WADA releases Laboratory Technical Documents for 2021

The World Anti-Doping Agency (WADA) publishes today the following Technical Documents (TDs) for 2021 and Summaries of Modifications which were approved by WADA’s Executive Committee, via circulatory vote, on 21 December 2020.

This particular review of WADA’s TDs was triggered by the need to bring the following ones in line with the 2021 World Anti-Doping Code (Code) and the 2021 International Standard for Laboratories (ISL), which both come into force on 1 January 2021.

Under the ISL, WADA’s TDs are issued to provide direction to WADA-accredited Laboratories, WADA-approved Laboratories and other stakeholders on specific technical or procedural issues. As part of WADA’s mandate to enhance anti-doping activities under the World Anti-Doping Code, TDs undergo periodic revisions to reflect scientific and technological advances in the performance of anti-doping tests and the reporting of test results. They are refined and revised in consultation with WADA stakeholders.

2021 TECHNICAL DOCUMENTS

1. TD2021BAR - Analytical Requirements for the Hematological Module of the Athlete Biological Passport.

The TD2021BAR replaces the former TD2019BAR. In this revised version of the TD, relevant definitions have been updated and further clarification introduced, where relevant, to facilitate interpretation.

2. TD2021CG/LH - Analysis, Reporting and Management of Urinary human Chorionic Gonadotrophin (hCG) and Luteinizing Hormone (LH) Findings in Male Athletes.

The TD2021CG/LH replaces the former TD2019CG/LH, which has been modified to include the following main changes: the possible use of total hCG assays for the initial testing procedure has been reintroduced to facilitate the analytical strategy; and further clarifications regarding the selection of hCG assays for the initial testing and confirmation procedures, as well as the management of reported hCG results, are now provided. Terms and definitions have been updated where relevant.

3. TD2021DL - Decision Limits for the Confirmatory Quantification of Exogenous Threshold Substances by Chromatography-based Analytical Methods.

The TD2021DL replaces the former TD2019DL Version 2, which has been modified to include the following main changes: sections have been reorganized to facilitate interpretation; the title has been adjusted to better reflect the revised scope of the TD, which has been redirected towards the confirmatory quantification of exogenous threshold substances when using Chromatography-based methods; the previous section on method validation has been removed since it is now well described in other documents; the applicable Decision Limits (DLs) and concentration levels of the exogenous threshold substances shall be reported to three significant figures; the examples in the text were updated accordingly; terms and definitions have been updated where relevant; and finally, a new Annex B was created to detail the values for the specific gravity-adjusted DLs.

4. TD2021EPO - Harmonization of Analysis and Reporting of Erythropoietin (EPO) and other Erythropoietin-Receptor Agonists (ERAs) by Polyacrylamide Gel Electrophoretic (PAGE) Analytical Methods.

The TD2021EPO replaces the former TD2014EPO, which has been modified to include the following main changes: adjustment of the title to reflect the current classification of these erythropoiesis stimulating agents in the 2021 Prohibited List; addition of test sensitivity controls as an additional, optional requirement for initial testing and confirmation procedures; definition of minimum required performance limits (MRPL) for detection of ERAs; mandatory immunopurification of ERAs before PAGE analysis; use of discontinuous transfer buffers for immunoblotting; use of a biotinylated primary anti-EPO antibody; and conditions to report an Atypical Finding for ERAs. Terms and definitions have been updated where relevant.

5. TD2021GH – Human Growth Hormone (hGH) Isoform Differential Immunoassays for Doping Control Analyses.

The TD2021GH replaces the former TD2019GH, which has been modified to include minimal changes that primarily affect its formatting as well as the updating of terms and definitions where relevant.

6. TD2021IDCR - Minimum Criteria for Chromatographic-Mass Spectrometric Confirmation of the Identity of Analytes for Doping Control Purposes.

The TD2021IDCR replaces the former TD2015IDCR, which has been modified to include the following main changes: clarifications have been provided regarding the selection and use of the applied Reference Diagnostic Ion in order to obtain the Retention Time and to calculate the Relative Abundances of the Analyte’s Diagnostic Ions; and the definitions of Reference Diagnostic Ion, Reference Specimen, Retention Time and Relative Retention Time have been included to facilitate interpretation. Other terms and definitions have been updated where relevant.

7. TD2021IRMS - Detection of Synthetic Forms of Prohibited Substances by GC/C/IRMS.

The TD2021IRMS replaces the former TD2019IRMS, which has been modified to include the following main changes: adjustment of the title to better reflect the revised scope of the TD, which has been expanded to include the analysis of other prohibited substances in addition to endogenous anabolic androgenic steroids (EAAS); addition of new target compounds (TC): 6a-hydroxy-androstenedione, epiandrosterone sulfate, prednisone and prednisolone; addition of pregnanetriol (PT) as an endogenous reference compound (ERC); calculation of absolute Δδ¹³C values; revision of uc_Max requirements; requirement to consider results obtained with two different ERCs for reporting an Adverse Analytical Finding (with an updated Annex A on Selection and Use of ERCs); and review of some interpretation criteria (e.g. for A and Etio) in Annex B. Terms and definitions have been updated where relevant.

8. TD2021LCOC - Laboratory Internal Chain of Custody.

The TD2021LCOC replaces the former TD2009LCOC, which has been modified to include the following main change: the TD has been completely reorganized to incorporate specific requirements for the maintenance and recording of chain of custody for sample reception, sample handling, aliquots, storage and sample transfers, including the use of electronic chain of custody systems. Terms and definitions have been updated where relevant.

9. TD2021LDOC - Laboratory Documentation Packages.

The TD2021LDOC replaces the former TD2019LDOC, which has been modified to include the following main changes: requirements for specific methods including Urine ABP, GC/C/IRMS, EPO and Blood ABP have been revised; and each annex has been updated based on the revised versions of the relevant TDs. Comments have been incorporated where relevant to provide further clarification of the requirements. Terms and definitions have been updated where relevant.

10. TD2021NA - Harmonization of Analysis and Reporting of 19-Norsteroids Related to Nandrolone.

The TD2021NA replaces the former TD2019NA, which has been modified to include the following main changes: better clarification of the possible endogenous origins of urinary 19-NA; better description of GC/C/IRMS performance characteristics and requirements when applied to 19-NA; instructions on the analysis to be performed when there are indications of 5a-reductase inhibitor activity in the sample; guidance to discriminate between oral consumption and injection of norsteroid preparations based on the pharmacokinetics of 19-NA excretion; and enhanced guidance for results interpretation and reporting in a tabulated form.

11. TD2021EAAS - Measuring and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS) Markers of the Urinary Steroid Profile.

The TD2021EAAS replaces the former TD2018EAAS, which has been modified to include the following main changes: adjustment of the title to better reflect the scope of the TD; reorganization of different sections to facilitate interpretation; definition of reporting limits for non-prohibited substances that may alter the steroid profile; revision of the modalities of confirmation procedure requests (CPR); and steroid profile reporting requirements for “A” and “B” samples. Terms and definitions have been updated where relevant.

12. TD2021APMU - Athlete Passport Management Unit (APMU) Requirements and Procedures.

The TD2021APMU replaces the former TD2019APMU, which has been modified to include the following main changes: modifications have been introduced regarding the review of ATPF-CPR notifications for samples in which factors impacting the steroid profile have been reported; the management of SSP-CPR notifications has been transferred to the APMU, including revised criteria for triggering SSP-CPR notifications; steps to identify urine exchange (tampering) have been included; and the section dedicated to the analysis of steroid esters has been shifted from the TDEAAS to this new version of TDAPMU. Terms and definitions have been updated where relevant.

DEADLINES

Please note that all WADA-accredited Laboratories, WADA-approved Laboratories (for TD2021BAR, TD2021LDOC (Annex E) and TD2021LCOC) and APMUs (for TD2021APMU) are required to implement these TDs in their procedures by the following deadlines:

1 April 2021:

• TD2021BAR
• TD2021CG/LH
• TD2021DL
• TD2021GH
• TD2021IDCR
• TD2021LCOC
• TD2021LDOC
• TD2021NA
• TD2021EAAS
• TD2021APMU (for APMUs only)

1 May 2021:

• TD2021EPO
• TD2021IRMS

The above TDs are available and indexed on WADA’s website.

Should you have any questions or comments regarding the 2021 Technical Documents, please feel free to contact WADA’s Science Department at: science@wada-ama.org.