the assays’
Limit of Quantification (LOQ), Repeatability (sr), Intermediate Precision (sw), Bias and
Measurement Uncertainty (uc);
− The Analytical Testing Procedure shall meet the acceptance values for the
parameters of assay performance applicable to the separate determination of T and
A4 concentrations as specified in Table 1 below.
5.2 Analytical Testing Procedure Accreditation Requirements
− Demonstrate readiness for assay implementation through method validation data and
successful participation in at least one WADA-approved educational External Quality
Assessment Scheme (EQAS) round or inter-Laboratory collaborative study. In cases
of identified deficiencies, proper corrective action(s) shall be documented and
implemented;
− Obtain ISO/IEC 17025 accreditation for the Analytical Testing Procedure for
quantification of endogenous steroids in blood from an Accreditation Body that is a
full member of the International Laboratory Accreditation Cooperation (ILAC) and a
signatory to the ILAC Mutual Recognition Agreement (ILAC MRA).

6.0 Analytical Testing Procedure and Reporting of Test Results

6.1 Initial Quantification of the Markers
− One (1) Aliquot taken from the original “A” Sample shall be analyzed once (x1) to
quantify T and A4;
− QC Sample(s), at low- and high-levels of the Markers (see Table 1), shall be included
in each initial quantification analytical batch;
− The T and A4 Marker concentrations shall be reported in ADAMS in nanograms per
milliliter (ng/mL);
[Comment: for the purposes of the Steroidal Module of the ABP, the T/A4 ratio does not need
to be calculated or reported by the Laboratory; it will be automatically calculated in ADAMS].

− If the measured Marker concentration is below the LOQ of the assay, the Laboratory
shall report a value of “-1” for its concentration in ADAMS and the Laboratory shall
make a comment in the Test Report on why the Marker could not be quantified (e.g.,
the measurement of the Marker is not possible due to unusual matrix interferences);
− An observation of hemolysis of the Sample should be recorded in the comments
section of the Laboratory Test Report in ADAMS.

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 6.2 Confirmatory Quantification of the Markers
If requested by the Testing Authority (TA), Results Management Authority (RMA) or
WADA, the Laboratory shall proceed with the confirmatory quantification of the Markers
of the blood Steroidal Module.
[Comment: An APMU or Passport Custodian (PC), where the PC is not the TA, may request a
confirmatory quantification on behalf of the TA or RMA. In such cases, the APMU or PC shall copy
the relevant TA or RMA, as applicable, on all written requests to the Laboratory for confirmatory
quantification.]

When a confirmatory quantification analysis is requested:

− One (1) new Aliquot taken from the original “A” Sample shall be analyzed once (x1) to
identify (as per the TD IDCR 8) and to quantify T and A4.
− At least one QC Sample (see Table 1), depending on initial quantification results, shall
be included in each confirmatory quantification analytical batch;
− The T and A4 Marker concentrations shall be reported in ADAMS in nanograms per
milliliter (ng/mL).
− If the measured Marker concentration is below the LOQ of the assay, the Laboratory
shall report a value of “-1” for its concentration in ADAMS and the Laboratory shall
make a comment in the Test Report on why the Marker could not be quantified (e.g.,
the measurement of the Marker is not possible due to unusual matrix interferences);
− An observation of hemolysis of the Sample should be recorded in the comments
section of the Laboratory Test Report in ADAMS.

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Table 1: Analytical Testing Procedure Validation and Performance Requirements for the initial and
confirmatory quantification of blood (serum) endogenous steroid Markers.

Testosterone (T), total unconjugated fraction

Markers
Androstenedione (Androst-4-ene-3,17-dione, A4), total unconjugated fraction

Method and Liquid Chromatography combined with tandem Mass Spectrometry based on
Instrumentation triple quadrupole or HRMS analyzer (LC-MSn; n ≥ 1).

Shall cover the ranges of Marker concentrations normally found in males and
Range of the Method females and demonstrate linearity between 0.1 – 10 ng/mL (~ 0.35 – 35
nmol/L), at least.
The LOQ shall be determined during method validation and is defined as the
Limits of lowest concentration with an associated uc (%) not greater than (≤) 30% and
Quantification (LOQ) shall be not greater than (≤) 0.1 ng/mL (~ 0.35 nmol/L).

Relative Standard
The estimated uc (%) shall be no greater than (≤) 30% at the LOQ; and not
Combined
greater than (≤) 20% when the Marker concentration is greater than (>) 0.3
Measurement
ng/mL.
Uncertainty, uc (%)

Sample Marker quantification shall be conducted on one serum Aliquot of no greater

than (≤) 100 μL.

Internal Standards Adequate isotopic-labelled internal standards shall be used for both Markers
(e.g., Testosterone-d3 (16,16,17-d3) ii and Androstenedione-d3 (19-d3) iii).
Calibration standard(s) shall be included in each sequence of analysis. The
Calibration “Multilevel Serum Calibrator Set” from Chromsystem iv is recommended. Other
calibrators may be used as long as the method performance criteria are met.
At least two (2) quality control (QC) samples in serum containing representative
low (e.g., 0.5 ng/mL) and high (e.g., 5 ng/mL) concentrations of the Markers
Quality Control shall be included in each analytical batch. The QCs should be prepared from
authentic samples, or by spiking with a standard solution independent from that
used for the calibrator(s).

Applicable links:
ii
https://www.lipomed-usa.com/en/testosterone-d3, for example.
iii
https://www.lgcstandards.com/US/en/Androstenedione-d3/p/TRC-A637552-1MG, for example.
iv
https://chromsystems.com/en/6plus1r-multilevel-serum-calibrator-set-masschromr-steroid-panel-2-72039.html

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7.0 Bibliography
1. World Anti-Doping Agency. International Standard for Laboratories - Version 11.0.; 2021.
Accessed June 8, 2023. https://www.wada-ama.org/en/resources/world-anti-doping-
program/international-standard-laboratories-isl#resource-download

2. Elings Knutsson J, Andersson A, Baekken LV, Pohanka A, Ekström L, Hirschberg AL. Disposition
of Urinary and Serum Steroid Metabolites in Response to Testosterone Administration in Healthy
Women. J Clin Endocrinol Metab. 2021;106(3):697-707. doi:10.1210/clinem/dgaa904

3. Salamin O, Nicoli R, Langer T, et al. Longitudinal evaluation of multiple biomarkers for the
detection of testosterone gel administration in women with normal menstrual cycle. Drug Test
Anal. Published online April 5, 2021. doi:10.1002/dta.3040

4. Ponzetto F, Mehl F, Boccard J, et al. Longitudinal monitoring of endogenous steroids in human

serum by UHPLC-MS/MS as a tool to detect testosterone abuse in sports. Anal Bioanal Chem.
2016;408(3):705-719. doi:10.1007/s00216-015-9185-1

5. Nair VS, Sharpe K, Husk J, et al. Evaluation of blood parameters by linear discriminant models
for the detection of testosterone administration. Drug Test Anal. 2021;13(7):1270-1281.
doi:10.1002/dta.3017

6. Handelsman DJ, Bermon S. Detection of testosterone doping in female athletes. Drug Test Anal.
Published online September 3, 2019:dta.2689. doi:10.1002/dta.2689

7. World Anti-Doping Agency. International Standard for Testing and Investigations. Published
2023. Accessed June 6, 2023. https://www.wada-ama.org/en/resources/world-anti-doping-
program/international-standard-testing-and-investigations-isti

8. World Anti-Doping Agency. Technical Document - Minimum Criteria for Chromatographic-Mass

Spectrometric Confirmation of the Identity of Analytes for Doping Control Purposes.; 2023.
Accessed January 24, 2023. https://www.wada-ama.org/en/resources/lab-
documents/td2023idcr#resource-download

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3.6. Measurement and Reporting of Endogenous
Anabolic Androgenic Steroid (EAAS) Markers of
the Urinary Steroid Profile
WADA Technical Document – TD2021EAAS
Document Number: TD2021EAAS Version Number: 2.0

Written by: WADA Science/EAAS Working Group

Approved by: WADA Executive Committee
Reviewed by: WADA Laboratory Expert Group
Date: 20 May 2021 Effective Date: 1 June 2021

1.0 Introduction
The purpose of this Technical Document (TD) is to harmonize the measurement and reporting of the
“steroid profile” of urine Samples in support of the steroidal module of the Athlete Biological Passport
(ABP) (the steroidal Passport).
1.1 The Steroid Profile
The measurement of steroidal Markers [concentrations and ratios of defined Endogenous Anabolic
Androgenic Steroids (EAAS)] in a urine Sample form the steroid profile for that Sample (see Table 1).
The steroid profiles of a series of urine Samples collected from an Athlete over a period of time
constitute the steroidal Passport of that Athlete.
The administration of synthetic forms of EAAS can alter one or more of the Markers of the urinary
steroid profile, resulting in increased or decreased concentrations and/or ratios of specific pairs of
steroid Markers [1-3]. This effect forms the basis for the use of the steroidal Passport as a tool for the
detection of doping with EAAS, in particular testosterone (T), its precursors (for example, 4-
androstenediol, androstenedione and prasterone), its active Metabolite [dihydrotestosterone (DHT)],
or its epimer epitestosterone (E).
The steroidal module of the ABP utilizes the Adaptive Model in ADAMS to trigger Atypical Passport
Findings (ATPFs), which can lead to the performance of Confirmation Procedures (CP), Target
Testing of an Athlete, or to establish Use of a Prohibited Substance and/or Prohibited Method as per
Code Article 2.2 (see International Standard for Results Management, Annex C [4]).

1.2 Procedure for Determination of the Steroid Profile

Each urine Sample shall be analyzed to determine its steroid profile. The determination and reporting
of a Sample’s steroid profile follows a two-step procedure:
i. An Initial Testing Procedure (ITP) is conducted to estimate the steroid profile of the Sample,
and

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 ii. A subsequent CP is performed when the reported steroid profile constitutes an ATPF, as
determined by the Adaptive Model, or upon request from the Athlete Passport Management
Unit (APMU), the Testing Authority or WADA.

Table 1. Markers of the Urinary Steroid Profile.

Type of Marker Steroid Profile Markers Determination

- Androsterone (A);
- Etiocholanolone (Etio);
- 5α-Androstane-3α,17β-diol Determined by the Laboratory by GC-MSn from
Concentrations of (5αAdiol); the combination of the free steroid fraction and the
conjugated fraction released after hydrolysis with
Steroids - 5β-Androstane-3α,17β-diol
β-glucuronidase from E. coli.
(5βAdiol);
- Testosterone (T); and
- Epitestosterone (E).

- T/E As reported by the Laboratory in ADAMS.

- A/T;
Ratios of Steroids Automatically computed in ADAMS from
- A/Etio;
respective steroid concentrations after the
- 5αAdiol/5βAdiol; and reporting of the steroid profile by the Laboratory.
- 5αAdiol/E
1.3 Factors Impacting the Steroid Profile
In addition to the effects mediated by the administration of EAAS, alteration of the urinary steroid
profile can occur for a number of other reasons including, but not limited to, the following factors [1-3]:
• Intake of alcohol (ethanol);
• The administration of other anabolic androgenic steroids (e.g. stanozolol);
• The administration of human chorionic gonadotrophin (hCG) in males;
• The administration of aromatase inhibitors and anti-estrogenic substances;
• The administration of inhibitors of 5α-reductase (e.g. finasteride, dutasteride);
• The administration of ketoconazole or other similar compounds (e.g. fluconazole, miconazole);
• The use of masking agents (e.g. probenecid) and diuretics;
• Microbial activity;
• Sample manipulation.

2.0 Initial Testing Procedure (ITP)

2.1 ITP Method Requirements

The quantification of the Markers of the steroid profile shall be based on gas chromatography
combined with mass spectrometry (GC-MSn; n ≥ 1).

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Table 2. Requirements of the ITP for Quantification of the Markers of the Steroid Profile.

2.1.1 ITP Validation Requirements

Shall cover the ranges of Marker concentrations normally found in males and
Range of the Method
females.

Assess the efficiency of the enzymatic hydrolysis using β-glucuronidase from

Enzymatic Hydrolysis
E. coli

Derivatization Assess the efficiency of the trimethylsilyl (TMS) derivatization

The LOQ shall be determined during method validation as the lowest

concentration that can be measured with an uc (%) not greater than (≤) 30%
Limits of and shall meet the following criteria:
Quantification (LOQ) • T, E ≤ 1 ng/mL;
• 5αAdiol, 5βAdiol ≤ 10 ng/mL;
• A, Etio ≤ 500 ng/mL

Adiols
A Etio T E T/E
(5α-, 5β-)
Level
The estimated uc (%) shall be not greater than (≤) the uc_Max (%) value
given below
Measurement
Uncertainty, uc (%) at LOQ ≤ 30%
at 5 x LOQ ≤ 20% ≤ 25%
(T, E) > 5 ng/mL ≤ 15%
(T, E) ≤ 5 ng/mL ≤ 30%

2.1.2 ITP Analysis Requirements

The ITP for the quantification of the Markers of the steroid profile shall be
Sample conducted on a single Aliquot. When needed, the volume of the Aliquot may
be adjusted as a function of its specific gravity (SG) and of the sex of the
Athlete.

Calibration Calibration standard(s) or a calibration curve shall be included in each

sequence of analysis.
At least two (2) quality control (QC) urine samples containing representative
Quality Control low and high concentrations of the Markers of the steroid profile shall be
included in each sequence of analysis.
Purified β-glucuronidase from E. coli shall be used for the hydrolysis of the
glucuroconjugated urinary steroids, and the completeness of hydrolysis shall
Enzymatic Hydrolysis be monitored in each Aliquot with isotopically labeled
A-glucuronide (or an equivalent scientifically recognized alternative).
H. pomatia mixtures shall not be used.

Derivatization The Markers of steroid profile shall be analyzed as TMS derivatives (TMS
enol ethers and/or TMS ethers).

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 Completeness of the derivatization shall be controlled in each Aliquot through
the monitoring of mono-O-TMS vs. di-O-TMS derivative of A.
The T/E ratios shall be determined from the ratios of chromatographic peak
T/E Ratio areas or peak heights after correction against a calibrator or a calibration
curve.
The Laboratory shall:
• Monitor for signs of microbial activity [e.g. presence of indicators of 3α-
hydroxysteroid dehydrogenase (HSD) activity];
Factors Impacting the
[Comment: The direct enzymatic hydrolysis of urine Samples may increase the
Steroid Profile effects of microbial contamination.]
Test for the presence of conjugated Metabolite(s) of ethanol [e.g. ethanol
glucuronide (EtG)], 5α-reductase inhibitors (e.g. finasteride, dutasteride) and
ketoconazole (and similar substances).

2.2 Reporting the Sample’s Steroid Profile from the ITP

Following the performance of the ITP, the Laboratory shall report in ADAMS the steroid profile for
each Sample analyzed.
The Laboratory shall report in ADAMS:
i. The SG of the Sample, as determined by the Laboratory (see TD DL [5]);
ii. The uncorrected concentrations of T, E, A, Etio, 5αAdiol and 5βAdiol, and the T/E ratio;
[Comment: When the ITP measurement of a steroid profile Marker is not possible due to, for example,
dilution, unusual matrix interferences, inhibition of the enzymatic hydrolysis or incomplete derivatization,
the Laboratory should repeat the analysis with an alternative Sample preparation procedure (e.g. changing
Aliquot volumes, application of solid phase extraction, or extraction with a different solvent).
If, however, a Marker of the steroid profile cannot be quantified, the concentration of the affected Marker
shall be reported as “-1”. The Laboratory shall make a comment in the Test Report on why this Marker
could not be quantified (e.g. < LOQ, incomplete derivatization).
When the chromatographic peak signal for a Marker cannot be detected (i.e. is below the detection
capability of the assay), the concentration of the Marker shall be reported as “-2” (See Table 3 for reporting
of specific situations for [T], [E], and T/E).
The Laboratory may also provide information on other steroidal parameters such as prasterone (DHEA),
dihydrotestosterone (DHT) and 6α-hydroxy-androstenedione (6α-OH-AD) at the request of the Testing
Authority, Results Management Authority or the APMU.]
iii. Any signs of microbial activity in the Sample, e.g. ratios of 5α-androstanedione (5αAND) to A
and 5β-androstanedione (5βAND) to Etio, as determined from the respective steroid
concentrations;
iv. The presence or absence in the Sample of substance(s) that may alter the steroid profile (see
Article 1.3). The Laboratory shall report the estimated levels of:
• EtG if ≥ 5 µg/mL;
• Carboxy-finasteride if ≥ 5 ng/mL;
• 4-hydroxy- and/or 6-hydroxy-dutasteride if ≥ 5 ng/mL;
• Ketoconazole if ≥ 100 ng/mL;

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 • Fluconazole if ≥ 500 ng/mL;
• Miconazole if ≥ 1,000 ng/mL.

2.2.1 Validity of the Sample Steroid Profile

The validity of the Sample will be determined automatically upon reporting of the steroid profile in
ADAMS. A Sample will be invalid only when the Sample shows signs of extensive degradation, as
determined by:
• 5αAND/A ≥ 0.1, and/or
• 5βAND/Etio ≥ 0.1
[Comment: In addition, following the reporting of the steroid profile in ADAMS by the Laboratory, the
Sample may be evaluated as “invalid” by the APMU upon review of the steroid profile data, for example,
by considering the presence of substances that may alter the steroid profile in the Sample.]

Table 3. Summary of conditions for reporting T and E concentrations and T/E ratio.

Concentration of T Concentration of E T/E ratio

Chromatographic peak signal of E
measured at or above (≥) LOQ.

[E] ≥ LOQ(E)
Chromatographic peak Report E as measured. Report T/E
signal of T measured
at or above (≥) the Chromatographic peak signal of E (as determined by the Laboratory from
LOQ. detected, but below (<) LOQ. corrected peak heights/areas)

LOD(E) ≤ [E] < LOQ(E)

[T] ≥ LOQ(T)
Report E as “-1”
Chromatographic peak signal of E not Report T/E as “-1”
Report T as detected.
measured Report the LOD(E)

[E] < LOD(E)

Comment in ADAMS:
Report E as “-2”
T/E ratio could not be measured accurately
because E could not be detected.

Chromatographic peak signal of E

Chromatographic peak measured at or above (≥) LOQ.
signal of T detected,
but below (<) the LOQ. [E] ≥ LOQ(E)
Report T/E
Report E as measured
(as determined by the Laboratory from
LOD(T) ≤ [T] < LOQ(T) Chromatographic peak signal of E
corrected peak heights/areas)
detected, but below (<) LOQ.

Report T as “-1” LOD(E) ≤ [E] < LOQ(E)

Report E as “-1”

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 Chromatographic peak signal of E not Report T/E as “-1”
detected.

Comment in ADAMS:
[E] < LOD(E)
T/E ratio could not be measured accurately
Report E as “-2” because the concentration of T could not be
measured, and E could not be detected

Chromatographic peak signal of E Report T/E as “-1”

measured at or above (≥) LOQ. Report the LOD(T)

[E] ≥ LOQ(E)
Comment in ADAMS:
Report E as measured
T/E ratio could not be measured accurately
because T could not be detected
Chromatographic peak Chromatographic peak signal of E Report T/E as “-1”
signal of T not detected but below (<) LOQ. Report the LOD(T)
detected.
LOD(E) ≤ [E] < LOQ(E)
Comment in ADAMS:
[T] < LOD(T) Report E as “-1”
T/E ratio could not be measured because T
could not be detected, and E could not be
Report T as “-2” measured.
Chromatographic peak signal of E not Report T/E as “-2”
detected. Report the LOD(E) and LOD(T)

[E] < LOD(E)

Comment in ADAMS:
Report E as “-2”
T/E ratio could not be measured because T and
E could not be detected.

3.0 Confirmation Procedures (CP)

The CP for the EAAS Markers include the GC-MSn (n ≥ 1) identification (in compliance with the TD
IDCR [6]) and quantification, as well as the GC/C/IRMS analysis [7] of the Marker(s) of the steroid
profile.
In addition, the Laboratory shall confirm the presence or absence of factors impacting the steroid
profile (see Article 1.3).

3.1 CP Requests (CPRs)

3.1.1 CPRs triggered by Atypical Passport Findings (ATPF) through ADAMS

Once the Sample’s steroid profile data are entered in ADAMS and matched with an Athlete, the
Adaptive Model automatically updates the steroidal Passport. If an ATPF is identified based on an
abnormally high T/E value, a CP request (ATPF-CPR) is triggered and sent automatically to
Laboratories through ADAMS.
Upon receipt of an ATPF-CPR, the Laboratory shall proceed with the CP of the steroid profile as soon
as possible, unless the presence of ethanol or other factors impacting the steroid profile has been
detected in the Sample. In such cases, the Laboratory shall receive, within fifteen (15) days from the

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ATPF-CPR notification, an advice from the Passport Custodian or the Testing Authority (or Results
Management Authority, if different) on whether to proceed or not with the CP of the Sample’s steroid
profile.
[Comment: In the absence of communication from the Passport Custodian or the Testing Authority (or
Results Management Authority) within fifteen (15) days from the ATPF-CPR notification, the Laboratory
shall proceed with the CP of the steroid profile (see Article 3.2)].
Any justification from the Passport Custodian or the Testing Authority (or Results Management
Authority) not to proceed with the CP shall be provided in writing and in compliance with the TD APMU
[8].

[Comment: In cases when the Laboratory is instructed by the Passport Custodian or the Testing Authority
(or Results Management Authority) not to perform the CP, the Laboratory shall update the ADAMS Test
Report for the Sample with a comment stating that the Passport Custodian, Testing Authority (or Results
Management Authority) requested not to perform the CP, and the reasons given.]
When the Laboratory receives an ATPF-CPR for a Sample for which Adverse Analytical Finding(s)
(AAF) have been reported for other Prohibited Substance(s) or Method(s), the Laboratory shall
consult the Testing Authority (or Results Management Authority, if different) about the need to conduct
the CP for the Markers of the steroid profile.

3.1.2 CPRs from the APMU, the Testing Authority (or Results Management Authority, as applicable)
or WADA.
The Adaptive Model will also determine abnormal values or sequences of the other ratios of the
“steroid profile” (A/T, A/Etio, 5αAdiol/5βAdiol, 5αAdiol/E). However, in such cases the Laboratory will
not receive an automatic “ATPF-CPR” notification through ADAMS. Instead, the APMU will advise the
Testing Authority (or Results Management Authority, if different) on whether the Sample shall be
subjected to CP. Therefore, in these cases the Laboratory shall receive a written request from the
Testing Authority (or Results Management Authority, if different) before proceeding with the CP.
In the absence of an ATPF-CPR, requests for CP can be made also by the Testing Authority (or
Results Management Authority, if different), the APMU *, or WADA.
* where the respective client of the APMU has agreed to bestow such authority to the APMU.

3.2 CP Test Methods

3.2.1 CP of Steroid Profile Markers by GC-MSn
The Laboratory shall quantify all the Markers of the steroid profile in one Aliquot by a validated Fit-
for-Purpose GC-MSn (n ≥ 1) quantification method. Identification (in compliance with the TD IDCR [6])
of the Markers that triggered the CP shall be performed as well.
• In every case, the Laboratory shall confirm quantitatively all the Markers of the steroid profile
before proceeding with the GC/C/IRMS analysis;
[Comment: This requirement does not apply if the Testing Authority (or Results Management Authority,
as applicable) has authorized the Laboratory to proceed directly to GC/C/IRMS analysis without a need
for a quantitative confirmation of the steroid Markers (for example, in cases of limited Sample volume).

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 For T/E values, only T needs to be confirmed if E is not detected or the volume of the Sample is not
sufficient.]
• In the case of an ATPF-CPR for an abnormally high T/E ratio, GC/C/IRMS analysis is not
mandatory when the confirmed T/E value is below the confirmation T/E cut-off calculated by the
Adaptive Model and provided within the ATPF-CPR notification received from ADAMS;
• For other CP requests, when the steroid profile CP does not confirm the ITP values that triggered
the CP (e.g. 5αAdiol/E value), taking into consideration the expanded uncertainty of the
measurement (U95%, k = 2), the Laboratory shall consult the Testing Authority to determine if the
GC/C/IRMS analysis is necessary. In the event that GC/C/IRMS analysis is deemed unnecessary,
the Laboratory shall update the ADAMS report for the Sample with the confirmed values of all the
Markers of the steroid profile and include a comment that GC/C/IRMS analysis was not necessary.
[Comment: for ratios other than the T/E, the uc (%) of the ratio shall be calculated by propagation of
uncertainties of the corresponding Marker concentrations.]
The same analytical requirements presented in Table 2 for the ITP shall apply for the GC-MSn CP,
with the following modifications:
• GC-MSn CP Validation Requirements
- For determinations of A, Etio, 5αAdiol and 5βAdiol, the uc (%) shall be not greater than (≤)
15% when the concentrations are five times (5x) the respective LOQ;
- For determinations of T, E and T/E ratios, the uc (%) shall be not greater than (≤) 15% when
the concentrations of T and E are greater than (>) 5 ng/mL.
• GC-MSn CP Analysis Requirements
- A Solid Phase Extraction (SPE) shall be performed prior to the enzymatic hydrolysis of the
Sample;
- Calibration standard(s) and at least two (2) QC urine samples containing representative low
and high levels of the Markers of the steroid profile shall be included.

3.2.2 GC/C/IRMS CP
Technical and reporting requirements for the GC/C/IRMS CP are specified in the
TD IRMS [7].
When an AAF is reported for the Marker(s) of the steroid profile based on the results of a GC/C/IRMS
analysis performed on the “A” Sample, only the GC/C/IRMS analysis, including the identification of
the relevant Markers (target compounds and endogenous reference compounds) shall be repeated
during the “B” Sample CP.

3.3 Reporting Results from the CP

3.3.1 “A” Sample
Following the CP performed for the steroid profile on the “A” Sample, the Laboratory shall report in
ADAMS:

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 i. The SG of the Sample (determined from a new Aliquot of the “A” Sample);
ii. The confirmed value of the Markers of the steroid profile (concentrations, T/E value), without
adjustment for the SG of the Sample;
iii. The associated uc (expressed in units);
iv. The GC/C/IRMS confirmation results, if performed (see TD IRMS [7]). The Laboratory shall update
the Test Report for the Sample in ADAMS (as AAF, Atypical Finding (ATF), or Negative Finding)
based on the results of the GC/C/IRMS CP;
v. The confirmed results (presence/absence) for signs of microbial activity: 5αAND/A, 5βAND/Etio,
and Tfree/Ttotal; based on concentrations;
[Comment: In addition to the determination of the 5αAND/A and 5βAND/Etio ratios as signs of microbial
contamination, the determination during the CP of an elevated ratio of free Testosterone to total
Testosterone (Tfree / Ttotal > 0.05) will also invalidate (the steroid profile of) the Sample. However, this shall
not preclude the performance of the GC/C/IRMS CP or invalidate its results.]
vi. The presence or absence in the Sample of substance(s) that do not constitute an AAF but may
alter the steroid profile (see Article 1.3): if detected in the Sample, the Laboratory shall report the
confirmed estimated levels of EtG, 5α-reductase inhibitors and -azoles as specified in Article 2.2
(without the need to report the uc for these determinations).

3.3.2 “B” Sample

Following the performance of the GC/C/IRMS CP for the steroid profile on the “B” Sample, the
Laboratory shall report the GC/C/IRMS confirmation results (see TD IRMS [7]) in ADAMS.
[Comment: If the Sample has not been reported as an AAF for the Marker(s) of the steroid profile based
on the results of the GC/C/IRMS analysis, but the steroid profile CP by GC-MSn has been requested for
the “B” Sample, then the Laboratory shall report in ADAMS the results of the “B” confirmation of the steroid
profile as described for the “A” Sample in Article 3.3.1.]

4.0 Reporting Sample Manipulation (Tampering or Attempted Tampering)

Tampering or Attempted Tampering aims to alter the integrity and validity of Samples collected during
Doping Control, including, but not limited to Sample substitution with another fluid and urine exchange
and/or adulteration (e.g. addition of proteases to Sample).
[Comment: the substitution of an Athlete’s urine Sample with the urine of another individual (urine
exchange) can be uncovered using the steroidal Passport and confirmed by DNA analysis across multiple
Samples, as described in the TD APMU [8].]
In cases when a Sample is not consistent with human urine (e.g. SG ≤ 1.001, creatinine ≤ 5 mg/dL [9],
non-physiological salt concentration, abnormal pH values, absence or abnormally low levels of
endogenous steroids, corticosteroids, proteins, etc.), the Laboratory shall:
i. Report the finding as an AAF for Tampering or Attempted Tampering (class M2.1 of the
Prohibited List) if the Laboratory can determine the general nature/type of the adulterated
Sample, which is not consistent with human urine (e.g. water, liquor, synthetic urine);
OR

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 ii. Report the finding as an ATF for Tampering or Attempted Tampering and include a comment in
ADAMS advising the Testing Authority to perform further investigations (e.g. additional analyses
on the Sample, Target Testing the Athlete).

5.0 References
[1] Mareck U et al. Factors influencing the steroid profile in doping control analysis. J Mass Spectrom.
43(7):877-91, 2008.
[2] Ayotte C. Detecting the administration of endogenous anabolic androgenic steroids. Handb Exp Pharmacol.
195:77-98, 2010.
[3] Kuuranne T, Saugy M, Baume N. Confounding factors and genetic polymorphism in the evaluation of
individual steroid profiling. Br J Sports Med. 48(10): 848-55, 2014.
[4] The World Anti-Doping Code International Standard for Results Management.
[5] WADA Technical Document TD DL: Decision Limits for the Confirmatory Quantification of Exogenous
Threshold Substances by Chromatography-based Analytical Methods.
[6] WADA Technical Document TD IDCR: Minimum Criteria for Chromatographic-Mass Spectrometric
Confirmation of the Identity of Analytes for Doping Control Purposes.
[7] WADA Technical Document TD IRMS: Detection of Synthetic Forms of Prohibited Substances by
GC/C/IRMS.
[8] WADA Technical Document TD APMU: Athlete Passport Management Unit – Requirements and
Procedures.
[9] Cook J D et al. The Characterization of Human Urine for Specimen Validity Determination in Workplace
Drug Testing: A Review. J Anal Toxicol 24: 579-588, 2000
[Comment: Current versions of WADA Technical Documents may be found at https://www.wada-
ama.org/en/what-we-do/science-medical/laboratories ]

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3.7. Results Management Requirements and
Procedures for the Athlete Biological Passport
(ISRM Annex C)
C.1 Administrative Management

C.1.1 The requirements and procedures described in this Annex apply to all modules of the
Athlete Biological Passport except where expressly stated or implied by the context.
C.1.2 These processes shall be administered and managed by an Athlete Passport
Management Unit on behalf of the Passport Custodian. The Athlete Passport Management
Unit will initially review profiles to facilitate targeting recommendations for the Passport
Custodian when appropriate or refer to the Experts as required. Management and
communication of the biological data, Athlete Passport Management Unit reporting and
Expert reviews shall be recorded in ADAMS and be shared by the Passport Custodian
with other Anti-Doping Organizations with Testing Authority over the Athlete to coordinate
further Passport Testing as appropriate. A key element for Athlete Biological Passport
management and communication is the Athlete Passport Management Unit Report in
ADAMS, which provides an overview of the current status of the Athlete’s Passport
including the latest targeting recommendations and a summary of the Expert reviews.
C.1.3 This Annex describes a step-by-step approach to the review of an Athlete’s Passport:
a) The review begins with the application of the Adaptive Model.

b) In case of an Atypical Passport Finding or when the Athlete Passport Management

Unit considers that a review is otherwise justified, an Expert conducts an initial review
and returns an evaluation based on the information available at that time.

c) In case of a “Likely doping” initial review, the Passport is then subjected to a review
by three (3) Experts including the Expert who conducted the initial review.

d) In case of a “Likely doping” consensus of the three (3) Experts, the process continues
with the creation of an Athlete Biological Passport Documentation Package.

e) An Adverse Passport Finding is reported by the Athlete Passport Management Unit

to the Passport Custodian if the Experts’ opinion is maintained after review of all
information available at that stage, including the Athlete Biological Passport
Documentation Package.

f) The Athlete is notified of the Adverse Passport Finding and offered the opportunity
to provide explanations.

g) If after review of the explanations provided by the Athlete, the Experts maintain their
unanimous conclusion that it is highly likely that the Athlete Used a Prohibited
Substance or a Prohibited Method, an anti-doping rule violation is asserted against
the Athlete by the Passport Custodian.
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C.2 Initial Review Phase

C.2.1 Review by the Adaptive Model

The requirements and procedures described in this Annex apply to all modules of the
Athlete Biological Passport except where expressly stated or implied by the context.
C.2.1.1. In ADAMS, the Adaptive Model automatically processes data on the biological
Markers of the Athlete Biological Passport. These Markers include primary
Markers that are defined as the most specific to doping and secondary Markers
that provide supporting evidence of doping in isolation or in combination with
other Markers. The Adaptive Model predicts for an individual an expected range
within which a series of Marker values falls assuming a normal physiological
condition. Outliers correspond to those values outside of the 99%-range, from
a lower limit corresponding to the 0.5th percentile to an upper limit
corresponding to the 99.5th percentile (1:100 chance or less that this result is
due to normal physiological variation). A specificity of 99% is used to identify
Atypical Passport Findings. In the case of sequence deviations (sequence
Atypical Passport Findings), the applied specificity is 99.9% (1:1000 chance or
less that this is due to normal physiological variation).

C.2.1.2. An Atypical Passport Finding is a result generated by the Adaptive Model in

ADAMS which identifies either:

a) a primary Marker(s) value(s) as being outside the Athlete’s intra-individual

range, or,

b) a longitudinal profile consisting of (up to) the last five (5) valid primary
Marker values as deviating from expected ranges (sequence Atypical
Passport Findings), assuming a normal physiological condition.

An Atypical Passport Finding requires further attention and review.

C.2.1.3. Primary and Secondary Markers

C.2.1.3.1 For the Haematological Module, the Adaptive Model automatically

processes in ADAMS two primary Markers, haemoglobin
concentration (HGB) and stimulation index OFF-score (OFFS), and
two secondary Markers, the reticulocyte percentage (RET%) and
the Abnormal Blood Profile Score (ABPS). HGB and RET% are
Markers measured in blood ABP Samples while OFFS and ABPS
are calculated using values of Markers measured in blood ABP
Samples.

C.2.1.3.2 The Steroidal Module comprises steroid Markers measured in urine

and/or blood (serum) Samples. For urine Samples, the Adaptive
Model automatically processes in ADAMS one primary Marker, the
Testosterone to Epitestosterone ratio (T/E), and four (4) secondary
Markers: the Androsterone to Testosterone ratio (A/T), the
Androsterone to Etiocholanolone ratio (A/Etio), the 5α-Androstane-
3α,17β-diol to 5β-Androstane-3α,17β-diol ratio (5αAdiol/5βAdiol)

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 and the 5α-Androstane-3α,17β-diol to Epitestosterone ratio
(5αAdiol/E). For blood Samples, the Adaptive Model automatically
processes in
ADAMS one primary Marker, the Testosterone to Androstenedione
ratio (T/A4).

C.2.1.3.3 For the Endocrine Module, the Adaptive Model automatically

processes in ADAMS one primary Marker, the GH-2000 score
calculated using a formula including two (2) secondary Markers,
insulin-like growth factor-I (IGF-I) and N-terminal pro-peptide of type
III collagen (P-III-NP) measured in blood (serum) Samples.

C.2.1.4. Departure from WADA Athlete Biological Passport requirements

C.2.1.4.1 If there is a departure from WADA Athlete Biological Passport

requirements for Sample collection, transport and analysis, the
biological Marker result obtained from this Sample affected by the
non-conformity shall not be considered in the Adaptive Model
calculations (for example, RET% can be affected but not HGB
under certain transportation conditions).

C.2.1.4.2 A Marker result which is not affected by the non-conformity can still
be considered in the Adaptive Model calculations. In such case,
the Athlete Passport Management Unit shall provide the specific
explanations supporting the inclusion of the result(s). In all cases,
the Sample shall remain recorded in the Athlete’s Passport. The
Experts may include all results in their review provided that their
conclusions may be validly supported when taking into account the
effects of the non-conformity.

C.2.2 The Initial Expert Review

C.2.2.1 A Passport generating an Atypical Passport Finding, or for which a review is

otherwise justified, shall be sent by the Athlete Passport Management Unit to
an Expert for review in ADAMS. This should take place within seven (7) days
following the generation of the Atypical Passport Finding in ADAMS. The review
of the Passport shall be conducted based on the Passport and other basic
information (e.g. Competition schedules), which may be available, such that
the Expert is blinded to the identity of the Athlete. The Expert shall provide the
individual report in ADAMS and this should take place within seven (7) days
after receipt of the request.

C.2.2.2 If a Passport has been recently reviewed by an Expert and the Passport
Custodian is in the process of executing a specific multi-Sample Testing
strategy on the Athlete, the Athlete Passport Management Unit may delay the
review of a Passport generating an Atypical Passport Finding triggered by one
of the Samples collected in this context until completion of the planned series
of tests. In such situations, the Athlete Passport Management Unit shall clearly
indicate the reason for delaying the review of the Passport in the Athlete
Passport Management Unit Report.

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 C.2.2.3 If the first and unique result in a Passport is flagged as an Atypical Passport
Finding by the Adaptive Model, the Athlete Passport Management Unit may
recommend the collection of an additional Sample before initiating the initial
Expert review.

C.2.2.4 Review in the absence of an Atypical Passport Finding

C.2.2.4.1 A Passport may also be sent for Expert review in the absence of an
Atypical Passport Finding where the Passport includes other
elements otherwise justifying a review.

These elements may include, without limitation:

a) Data not considered in the Adaptive Model;

b) Any abnormal levels and/or variations of Marker(s);

c) Signs of hemodilution in the haematological Passport;

d) Marker levels below the corresponding Limit of Quantification of

the assay; or

e) Intelligence in relation to the Athlete concerned.

C.2.2.4.2 An Expert review initiated in the above-mentioned situations may

result in the same Consequences as an Expert review triggered by an
Atypical Passport Finding.

C.2.2.5 Expert Evaluation

C.2.2.5.1 When evaluating a Passport, an Expert weighs the likelihood that the
Passport is the result of the Use of a Prohibited Substance or
Prohibited Method against the likelihood that the Passport is the result
of a normal physiological or pathological condition in order to provide
one of the following opinions: “Normal”, “Suspicious”, “Likely doping”
or “Likely medical condition”. For a “Likely doping” opinion, the Expert
shall come to the conclusion that the likelihood that the Passport is
the result of the Use of a Prohibited Substance or Prohibited Method
outweighs the likelihood that the Passport is the result of a normal
physiological or pathological condition.

[Comment to Article C.2.2.5.1: When evaluating competing

propositions, the likelihood of each proposition is evaluated by the
Expert based on the evidence available for that proposition. It is
acknowledged that it is the relative likelihoods (i.e., likelihood ratio) of
the competing propositions that ultimately determine the Expert’s
opinion. For example, where the Expert is of the view that a Passport
is highly likely the result of the Use of a Prohibited Substance or
Prohibited Method, it is necessary for a “Likely doping” evaluation that
the Expert consider that it is unlikely that it may be the result of a

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 normal physiological or pathological condition. Similarly, where the
Expert is of the view that a Passport is likely the result of the Use of a
Prohibited Substance or Prohibited Method, it is necessary for a
“Likely doping” evaluation that the Expert consider that it is highly
unlikely that it may be the result of a normal physiological or
pathological condition.]

C.2.2.5.2 To reach a conclusion of “Likely doping” in the absence of an Atypical

Passport Finding, the Expert shall come to the opinion that it is highly
likely that the Passport is the result of the Use of a Prohibited
Substance or Prohibited Method and that it is highly unlikely that the
Passport is the result of a normal physiological or pathological
condition.

C.2.3 Consequences of the Initial Review

Depending on the outcome of the initial review, the Athlete Passport Management Unit will
take the following action:

Expert Evaluation Athlete Passport Management Unit Action

“Normal” Continue normal Testing plan.

Provide recommendations to the Passport Custodian

“Suspicious” for Target Testing, Sample analysis and/or requesting
further information as required.

Send to a panel of three (3) Experts, including the initial

“Likely doping”
Expert, as per section C.2 of this Annex C.

If recommended by the Expert, inform the Athlete as

“Likely medical condition” soon as possible via the Passport Custodian (or send to
other Experts).

[Comment to Article C.2.3: The Athlete Biological Passport is a tool to detect the possible
Use of Prohibited Substance(s) or Prohibited Method(s) and it is not intended as a health
check or for medical monitoring. It is important that the Passport Custodian educate the
Athletes to ensure that they undergo regular health monitoring and not rely on the Athlete
Biological Passport for this purpose. Nevertheless, the Passport Custodian should inform
the Athlete in case the Passport indicates a likely pathology as determined by the
Experts.]

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C.3 Review by Three (3) Experts

C.3.1 In the event that the opinion of the appointed Expert in the initial review, pending other
explanation to be provided at a later stage, is that of “Likely doping”, the Passport shall
then be sent by the Athlete Passport Management Unit to two (2) additional Experts for
review. This should take place within seven (7) days after the reporting of the initial review.
These additional reviews shall be conducted without knowledge of the initial review.
These three (3) Experts now constitute the Expert Panel, composed of the Expert
appointed in the initial review and these two (2) other Experts.
C.3.2 The review by the three (3) Experts must follow the same procedure, where applicable,
as presented in section C.2.2 of this Annex. The three (3) Experts shall each provide their
individual reports in ADAMS. This should take place within seven (7) days after receipt of
the request.
C.3.3 The Athlete Passport Management Unit is responsible for liaising with the Experts and for
advising the Passport Custodian of the subsequent Expert assessment. The Experts can
request further information, as they deem relevant for their review, notably information
related to medical conditions, Competition schedule and/or Sample(s) analysis results.
Such requests are directed via the Athlete Passport Management Unit to the Passport
Custodian.
C.3.4 A unanimous opinion among the three (3) Experts is necessary in order to proceed further
towards declaring an Adverse Passport Finding, which means that all three (3) Experts
render an opinion of “Likely doping”. The conclusion of the Experts must be reached with
the three (3) Experts assessing the Athlete’s Passport with the same data.
[Comment to Article C.3.4: The three (3) Expert opinions cannot be accumulated over
time based on different data.]
C.3.5 To reach a conclusion of “Likely doping” in the absence of an Atypical Passport Finding,
the Expert Panel shall come to the unanimous opinion that it is highly likely that the
Passport is the result of the Use of a Prohibited Substance or Method and that there is
no reasonably conceivable hypothesis under which the Passport is the result of a normal
physiological condition and highly unlikely that it is the result of pathological condition.
C.3.6 In the case when two (2) Experts evaluate the Passport as “Likely doping” and the third
Expert as “Suspicious”, the Athlete Passport Management Unit shall promptly confer with
the Expert Panel before they finalize their opinion. The group can also seek advice from
an appropriate outside Expert, although this must be done while maintaining strict
confidentiality of the Athlete’s Personal Information.
C.3.7 If no unanimity can be reached among the three (3) Experts, the Athlete Passport
Management Unit shall promptly report the Passport as “Suspicious”, update the Athlete
Passport Management Unit Report, and recommend that the Passport Custodian pursue
additional Testing and/or gather intelligence on the Athlete (refer to Information Gathering
and Intelligence Sharing Guidelines), as appropriate.

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C.4 Conference Call, Compilation of the Athlete Biological Passport Documentation Package
and Joint Expert Report

C.4.1 If a unanimous opinion of “Likely doping” is rendered by all three (3) Experts, the Athlete
Passport Management Unit shall promptly declare a “Unanimous likely doping” evaluation
in the Athlete Passport Management Unit Report in ADAMS and should organize a
conference call with the Expert Panel to initiate the next steps for the case, including
proceeding with the compilation of the Athlete Biological Passport Documentation
Package (see Technical Document for Athlete Passport Management Units) and drafting
of the joint Expert report. In preparation for this conference call, the Athlete Passport
Management Unit should coordinate with the Passport Custodian to compile any
potentially relevant information to share with the Experts (e.g. suspicious analytical
findings, relevant intelligence and relevant pathophysiological information).
C.4.2 Once completed, the Athlete Biological Passport Documentation Package shall be sent
by the Athlete Passport Management Unit to the Expert Panel, who will review it and
provide a joint Expert report to be signed by all three (3) Experts. The conclusion within
the joint Expert report shall be reached without interference from the Passport Custodian.
If necessary, the Expert Panel may request complementary information from the Athlete
Passport Management Unit.
C.4.3 At this stage, the identity of the Athlete is not mentioned but it is accepted that specific
information provided may allow to identify the Athlete. This shall not affect the validity of
the process.
C.4.4 If after review of the Athlete Biological Passport Documentation Package, the Expert
Panel is no longer unanimous in their opinion of “Likely doping”, the Expert Panel shall
update their respective opinions in ADAMS and the Athlete Passport Management Unit
shall update the Athlete Passport Management Unit Report accordingly.

C.5 Issuing an Adverse Passport Finding

C.5.1 If the Expert Panel confirms their unanimous position of “Likely doping”, the Athlete
Passport Management Unit shall promptly declare an Adverse Passport Finding in ADAMS
that includes a written statement of the Adverse Passport Finding, the Athlete Biological
Passport Documentation Package and the joint Expert report.
C.5.2 After reviewing the Athlete Biological Passport Documentation Package and joint Expert
report, the Passport Custodian shall:
a) Notify the Athlete of the Adverse Passport Finding in accordance with Article 5.3.2;

b) Provide the Athlete the Athlete Biological Passport Documentation Package and the
joint Expert report;

c) Invite the Athlete to provide their own explanation, in a timely manner, of the data
provided to the Passport Custodian.

C.6 Review of Explanation from Athlete and Disciplinary Proceedings

C.6.1 Upon receipt of any explanation and supporting information from the Athlete, which
should be received within the specified deadline, the Athlete Passport Management Unit
shall forward it to the Expert Panel for review with any additional information that the
Expert Panel considers necessary to render its opinion in coordination with both the

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 Passport Custodian and the Athlete Passport Management Unit, and update their
recommendation in ADAMS as “Athlete’s explanation provided to Expert panel”. At this
stage, the review is no longer anonymous. The Expert Panel shall promptly reassess or
reassert the case and reach one of the following conclusions:
a) Unanimous opinion of “Likely doping” by the Experts based on the information in the
Passport and any explanation provided by the Athlete; or
b) Based on the available information, the Experts are unable to reach a unanimous
opinion of “Likely doping” set forth above.
[Comment to Article C.6.1: Such a reassessment shall also take place when the Athlete
does not provide any explanation.]
C.6.2 If the Expert Panel expresses the opinion set forth in section C.6.1(a), then the Athlete
Passport Management Unit shall promptly update their recommendation in ADAMS as
“APF confirmed” and inform the Passport Custodian, who shall charge the Athlete in
accordance with Article 7 above and continue with Results Management in accordance
with this International Standard.
C.6.3 If the Expert Panel expresses the opinion set forth in section C.6.1(b), the Expert Panel
shall promptly update their respective opinions in ADAMS and the Athlete Passport
Management Unit shall update the Athlete Passport Management Unit Report,
accordingly, and recommend the Passport Custodian to pursue additional Testing and/or
gather intelligence on the Athlete (refer to Information Gathering and Intelligence Sharing
Guidelines), as appropriate. The Passport Custodian shall notify the Athlete and WADA of
the outcome of the review.

C.7 Passport Re-setting

C.7.1 In the event the Athlete has been found to have committed an anti-doping rule violation
based on the Passport, the Athlete’s Passport shall be reset by the Passport Custodian at
the start of the relevant period of Ineligibility and a new Biological Passport ID shall be
assigned in ADAMS. This maintains the Athlete’s anonymity for potential Athlete Passport
Management Unit and Expert Panel reviews conducted in the future.
C.7.2 When an Athlete is found to have committed an anti-doping rule violation on any basis other
than the Athlete Biological Passport, the Passport will remain in effect, except in those
cases where the Prohibited Substance or Prohibited Method may have altered Passport
Markers (e.g. for an AAF reported for anabolic androgenic steroids, which may affect the
Markers of the steroid profile, or for the Use of Agents Affecting Erythropoiesis or blood
transfusions, which would alter the haematological Markers). The Passport Custodian shall
consult with their Athlete Passport Management Unit following an Adverse Analytical
Finding to determine whether a Passport reset is warranted. In such instances, the Athlete’s
profile(s) would be reset from the time of the beginning of the sanction.

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 3.8. Athlete Passport Management Unit
Requirements and Procedures

WADA Technical Document – TD2023APMU

Document number: TD2023APMU Version number: 1.0
Written by: WADA Approved by: WADA Executive Committee
Date: November 2022 Effective date: 1 January 2023

1.0 Introduction
This Technical Document (TD) has been established to harmonize effective management of Athlete
Passports by providing specific requirements that an Athlete Passport Management Unit (APMU)
shall meet in order to be a WADA-approved APMU.

2.0 APMU Roles and Responsibilities

2.1 The APMU is the dedicated unit that is responsible for the timely management of Passports in
the Anti-Doping Administration and Management System (ADAMS) on behalf of the Passport
Custodian. Passport management by the APMU involves:
• Performing Passport assessments to make timely Target Testing recommendations to
the Passport Custodian via the APMU Report in ADAMS when appropriate; and
• Managing the review of atypical Passports according to Annex C of the International
Standard for Results Management (ISRM) [1], including, but not limited to, the following:
o Issuing and updating APMU Reports 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
(ABP) Documentation Package, and
o Declaring Adverse Passport Findings (APFs) to the Passport Custodian and WADA.
2.2 The APMU shall assess and manage Passport Sample validity in ADAMS, in consultation with
the Experts or Laboratories when necessary, per Article 8.2 of this TD.
2.3 The APMU shall provide 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 (TDP), and Target Testing.

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3.0 APMU Hosting
3.1 An APMU shall be hosted by a Laboratory.
[Comment: Hosting in this context is defined as the provision of facilities and resources for the efficient
functioning of the APMU.]

3.2 APMU hosting by a Laboratory does not preclude the use of qualified APMU managers employed
by ADOs or other Laboratories.
3.3 Passport management shall be carried out in ADAMS using dedicated APMU accounts
associated with the host Laboratory regardless of the physical location of the APMU manager(s).
3.4 The host Laboratory shall implement procedures to maintain the operational independence of the
APMU, including the appointment of dedicated personnel with a specified time commitment to
the APMU and a separate allocation in the budget so that the APMU can continue to function
should the WADA accreditation of the Laboratory be suspended (see Article 7.1.5 of this TD).

4.0 APMU Personnel

4.1 The host Laboratory shall have a Person qualified to function as the designated head of the
APMU by assuming professional, organizational, educational, and administrative responsibility of
the APMU. The APMU Director is responsible for ensuring the APMU operates in compliance
with this TD and applicable International Standards. In particular, the APMU Director assumes
the responsibility of signing and delivering all APFs to the Passport Custodian and WADA.
[Comment: The head of the APMU is termed “Director” herein, however use of this title is not a requirement
and can be adjusted according to the needs of the organization.]

4.1.1 The APMU Director’s qualifications shall ensure that this individual is competent and capable
of leading the APMU operations, including:
• A doctoral degree (or equivalent) in one of the natural sciences or medicine, or in the
absence of a doctoral degree, a master’s degree (or equivalent) with extensive and
appropriate anti-doping science experience and training (i.e., minimum of five (5) years);
• Management experience;

• Ability to oversee compliance with quality management practices; and

• Good command of at least one of WADA’s two official languages, English and French.

It is acknowledged that the APMU Director plays an essential role in the APMU
operations and that WADA APMU approval is delivered based upon appointment of a
proper candidate. WADA reserves the right to review the credentials of such
appointment in accordance with the above qualifications.

4.1.2 The APMU Director is responsible for maintaining documentation for each personnel employed
by, or under contract to, the APMU. Such documentation shall contain copies of the curriculum

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 vitae or qualification form, a job description, and records of initial and ongoing training related
to anti-doping.

4.1.3 Any personnel changes to the position of APMU Director shall be communicated to WADA no
later than one (1) month prior to the date the APMU Director is scheduled to vacate the
position. A succession plan shall be submitted to WADA.

4.1.4 The APMU Director is notably responsible for monitoring the quality of Passport management
and ensuring that other APMU personnel have the experience and training necessary to
perform their duties.

4.2 The APMU shall use qualified scientific personnel to serve as APMU manager(s) to manage the
Passport review process and Sample validity, and to provide Target Testing and Analytical
Testing recommendations through APMU Reports in ADAMS. APMU manager(s) shall be
employed by the host Laboratory or be under contract by an ADO or another Laboratory. The
APMU should have at least one APMU manager per module of the ABP, where one manager
may supervise multiple modules based on their qualifications.
[Comment: The designation of “manager” is used herein, however use of this title is not a requirement and
can be adjusted according to the needs of the organization. The APMU Director can also serve in the role
of APMU manager as required. Where the APMU manager is employed by an ADO, it is assumed that this
individual will have access to the identity and other privileged or confidential information about the Athlete,
past Testing and/or Results Management and investigations history. This additional information shall not
be shared by the APMU manager in the APMU Report but is recognized to be important to contribute to
effective Target Testing.]

4.2.1 APMU manager(s) shall have qualifications in one or more modules of the ABP. The
qualifications are at minimum:
• Bachelor’s degree (or equivalent) in one of the natural or health sciences. Documented
experience of three (3) years or more in anti-doping or similar scientific training is
equivalent to a Bachelor’s degree for this position; and
• Adequate training in one or more modules of the ABP, capacity to understand and
evaluate analytical results and the physiological response to the Use of Prohibited
Substances and Prohibited Methods, as well as criteria relevant for Target Testing.

4.2.2 Where the APMU manager has strong qualifications in Laboratory steroid analysis, steroid
doping and metabolism and/or clinical endocrinology, and is not employed by the Passport
Custodian, the APMU manager can act as a first Expert for the Steroidal Module of the ABP.

4.3 The APMU should have administrative personnel to coordinate with the Passport Custodian to
compile the necessary documentation required for the ABP Documentation Packages, manage
communication with various stakeholders and assist with the organization of APMU-related
documentation.

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5.0 APMU Confidentiality and Security
5.1 All APMU related activities shall be carried out in accordance with the confidentiality requirements
of the Code and International Standards.

5.2 While APMU activities are typically carried out using Passport data associated with a unique ID,
and while APMU staff generally do not have access to data that would enable them to identify
Athletes in ADAMS, APMUs may access Personal Information where additional information is
needed to assess a Passport (e.g., when assessing a Passport that has generated an ATPF). In
such contexts, Personal Information shall only be processed for the purposes set out in this TD,
and shall be handled by the APMU in accordance with the International Standard for the
Protection of Privacy and Personal Information (ISPPPI) [2] and applicable laws.

5.3 Without limiting the above, the APMU shall adhere to those information retention times set forth
in Annex A of the ISPPPI. In consultation with the Passport Custodian, the APMU shall develop
specific plans and procedures to ensure the secure retention and eventual destruction of
Personal Information.

5.4 The APMU shall develop, maintain, implement and ensure ongoing compliance with a written
information security program that includes physical, organizational, technical, environmental and
operational safeguards appropriate to the sensitivity of the information in its custody or to which
it has access. Such program shall be based on a threat and risk assessment by expert(s) in the
relevant field, and shall ensure the confidentiality of its procedures and security of its information
systems regardless of the physical location of the APMU personnel at the time of Passport
management, such as when the APMU manager is physically located in an ADO, another
Laboratory or when travelling.

6.0 ABP Expert Panel

6.1 The APMU shall engage the services of qualified Experts for the review of Passports in
accordance with Annex C of the ISRM [1]

6.2 The APMU should inform WADA about any changes in their pool of Experts.

6.3 The APMU shall establish, in consultation with the Passport Custodian, a list of Experts who are
qualified to comprise an Expert panel for the review of Passports.
• For the Hematological Module, the Expert panel should consist of at least three (3)
Experts who have qualifications in one or more of the fields of clinical and laboratory
hematology, sports medicine and exercise physiology, as they apply to blood doping.
• For the Steroidal Module, the Expert panel should be composed of at least three (3)
Experts with qualifications in the fields of Laboratory steroid analysis, steroid doping,
and/or clinical endocrinology, as it applies to steroid Marker metabolism.

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 • For the Endocrine Module, the Expert panel should be composed of at least three (3)
Experts with qualifications in the fields of endocrine biomarker analysis, doping with
growth hormone and related compounds, and/or clinical endocrinology, as it applies to
growth hormone Marker metabolism.
For each module, an Expert panel should consist of Experts with complementary knowledge such
that all relevant fields are represented.
All three (3) Experts forming an Expert panel assigned to review a particular Passport shall not
be of one and the same nationality and no two (2) Experts shall have a primary affiliation with the
same organization, institution or company, including, but not limited to, universities, hospitals and
research institutes.
Where applicable, at least one Expert on the Expert panel should currently serve or have
previously served as an Expert and reviewed Passports for a WADA-approved APMU.

6.4 The APMU shall ensure that each Expert:

• Has access to relevant ABP Expert education resources provided by WADA;

• Has an Expert account in ADAMS for the anonymous review of Passports assigned by
the APMU;
• Is independent of the Passport Custodian and has no conflicts of interest in reviewing
Passports, as documented in a conflict-of-interest declaration; and
• Has signed the WADA ABP Expert Code of Conduct Declaration.
[Comment: An APMU manager may also concurrently serve as an Expert for other APMUs,
provided all requirements of Article 6.0 of this TD are met.]

7.0 Process and Requirements for WADA APMU Approval

Passports shall only be managed by APMUs that have been approved by WADA.Applying for WADA
APMU Approval

7.1.1 Expression of Interest

The candidate APMU shall officially contact WADA in writing to express its interest in the
WADA APMU approval process.

7.1.2 Preliminary Discussion with WADA

The purpose of this discussion is to clarify issues with regard to the approval process and to
obtain information about different aspects of the APMU relevant to the approval process. Such
a discussion could be conducted prior to or during the approval process.

7.1.3 Description of the Candidate APMU

The candidate APMU shall then complete a detailed application form provided by WADA and
submit it to WADA no later than eight (8) weeks following receipt. The application form
includes, but is not limited to, the following:

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 • List of staff, their qualifications and intended role within the APMU;

• Description of the APMU information security program (see Article 5.4 of this TD),
including a description of the physical, organizational, technical, environmental and
operational security measures implemented to protect records and computer systems;
• List of external Experts, their contact information, their qualifications and signed ABP
Expert Code of Conduct Declaration;
• Business Plan for the APMU and letters of support from ADOs that demonstrate a
commitment to manage, according to Article 2.0 of this TD, a minimum of 100 active
hematological Passports and 500 active steroidal Passports from Signatories annually,
within one year of receiving approval. An eligible Business Plan shall demonstrate a
commitment to provide at least 200 APMU Reports for hematological Passports and 500
APMU Reports for steroidal Passports per year.
[Comment: A Passport is considered active when at least one Sample collection is planned during
the first year of operation of the APMU. There is no minimum number of active endocrine
Passports required for the business plan.]

7.1.4 Liability Insurance Coverage

The APMU shall provide documentation to WADA that professional liability risk insurance
coverage or equivalent has been obtained which covers the APMU to an amount of no less
than (≥) 2 million USD annually, and should ensure that the Expert panel has suitable
professional liability risk insurance or equivalent coverage.

7.1.5 Operational Independence

The APMU shall ensure a degree of operational independence from the host Laboratory such
that the APMU can continue to fulfil its responsibilities in compliance with this TD should the
WADA accreditation of the Laboratory be suspended, where the reason for the Suspension
does not have an impact on the function of the APMU. Operational independence implies that
the APMU shall have a separate allocation in the budget and sufficient technical and human
resources to permit the APMU to manage its own affairs without hindrance or interference by
host Laboratories.

7.1.6 Compliance with the WADA APMU Code of Ethics

The candidate APMU shall implement and comply with the provisions in the WADA APMU
Code of Ethics. The APMU shall provide the APMU Code of Ethics to APMU personnel and
ensure their understanding and compliance with all aspects. The candidate APMU shall
provide to WADA a letter of compliance with the APMU Code of Ethics, signed by the APMU
director.

7.1.7 WADA Recommendation for Approval

After receipt of the application form, WADA will complete and submit a report to the candidate
APMU. The report will include a recommendation concerning approval of the candidate APMU.
In the case where the recommendation is that the APMU should not be approved, the report

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 will identify improvements required in order to be re-considered for designation as a WADA-
approved APMU. In the case where the recommendation is that the APMU should be
approved, the report and recommendation will be submitted to the WADA Executive
Committee for approval.

7.1.8 Issuing Approval Letter and Publishing APMU List on WADA’s Website
A letter signed by a duly authorized representative of WADA shall be issued in recognition of
approval of an APMU, specifying the name of the APMU Approval may be granted with
retroactive effect. An updated list of approved APMUs shall be published by WADA on
WADA’s website.

7.2 Maintaining WADA Approval

An APMU shall continue to function if the Laboratory’s accreditation is suspended, provided that
the APMU continues to meet other criteria for approval, and that any non-conformities related to
the Suspension of the Laboratory’s accreditation do not have an impact on the APMU. The
APMU’s approval shall be revoked if the WADA accreditation of the associated Laboratory is
revoked.
[Comment: Suspension or Revocation of APMU approval shall not be considered in decisions on
Suspension or Revocation of Laboratory accreditation unless the APMU non-compliance has a clear
impact on the function of the Laboratory.]

7.2.1 Minimum Number of Passports and APMU Reports

In order to maintain proficiency, WADA-approved APMUs are required to review a minimum
number of Passports and provide APMU Reports for Passports of Signatory Passport
Custodians. WADA shall monitor the total number of Passports under the responsibility of the
APMU and the number of APMU Reports issued by the APMU. If the annual number falls
below 100 active hematological Passports, 500 active steroidal Passports, 200 hematological
APMU Reports or 500 steroidal APMU Reports, WADA APMU approval may be suspended
or revoked.
[Comment: For the purposes of WADA APMU monitoring, a Passport is considered active when at least
one Sample is collected during the previous twelve months period at the time of the assessment. There
is no minimum number of active endocrine Passports or APMU Reports required to maintain APMU
approval.]

7.2.2 Documenting Compliance with the WADA APMU Code of Ethics

The APMU shall annually provide to WADA a letter of compliance with the provisions of the
APMU Code of Ethics, signed by the APMU Director. All APMU personnel shall sign the WADA
APMU Code of Ethics on a yearly basis and the signed documents shall be kept as part of
their personnel file. The APMU may be asked to provide documentation demonstrating
compliance with the provisions of the APMU Code of Ethics.

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 7.2.3 Documenting Sharing of Knowledge
The APMU shall proactively share knowledge with other WADA-approved APMUs. The APMU
should participate at least once annually in a WADA Working Group or an anti-doping
symposium or conference. The APMU shall supply an annual report on sharing of knowledge
with WADA. A description of this sharing of knowledge is provided in the WADA APMU Code
of Ethics.

7.2.4 Maintaining Professional Liability Insurance Coverage

The APMU shall maintain an ongoing professional liability risk insurance coverage or
equivalent which covers the APMU to an amount of no less than (≥) 2 million USD annually,
and should ensure that the Expert panel has suitable professional liability risk insurance or
equivalent coverage. Proof of the corresponding coverage shall be provided to WADA upon
request.

7.2.5 APMU Compliance Monitoring by WADA

WADA shall monitor the compliance of APMUs against the requirements listed in applicable
International Standards and TDs. In addition, WADA shall also conduct periodic audits of
APMU compliance to assess the overall performance of each APMU and to decide its approval
status.

7.2.6 APMU Assessment by WADA

WADA reserves the right to conduct document-based audits as well as inspect and assess
the APMU through on-site or remote assessments at any time, at WADA’s expense. The notice
of an on-site assessment will be made in writing to the APMU Director. In exceptional
circumstances, the on-site assessment may be unannounced.

7.2.7 Suspension or Revocation of Approval

Suspension or Revocation of APMU approval may occur whenever the APMU fails to comply
with applicable International Standards and/or TDs, or where such measure is otherwise
required in order to protect the interests of the anti-doping community.
Without limitation, the following nonconformities in the routine operations of an APMU may be
considered in support of Suspension:
• Failure to comply with any of the requirements listed in applicable International
Standards and/or TDs;
• Failure to cooperate with WADA or the relevant Testing Authority in providing
documentation;
• Noncompliance(s) with the APMU Code of Ethics;

• Major changes in key staff without proper and timely notification to WADA;

• Failure to cooperate in any WADA inquiry in relation to the activities of the APMU;

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 • Noncompliance(s) identified from APMU assessment(s); or

• Loss of resources jeopardizing the quality and/or viability of the APMU.

Noncompliance(s) in APMU performance will be assessed by WADA on a case-by-case basis

considering the severity and consequences to the anti-doping system. Evidence of serious or
multiple noncompliance(s) will be reported by WADA to an external assessment panel, who
will make a recommendation to WADA regarding the approval status of the APMU and the
required corrective actions and associated deadlines. WADA reserves the right to provisionally
suspend an APMU’s approval pending a full investigation. Such a decision may be taken by
the Chair of WADA’s Executive Committee.
The period and terms of Suspension shall be proportionate to the seriousness of the
noncompliance(s) and the need to ensure reliable management of Athlete Passports. A period
of Suspension shall be of a duration to be decided by WADA and up to a maximum of six (6)
months, during which time any nonconformity(ies) must be corrected and such correction
documented and reported to WADA. If the nonconformity(ies) is/are not corrected during the
initial Suspension period, the Suspension shall either be further extended or the APMU
approval revoked. The Suspension period may be extended up to a maximum of an additional
six (6) months, based on justifiable delays in implementing the satisfactory corrective actions.
If the APMU has provided evidence determined to be satisfactory by WADA that the
noncompliance(s) are corrected, the APMU’s approval shall be re-instated. If the APMU has
not provided evidence determined to be satisfactory by WADA at the end of the extended
Suspension period, not to exceed twelve (12) months, the APMU’s approval shall be revoked.
During the period of Suspension of the APMU, the management of all Athlete Passports shall
be transferred by the Passport Custodian to another WADA-approved APMU after signing an
agreement with this other APMU.
The WADA Executive Committee shall revoke the approval of any APMU if it determines that
Revocation is necessary to ensure reliable management of Athlete Passports. Revocation
may be based on, but not limited to, the following noncompliance(s) in the routine operations
of an APMU:
• Repeated suspensions of WADA APMU approval;

• Systematic failure to comply with applicable International Standards and/or TDs;

• Failure to correct a lack of compliance with any of the requirements listed in applicable
International Standards and/or TDs during a Suspension period;
• A serious or repeated violation of the APMU Code of Ethics;

• Repeated and/or continuous failure to cooperate in any WADA inquiry in relation to the
activities of the APMU;
• Serious noncompliance(s) identified from APMU assessment(s); or

• Loss of resources jeopardizing the quality and/or viability of the APMU.

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 7.2.8 Appeals
WADA’s decision to suspend or revoke an APMU’s approval may be appealed in writing by
the APMU before CAS within twenty-one (21) days of the date of receipt of notification.

8.0 Passport Management and Administration

The APMU shall manage all Passports under the custody of the Passport Custodian.

8.1 Passport Review Process

The APMU shall carry out the Passport review process as described in Annex C of the ISRM [1].

8.1.1 When assessing a newly matched Sample in a Passport:

• The APMU shall assess the validity of individual Samples contained within the Passport
in ADAMS and address any observed irregularities according to Article 8.2 of this TD by
updating the APMU Report;
• The APMU shall review any new Samples within the updated Passport and provide
Target Testing, Sample analysis or other recommendations via the APMU Report as
required;
• Where required for its analysis, the APMU may request further information from the
Passport Custodian including, but not limited to, circumstances and details of Sample
collection, transport, and analysis, redacted Athlete Competition schedule, travel history,
Athlete performance, redacted Athlete medical information, information on an Adverse
Analytical Finding (AAF) that is potentially relevant in the context of the Passport, or
altitude/whereabouts information which may help them interpret the new Sample;
• Where the Passport includes elements justifying a review or upon request by the
Passport Custodian, the APMU shall send the Passport for review in ADAMS by an
Expert.
[Comment: One of the benefits of the ABP is the ability to focus resources on atypical results
requiring attention. As such, it is not mandatory for an APMU to review all newly matched
Samples under their responsibility that do not generate a specific notification requiring mandatory
follow-up. Nevertheless, at the discretion of the Passport Custodian, an APMU may be requested
to review normal Passports.]

8.1.2 When assessing a Passport that generated an ATPF:

• All ATPFs shall be reviewed by a Laboratory-based APMU manager;
[Comment: ATPFs are generated by the following primary Markers: hemoglobin (HGB) and the
OFF-Score for the Hematological Module; the testosterone to epitestosterone ratio (T/E) in urine,
and testosterone (T) and/or the testosterone to androstenedione ratio (T/A4) in blood for the
Steroidal Module; and the GH-2000 score for the Endocrine Module.]

• The APMU shall review any previous APMU Reports associated with the Passport;

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 • The APMU shall assess the validity of individual Samples contained within the Passport
in ADAMS, address any irregularities according to Article 8.2 of this TD and update the
APMU Report accordingly;
• The APMU shall evaluate the need for urgent Target Testing of the Athlete and
communicate Testing recommendations to the Passport Custodian via the APMU Report
as required;
• The APMU shall assess the need for additional analysis of existing Samples by specific
methods (e.g., Agents Affecting Erythropoiesis, Gas Chromatography / Combustion /
Isotope Ratio Mass Spectrometry [GC/C/IRMS], Steroid Esters, hGH Isoform Differential
Immunoassay, etc.) and communicate these to the Passport Custodian via the APMU
Report as required. The APMU may also recommend specific Sample(s) to be placed in
long-term storage.
• If an Expert has previously recommended that follow-up Testing include a minimum
number of Samples before further review of an Athlete’s Passport data, the APMU may
delay sending the Passport for Expert review until the planned number of Samples have
been collected and analyzed;
• If, after managing the Sample validity, the Passport remains atypical, the APMU shall,
without delay, send the Passport for review in ADAMS by an Expert according to Article
C.2.2 of the ISRM [1]. In the event of an Expert opinion of:
o “Likely Doping”: the APMU shall update the APMU Report indicating “Likely Doping”,
specifying any detailed analysis or Testing recommendations from the Expert (if
provided), and continue the Passport review process according to Article C.3 of the
ISRM [1];
o “Suspicious”: the APMU shall update the APMU Report indicating “Suspicious”,
highlighting the main atypical features, and outline a Target Testing strategy (if
necessary) based on the Expert recommendations, or recommend further analysis
(e.g., GC/C/IRMS);
o “Normal”: the APMU shall update the APMU Report indicating “Normal”, summarizing
the review by the Expert and outlining any Testing recommendations provided by the
Expert;
o “Likely Medical Condition”: the APMU shall update the APMU Report indicating
“Likely Medical Condition” with submission to additional Experts if recommended in
the Expert evaluation and should inform the Athlete via the Passport Custodian. If the
first Expert is not a medical doctor, the Passport should be sent to a medical doctor
from the Expert panel prior to contacting the Passport Custodian.
[Comment: the APMU recommendation in ADAMS should mirror the Expert’s opinion(s) and
any changes in the status of the APMU recommendation should be based on a change in
Expert opinion(s) upon further review of the Passport.]

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 8.1.3 When assessing a urine Sample that generated an Atypical Passport Finding - Confirmation
Procedure Request (ATPF-CPR; see TD EAAS [3]) for the steroidal Passport:
• The APMU shall assess the validity of the Sample generating the Confirmation
Procedure (CP) request in ADAMS, address any irregularities according to Article 8.2 of
this TD and update the APMU Report accordingly;
• When the ATPF-CPR has been triggered for a Sample where the presence of ethanol
or other factors impacting the steroid profile have been reported, the APMU shall
evaluate the need to perform CP(s) and update the APMU Report accordingly within
seven (7) days. Justification not to proceed with CP(s) may include:
o the presence of ethanol glucuronide (EtG) in a Sample from an Athlete with previous
similar findings in their Passport with negative GC/C/IRMS results (indicating a
pattern of alcohol abuse); or
o communication of the existence of other AAFs reported for the Sample to the APMU
by the Passport Custodian or Testing Authority, as applicable, which would likely lead
to a maximum sanction; or
o communication of the existence of a Therapeutic Use Exemption (TUE) for the Athlete
to the APMU by the Passport Custodian or Testing Authority, as applicable.
[Comment: As stated in the TD EAAS, in such cases, the Passport Custodian, or Testing
Authority as applicable, shall advise the Laboratory, in writing and within fifteen (15) days
following reception of the ATPF-CPR notification, whether or not to proceed with CP(s) of the
Sample’s steroid profile.]

• In cases when an ATPF-CPR is generated for two (2) or more Samples, which are linked
to a single Sample Collection Session from the same Athlete, the APMU should advise
the Passport Custodian, and Testing Authority as applicable, to prioritize the
confirmation of the Sample with the highest concentration of Markers of the steroid
profile. In such cases, the Passport Custodian, or Testing Authority as applicable, shall
advise the Laboratory, in writing and within fifteen (15) days following reception of the
ATPF-CPR notification, whether or not to proceed with CP(s) of the Sample’s steroid
profile.

8.1.4 When assessing a Suspicious Steroid Profile Confirmation Procedure Request (SSP-CPR):
The APMU will receive an SSP-CPR notification through ADAMS when there is no existing
urine steroidal Passport for the Athlete in ADAMS (i.e. this is the first Sample in the Athlete’s
steroidal Passport), and the Sample’s “steroid profile” meets any of the following criteria:
a) T/E ratio > 4.0;
b) Concentration of T or E (adjusted for the SG) > 200 ng/mL in males or > 50 ng/mL in
females;
c) Concentration of A or Etio (adjusted for the SG) > 10,000 ng/mL;

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 d) Concentration of 5αAdiol (adjusted for the SG) > 250 ng/mL in males or > 150 ng/mL in
females.
Upon receipt of an SSP-CPR notification:
• The APMU shall assess the validity of the Sample generating the CP request in ADAMS,
address any irregularities according to Article 8.2 of this TD and update the APMU
Report accordingly.
• The APMU shall evaluate the need to perform CP(s) and update the APMU Report
accordingly within seven (7) days of receipt of the SSP-CPR notification. The Passport
Custodian, or Testing Authority as applicable, shall advise the Laboratory, in writing and
within fifteen (15) days following reception of the SSP-CPR notification, whether the
Laboratory shall proceed with CP(s).
[Comment: In the absence of an ATPF-CPR or SSP-CPR, the APMU may also make a
recommendation for CPs of the steroid profile, based on assessment by the APMU.]

8.1.5 Expert Review of Normal Passports

The APMU should provide the Experts from time to time with Passports for review, even when
the values are within normal ranges and presenting no suspicious elements, as this will ensure
that Experts are provided a balanced perspective on the Athletes’ Passports.

8.2 Management of Sample Validity

8.2.1 The APMU shall assess and manage the validity of urine, blood (serum) and blood ABP (whole
blood) Samples in ADAMS according to applicable International Standards and TDs, including
the ISRM [1], TD EAAS [3] International Standard for Laboratories (ISL) [4], and the International
Standard for Testing and Investigations (ISTI) [5].

8.2.2 Any changes in Sample validity made by the APMU shall be noted in applicable fields in
ADAMS and in the APMU Report.

8.2.3 Where multiple Samples were provided by an Athlete during a single Sample Collection
Session and are present in a Passport, the APMU shall invalidate all but one Sample based
on assessment by the APMU.

8.2.4 Where multiple Samples were provided by an Athlete on the same day from different Sample
Collection Sessions and are present in a Passport, the APMU may invalidate all but one
Sample after assessment by the APMU in consultation with the Passport Custodian, as
required

8.2.5 For urine Samples where a substance(s) that may alter the steroid profile is detected by the
Laboratory (e.g., alcohol), the APMU may invalidate the Sample when it is considered to affect
the sensitivity of the Adaptive Model to detect changes in future Samples.

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 8.2.6 For blood ABP Samples of suspicious profiles where the Blood Stability Score (BSS) could not
be calculated, the APMU shall assess the collection-to-analysis time (CAT), any available
temperature logger data, and the potential degradation of blood Markers, including
scattergrams, in order to evaluate Sample validity, liaising with (an) Expert(s) as required.

8.3 The APMU Report

The APMU Report is a central element in the administrative sequence of the ABP that shall be
entered and maintained by the APMU in ADAMS. The APMU Report provides an up-to-date
overview of the current status of an Athlete’s Passport together with recommendations, as
appropriate, for efficient follow-up by the Passport Custodian. The APMU Report serves to update
the Passport Custodian, WADA and other ADOs with whom the Passport is shared. In addition,
it provides a record of events associated with a Passport in ADAMS.
The APMU Report may include, without limitations:
• Assessments of Sample validity by the APMU and/or Experts;
• Recommendations for complementary Analytical Testing (e.g., Agents Affecting
Erythropoiesis, HIF stabilizers, Homologous Blood Transfusion, confirmation of steroid
profile, GC/C/IRMS, long-term steroid Metabolites, IGF-I analogs, Steroid Esters, hGH
Isoform Differential Immunoassay etc.) on Samples collected;
• Recommendations for further Analytical Testing on Samples collected previously;
• Recommendations for long-term storage of Samples for Further Analysis;
• Target Testing recommendations based on available data and Experts’
recommendations; and
• A summary of any recent Expert reviews.

8.3.1 APMU Reports shall be written in English and should not contain any information that could
identify the Athlete.

8.3.2 The APMU Report shall not contain any reference to an AAF that may be known to the APMU,
with the exception of when the AAF is used by the APMU as a reason not to perform CP(s)
following an ATPF-CPR or SSP-CPR for the steroid profile (see Articles 8.1.3 and 8.1.4 of this
TD). If the APMU assessment leads to an Expert review, the APMU may, however, separately
inform the Expert(s) of the existence of the AAF. Depending on the result of the Expert review,
the APMU shall further inform the Results Management Authority managing the AAF of the
result of the Expert review, via the Passport Custodian, if that information is potentially relevant
in the context of the Results Management based on the AAF.
[Comment: While Passport sharing is strongly encouraged to enhance ADO efficiencies and program
effectiveness through exchange of information and mutual recognition of program outcomes, this must
be carried out within the framework of the ISPPPI [2] and Article 14.1.4 of the Code [6]. The information
regarding an AAF shall therefore not be recorded in the APMU Report and shall not be disclosed
unnecessarily. Only those individuals and/or organizations involved in the applicable Results
Management process should be privy to this information.]

8.3.3 Target Testing recommendations shall be included in the APMU Report with a sufficient level
of detail for the Passport Custodian to conduct effective, timely and appropriate Testing.

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8.4 Investigating Urine Exchange
When a urine Sample steroid profile is not consistent with other Sample(s) from the Athlete’s
Passport, urine exchange with the urine of another individual may be suspected and confirmed
using DNA analysis across multiple Samples. This process is managed and reported according
to the following steps:
• When evaluating a newly matched urine Sample, where other Samples exist in the
Athlete’s Passport, the APMU shall evaluate the likelihood that all Samples are from the
same individual. If a Sample shows inconsistency compared to others in the Passport
(e.g. differences in Marker levels), the APMU shall update the APMU Report indicating
“Suspicion of Urine Exchange”;
• If the APMU suspects urine exchange, an investigation shall be launched by the
Passport Custodian, with support from the APMU, using a combination of actions such
as Sample storage, confirmation of the steroid profiles of relevant Samples, collection of
additional Samples, and/or DNA analysis, as applicable.

8.4.1 The outcomes of this investigation may indicate:

a) Confirmation by DNA analysis that all Samples belong to the same Athlete. In this case,
the APMU shall update the APMU Report accordingly.
b) Multiple DNA profiles are present: where at least two (2) different DNA profiles are identified
across different Samples, where each urine Sample corresponds to a single DNA profile,
however the DNA profile corresponding to the Athlete under investigation is not known. A
strategy shall be undertaken in order to obtain additional Samples and the APMU shall
update the APMU Report accordingly indicating “Multiple DNA Profiles Identified”.
c) Confirmed urine exchange: where at least two (2) different DNA profiles have been
identified, where each urine Sample corresponds to a single DNA profile, and the DNA
profile belonging to the Athlete is confirmed with a reasonable degree of certainty (e.g.
using multiple Samples, different Sample types, different Sample Collection Personnel). In
such cases, the APMU shall update the APMU Report, indicating “Urine Exchange
Confirmed”.
d) Mixed Samples: where multiple DNA profiles are found within individual Samples. In such
cases, the APMU shall liaise with the Passport Custodian, or Testing Authority as
applicable, regarding the Sample in question to explore whether the Laboratory should
consider further investigations towards declaring an AAF for Sample Tampering or
Attempted Tampering.
[Comment: Where Tampering or Attempted Tampering of a Sample can be established by the
analyzing Laboratory based on evidence from that Sample alone (e.g., substitution with another fluid,
mixing of urines, addition of proteases to the Sample), the Laboratory can report the finding as an
AAF or Atypical Finding for Tampering or Attempted Tampering (see Article 4.0 of the TD EAAS [3]).
In contrast, when urine exchange can be established based on steroid profile and/or DNA evidence
across multiple Samples, the APMU shall report the finding of confirmed urine exchange to the
Passport Custodian, who shall proceed with Results Management according to Code Article 2.2 [6]]

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8.5 Analysis of Steroid Esters
When blood Samples demonstrate atypical or suspicious steroid Markers, or have been collected
during the same Sample Collection Session as urine Samples identified with an atypical or
suspicious “steroid profile”, the APMU, in consultation with the Passport Custodian, should
consider requesting analysis to detect the presence of Steroid Ester(s) in the associated blood
Samples.
The detection of Steroid Ester(s) in blood also constitutes an unequivocal demonstration of the
exogenous origin of the steroid(s). On the other hand, the absence of detectable Steroid Ester(s)
in blood shall not invalidate an AAF based on the GC/C/IRMS analysis in urine.

8.6 Compiling the ABP Documentation Package

8.6.1 The APMU shall be responsible for compiling the ABP Documentation Package using the
template provided by WADA. The Passport Custodian shall collect information and bear the
cost of compiling ABP Documentation Packages unless it has established an agreement to
share the costs with relevant Testing Authorities.

8.6.2 Upon request by the APMU and as needed to compile the ABP Documentation Package, the
Passport Custodian shall provide a detailed Athlete Competition and altitude schedule,
relevant information from DCFs, temperature logger and Chain of Custody documentation to
the APMU.

8.6.3 The APMU shall confer with the Expert panel to determine the scope of such compilation,
including the recommended elements and the number of tests that need to be included. It is
only mandatory to have a full ABP Laboratory Documentation Package for those Samples that
are deemed essential by the Expert panel (see TD LDOC [7]). Other relevant Samples, for
example those that confirm the baseline levels of a Marker, only require an ABP Laboratory
Certificate of Analysis (see TD LDOC [7]). If the Passport Custodian is not the Testing Authority
of the test requiring Laboratory documentation, the Passport Custodian shall coordinate with
the Testing Authority to obtain such documentation.
[Comment: Where a Laboratory Documentation Package for specific analysis (GC/C/IRMS, ERA or
hGH) is requested during the compilation of an ABP Documentation Package, a request should be
addressed to the Laboratory as per specific Annexes of the TD LDOC.]

8.6.4 The following key information shall be included in an ABP Documentation Package regardless
of the module (Hematological, Steroidal, or Endocrine):
• For the Athlete: age (excluding the date of birth), gender, and sport/discipline;
• For all Samples: date and time of collection, ADAMS ordinal number in the Passport,
Sample code, Marker values and graphical results obtained by the Adaptive Model;
• For Samples selected by the APMU and Expert panel:
o ABP Laboratory Documentation Package(s) and/or ABP Certificate(s) of Analysis
from the relevant Laboratory(-ies) and/or ABP Laboratory(-ies) (see TD LDOC [7]);
and

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 o The Passport Custodian shall provide Chain of Custody documentation, DCF
information and a detailed Competition calendar covering the period defined by the
selected Samples; and
For the Hematological Module, the following additional information shall be provided for the
Samples selected by the APMU and Expert panel:
• Temperature profile during the transportation of the blood ABP Sample and, when
available, the BSS; and
• Responses provided by the Athlete on the ABP Supplementary Report Form during the
Sample Collection Session.
For the Steroidal Module, the following additional information shall be provided for the
Samples selected by the APMU and Expert panel:

• Urine Samples

o pH;
o Specific gravity (SG);
o Laboratory documentation, including screening and confirmed values (where
applicable) of steroid concentrations and ratios (see TD LDOC [7] and TD EAAS [3]);
o GC/C/IRMS results, where applicable;
o Indication of ethanol consumption: urinary concentrations of ethanol and/or ethanol
Metabolite(s);
o Indication of microbial growth (see TD EAAS [3]); and
o Information on the presence or absence of substances that may alter the steroid
profile (see TD EAAS [3]).
• Blood Samples

o Laboratory documentation, including screening and confirmed concentrations

(where applicable) of steroid Markers (see TD LDOC [7]);
For the Endocrine Module, the following additional information shall be provided for the
tests selected by the APMU and Expert panel:

• Laboratory documentation, including screening and confirmed concentrations (where

applicable) of Markers of the Endocrine Module (see TD LDOC [7]);

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9.0 References
[1] The World Anti-Doping Code International Standard for Results Management.
[2] The World Anti-Doping Code International Standard for the Protection of Privacy and Personal Information.
[3] WADA Technical Document TD EAAS: Measurement and Reporting of Endogenous Anabolic Androgenic
Steroid (EAAS) Markers of the Urinary Steroid Profile.
[4] The World Anti-Doping Code International Standard for Laboratories.
[5] The World Anti-Doping Code International Standard for Testing and Investigations.
[6] The World Anti-Doping Code.
[7] WADA Technical Document TD LDOC: Laboratory Documentation Packages.

[Comment: Current versions of WADA ISL and Technical Documents may be found at https://www.wada-
ama.org/en/anti-doping-partners/laboratories]

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Part 4: Collaboration Agreement
Template
A non-mandatory collaboration agreement template is contained herein to facilitate the exchange of
relevant information and mutual recognition of ABP program outcomes between ADOs that share
Testing jurisdiction over a single Athlete (e.g., National Anti-Doping Organization and International
Federation). Anti-Doping Organizations will need to review and modify this template as necessary to
ensure it complies with applicable laws.

Collaboration Agreement
Between
[•]

(hereinafter referred to as “[A]” or as a “Party”)

and

[•]

(hereinafter referred to as “[B]” or as a “Party”; and collectively with [A], the “Parties”)

WHEREAS the principle of the ABP is to have a single Passport for each Athlete, managed by a
single Anti-Doping Organization (ADO) referred to as the Passport Custodian;

WHEREAS [A] is an [ADO] that has Testing jurisdiction over certain Athletes and wishes to perform
Passport Testing in respect of such Athletes;

WHEREAS [B] is an [ADO] that also has Testing jurisdiction over those same Athletes and also
wishes to perform Passport Testing in respect of such Athletes;

WHEREAS [A] and [B] wish to establish a framework to govern the exchange of ABP-Related
Information (as defined below) and the mutual recognition of Athlete Biological Passport (ABP)
program outcomes between [A] and [B] to enhance the efficiency and effectiveness of their respective
ABP programs.

THEREFORE, it is agreed upon between the Parties:

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Clause 1 - Definitions

Capitalized and italicized terms used in this Agreement shall have the meanings ascribed to them
under the World Anti-Doping Code (“Code”) while capitalized and underlined terms shall have the
meanings ascribed thereto in an International Standard, both as amended from time to time. [For ease
of reference, relevant definitions have been reproduced in Schedule 1 attached hereto.]

Additional definitions created for the purposes of this Agreement shall be capitalized and have the
following meanings:

1.1 “ABP-Related Information” means any information related to the administration and
management of an ABP program, including longitudinal profiles of biological Markers; results
of the Adaptive Model on Markers data and other information relevant to the evaluation of
Markers; APMU and Expert reviews; and Doping Control and Results Management information
related to a relevant Passport.

1.2 “Agreement” means this Collaboration Agreement, including its preamble.

1.3 “ABP Operating Guidelines” means the most recent version of the ABP Operating Guidelines
adopted by WADA and available on WADA’s website (www.wada-ama.org).

1.4 “Representative” means an employee, officer, Third-Party Agent or other designated adviser
or agent of a Party.

Clause 2 – Passport Testing and Information Sharing

2.1 Where appropriate and necessary to ensure proper coordination and efficient allocation of
Passport Testing activities and resources between the Parties, the Parties agree to provide
each other with:

(a) a list of Athletes (over which [A] and [B] both have Testing jurisdiction) within their
respective Registered Testing Pool (RTP) or other testing pool (TP) who will be subject
to ABP Testing in accordance with their test distribution plans (TDP), and to discuss the
composition of such TDP with the other Party in advance; and

(b) a list of Events where each Party intends to conduct pre-Competition ABP testing.

2.2 For the avoidance of doubt, nothing in this Clause 2 shall prevent [A] or [B] from Testing any
Athlete within its Testing jurisdiction for the purposes of its ABP at any time, irrespective of the
Athlete’s status on [A] or [B]’s TDP.

2.3 [A] shall conduct Testing of the Athletes in [A]’s TDP, and [B] shall conduct Testing of Athletes
in [B]’s TDP, including by means of Target Testing. For such purposes:

(a) Each of [A] and [B] is responsible for ensuring that it has proper Testing jurisdiction with
regard to any Testing activities;

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 (b) Each of [A] and [B] is responsible for ensuring that Samples are collected in compliance
with the Code, the International Standards, and the ABP Operating Guidelines;

(c) Each of [A] and [B] shall each bear its own costs of Testing (including the costs of
storage, transportation and analysis of Samples); and

(d) The Parties, either directly or through their respective APMUs may share ABP-Related
Information with each other as regards the Target Testing of Athletes in [A]’s TDP or
[B]’s TDP, as the case may be.

2.4 Each Party agrees that it shall, at its own cost, exclusively use ADAMS, and require its
respective APMU to use ADAMS, for recording doping control forms and other ABP-Related
Information relating to any Athlete tested as part of a Party’s ABP program.

2.5 Where an Athlete within a Party’s testing pool has been tested as part of a Party’s ABP
program, the relevant Party shall upload and record all relevant ABP-Related Information on
ADAMS, or ensure that it is being uploaded and recorded by its APMU, as soon as reasonably
practical following the test.

2.6 The Party designated as the Passport Custodian, in accordance with clause 3.1 below, agrees
that it shall provide the other Party with read-only access to relevant Athlete Passports in
ADAMS. The Parties acknowledge that they may also set specific sharing rules within ADAMS
to permit each of them automatic access to Passports of Athletes over whom they both have
Testing jurisdiction.

2.7 The Parties acknowledge and agree that where a Party has granted access to a Passport to
the other Party within ADAMS, such other Party may share ABP-Related Information with its
duly authorized Representatives (including its APMU and members of its Expert Panel) strictly
for the purposes of its ABP program.

2.8 If for whatever reason a Passport or other relevant ABP-Related Information cannot be readily
accessed by a Party through ADAMS, the Passport Custodian shall provide the relevant
Passport or other information to the other Party in such other secure manner as the other Party
may reasonably request.

Clause 3 – Passport Results Management Process

3.1 For each Athlete included in both [A] and [B]’s Registered Testing Pool or other relevant testing
pool, the Parties shall agree which Party should act as Passport Custodian to maximise the
effectiveness and efficiencies of each Party’s respective ABP program, and to ensure the
Passport Custodian is the Party that conducts more frequent Testing in respect of a given
Athlete.

3.2 The Passport Custodian is responsible for Results Management in accordance with the then-
current TD on Result Management Requirements for the ABP adopted by WADA. For Athletes
included in both [A] and [B]’s TDP, Passports shall be reviewed after each test by the APMU

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 of the Passport Custodian independently of whether [A] or [B] was the Testing Authority that
conducted the last Passport test.

3.3 To the extent this information is not available to the other Party via ADAMS, The Parties shall
immediately notify each other in writing of the referral of any Athlete’s Passport for review by
the other Party’s ABP Expert panel in accordance with the ABP Operating Guidelines, as well
as the outcome of such review. The Parties shall also notify each other upon request of an
updated list of the members of their ABP Expert panel.

3.4 For the avoidance of doubt, relevant ABP-Related Information collected by [A] and [B] should,
whenever possible, be consolidated for the purposes of pursuing a potential anti-doping rule
violation (ADRV) or other Results Management procedure against an Athlete in accordance
with the Code and International Standards.

3.5 Where the Passport Custodian decides not to proceed with an asserted ADRV in connection
with a Passport, such decision will not affect the ability of the other Party or WADA to appeal
such decision.

Clause 4 –Privacy and Security

4.1 The Parties acknowledge and agree that the sharing of ABP-Related Information (including
Personal Information) under this Agreement is necessary to allow each Party to effectively and
efficiently manage its ABP program and otherwise fulfill its obligations under the Code and the
International Standards.

4.2 The Parties agree and acknowledge that each Party is responsible for complying with
applicable data protection, privacy and data security laws as well as the Code and the
International Standards with respect to any ABP-Related Information exchanged pursuant to
this Agreement.

4.3 Without limiting the generality of the foregoing, each Party shall:

(a) ensure that it has a valid legal authority or basis to share ABP-Related Information with,
or receive such information from, the other Party in connection with this Agreement, as the
case may be;

(b) treat any ABP-Related Information that it receives from the other Party as confidential
information at all times and only Process such information for the anti-doping purposes set
out in this Agreement and in accordance with the International Standard for the Protection
of Privacy and Personal Information (ISPPPI);

(c) protect any ABP-Related Information that it receives from the other Party by applying all
necessary and appropriate security safeguards, including physical, organizational,
technical, environmental and other measures to prevent against a Security Breach;

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 (d) only grant access and access privileges to any ABP-Related Information that it receives
from the other Party to its duly authorized Representatives (including its APMU and
members of its Expert panel) on a need-to-know basis;

(e) subject to clause 4.3(d) above, not disclose any ABP-Related Information that it receives
from the other Party to any other Person without the express prior written consent of the
other Party, unless the disclosure is otherwise required by law;

(f) ensure any Person (including any duly authorized Representative) with access to ABP-
Related Information is informed of the confidential nature of such information, of the limited
purposes for which it can be used, and has entered into a written agreement to preserve
such confidentiality; and

(g) notify the other Party promptly of any Security Breach affecting any ABP-Related
Information received under this Agreement and take immediate steps to rectify any such
Security Breach.

Clause 5 – Effective Date and Termination

5.1 This Agreement shall become effective as of the date of the latest signature appearing on the
signature page below and will remain in effect until terminated, except for clause 4 (Privacy
and Security) and sub-clause 5.4 of this Agreement which shall survive termination.

5.2 Either Party may terminate this Agreement for any reason by providing thirty (30) days’ written
notice to the other Party.

5.3 Either Party may terminate this Agreement immediately if the other Party commits a material
breach of any term of this Agreement and (if such breach is remediable) fails to remedy that
breach within a period of thirty (30) days after being notified in writing of the breach.

5.4 The Parties agree that after the effective date of termination of this Agreement, and subject to
applicable data protection and privacy laws, each Party may continue to use all information
provided to it by the other Party pursuant to this Agreement, provided that such information is
only used for anti-doping purposes in accordance with the Code and the International
Standards and continues to be maintained in accordance with the privacy and security
requirements set out in this Agreement, the ISPPPI and applicable laws.

Clause 6 – Authority

6.1 The Parties hereby represent that they have the full power and authority to enter into and
perform this Agreement, and the Parties know of no agreement, promises, or undertakings
that would prevent the full execution and performance of this Agreement.

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6.2 Notwithstanding the above and for the avoidance of doubt, the Parties acknowledge and agree
that nothing in this Agreement affects or modifies their respective rights and obligations, and
those of other relevant third parties, under the “Agreement Governing the Use and Sharing of
Information in ADAMS” that the Parties entered into with WADA.

Clause 7 - Indemnity

Each Party (the “Breaching Party”) shall indemnify and hold harmless the other Party (the “Non-
Breaching Party”) against any and all costs, charges, damages, expenses and losses (including
costs incurred in recovering same) that are incurred by the Non-Breaching Party as a result of any
breach of this Agreement by the Breaching Party up to a maximum of [•].

Clause 8 – Miscellaneous

8.1 This Agreement is intended to be the sole and complete statement of obligation of the Parties
as to the subject matter hereof, and supersedes all previous agreements, understandings,
negotiations and proposals as to such subject matter.

8.2 The failure of either Party at any time to demand strict performance of the terms of the
Agreement shall not be construed as a waiver of the right to demand or receive complete
performance of all rights, promises and covenants in this Agreement.

8.3 This Agreement does not establish either Party to be the agent of the other Party or create a
joint venture or similar relationship between the Parties and no Party shall have the power to
obligate or bind the other Party in any manner whatsoever.

8.4 Neither Party may assign, directly or indirectly, by operation of law, change of control or
otherwise, this Agreement or any of its rights and obligations hereunder, without the prior
written consent of the other Party, which shall not be unreasonably withheld.

8.5 The Parties agree that any and all amendments to this Agreement must be made in writing
and be signed by both Parties.

8.6 If any provision or provisions of this Agreement is be held to be invalid, illegal, or

unenforceable, such provision shall be severed from this Agreement to the extent required
and the validity, legality, and enforceability of the remaining provisions shall not in any way be
affected or impaired thereby.

8.7 A Person who is not a party to this Agreement shall not have any rights under or in connection
with this Agreement. The rights of the Parties to terminate, rescind or agree any variation,
waiver or settlement under this Agreement are not subject to the consent of any Person that
is not a party to this Agreement.

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8.8 Section and other headings in this Agreement are for convenience of reference only and shall
not constitute a part of or otherwise affect the meaning or interpretation of this Agreement.

Clause 9 - Notices

9.1 Any notice required to be given under this Agreement shall be in writing and shall be delivered
personally, sent by email, fax or sent by commercial courier, to the other Party required to
receive the notice at the contact information set out below:

(a) [A]:
For the attention of: [•]
Address: [•]
Email: [•]
Fax number: [•]

(b) [B]:
For the attention of: [•]
Address: [•]
Email: [•]
Fax number: [•]

or at such other address, email or fax as the relevant Party may specify by notice in writing to
the other Party.

9.2 Any notice shall be deemed to have been duly given:

(a) if delivered personally, at the time of delivery at the address referred to in Clause 11.1;
(b) if delivered by commercial courier, at the time of signature of the courier's receipt;
(c) if delivered by email, at the date and time indicated on such email; or
(d) if sent by fax, at the time of transmission.

Clause 10 – Applicable Law and Jurisdiction

10.1 This Agreement and any dispute or claim arising out of or in connection with it or its subject
matter shall be governed by and construed in accordance with the law of [•].

10.2 The Parties agree that any dispute, arguments or claims arising with respect to or in
connection with the execution of this Agreement (as well as any subsequent amendment
hereof, including, for example, its structure, validity, effectiveness, interpretation, execution,
infringement or termination, and also any non-contractual claim relating hereto) shall be the
object of an amicable resolution. In the absence of amicable resolution, the dispute shall be
submitted to the exclusive jurisdiction of the Court of Arbitration for Sport (CAS) in Lausanne,

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 Switzerland, and settled definitively in accordance with the Code of Sports-related Arbitration.
The panel will consist of one arbitrator. The language of the arbitration will be [•].

Clause 11 - Signatories

The signatories to this Agreement hereby warrant that they have read and agree to the terms,
conditions and provisions of this Agreement, including any Appendices, and have full power and
authority to sign for and bind their respective organizations.

Clause 12 - Counterparts

This Agreement may be executed in any number of counterparts, each of which shall be deemed an
original but all of which shall constitute one and the same instrument.

In the name and on behalf of

[A]

________________________

……………………..[Name, Position]

Date: ____________________

In the name and on behalf of

[B]

________________________

……………………..[Name, Position]

Date: ____________________

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