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WADA publishes revised Technical Documents and new Technical Letters

The World Anti-Doping Agency (WADA) publishes revised versions of five Technical Documents (TDs) (along with their Summaries of Modifications); as well as, two new Technical Letters (TLs), which were approved by WADA’s Executive Committee on 20 May 2021.
 
REVISED TECHNICAL DOCUMENTS

Under the International Standard for Laboratories (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 address scientific and technological advances in the performance of anti-doping tests and the reporting of test results, as well as to reflect feedback received from WADA-accredited Laboratories and other WADA stakeholders.

The revised TDs, along with their Summaries of Modifications, are listed below and are available and indexed on WADA’s website:

  1. TD2021BAR – Analytical Requirements for the Hematological Module of the Athlete Biological Passport, along with the Summary of Modifications.

    In this revised version of the TD2021BAR, in Article 6.1, the reference to International Standard for Testing and Investigations (ISTI) Annex K, Article K.2.4 was replaced by ISTI Annex I, Article I.2.7.


     
  2. TD2021EPO – Harmonization of Analysis and Reporting of Erythropoietin (EPO) and other Erythropoietin-Receptor Agonists (ERAs) by Polyacrylamide Gel Electrophoretic (PAGE) Analytical Methods, along with the Summary of Modifications.

    In this revised version of the TD2021EPO, the implementation date of the TD was postponed to 1 September 2021. This modification, which was requested by the WADA EPO Working Group, was triggered by the difficulties faced by certain laboratories in becoming compliant with the new requirements of the TD2021EPO under the existing COVID-19 pandemic restrictions.
     

  3. TD2021IRMS – Detection of Synthetic Forms of Prohibited Substances by GC/C/IRMS, along with the Summary of Modifications.

In this revised version of the TD2021IRMS, the following points were modified:

  • Article 1.0: Clarification that the general technical recommendations and method validation requirements described in this TD shall also be applied to the analysis of 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE), notwithstanding that these two substances are subject of a separate TD (TDNA).
  • Article 1.1.3: Clarification that the same endogenous reference compounds (ERCs) and target compounds (TCs) that led to the “A” sample Adverse Analytical Finding shall be measured in the “B” sample.
  • Article 2.1.1: Clarification that sample volume adjustment may allow the analysis of TCs and ERCs present in the sample at a concentration lower than the respective limit of quantification (LOQ) as long as the signal is within the validated linearity range of the IRMS instrument for that particular analyte.
  • Article 2.1.2: The reference to the monitoring of the precision of the 45/44 and 46/44 ratios as a check for the stability of CO2 pulses has been removed.
  • Article 2.1.2: Equation 3 for the mass balance adjustment of measured δ13C values of acetylated compounds has been reviewed. The term “C” in Eq. 3 had been misquoted as representing the concentration and therefore has been removed.
  • Article 2.3.2: Clarification under criterion iv. that the criterion for the ERC-A and ERC-Etio pairs may be applied only if no other criterion based on the measurement of T, 5α-Adiol and/or 5β-Adiol can be used.
  • Article 2.4.2: Clarification that the laboratory shall explain, in the comments section of the Test Report in ADAMS, the reason(s) why pregnanediol (PD) could not be used as the ERC1.

    4. TD2021NA – Harmonization of Analysis and Reporting of 19-Norsteroids Related to Nandrolone, along with the Summary of Modifications.

    In this revised version of the TD, the unnecessary requirement to inject a blank urine sample before the sample under confirmation was removed from Article 3.2.3. It is considered that the potential of any contamination shall be addressed by the laboratory during method validation, and that the use of negative quality control (NQC) and positive quality control (PQC) samples is sufficient to monitor any issues during routine analysis. 

    5. TD2021EAAS – Measuring and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS) Markers of the Urinary Steroid Profile, along with the Summary of Modifications.

    In this revised version of the TD, the misquotation of some article numbers, which erroneously referenced articles that no longer exist in the TD2021IRMS, was corrected in Articles 3.3.1 and 3.3.2. Therefore, those specific TDIRMS article numbers have been removed and replaced by a general reference to the TDIRMS.

    In addition, it was clarified in Article 3.3.2 that the Laboratory shall also report the measured specific gravity of the “B” Sample.

DEADLINES FOR IMPLEMENTING THE REVISED TDs

All WADA-accredited Laboratories are required to implement these TDs in their procedures by the following deadlines (WADA-approved Laboratories are only expected to implement TD2021BAR):

1 June 2021:

  • TD2021BAR
  • TD2021NA
  • TD2021EAAS
  • TD2021IRMS

1 September 2021:

  • TD2021EPO

NEW TECHNICAL LETTERS

Under the ISL, WADA’s TLs are issued in letter format on an ad-hoc basis in order to provide direction to the WADA-accredited and WADA-approved Laboratories and other stakeholders on particular issues related to the analysis, interpretation and reporting of results for specific Prohibited Substance(s) and/or Prohibited Method(s) or to the application of specific laboratory procedures.

The TLs below were developed as a result of the recommendations made by the WADA Working Group on Contaminants and are available and indexed on WADA’s website:

  • TL23 – Minimum Reporting Level for Certain Substances known to be Potential Meat Contaminants

    This new TL includes clarification regarding the reporting and results management of findings for certain substances (clenbuterol, ractopamine, zeranol and zilpaterol) which may be used as growth promoters for livestock in some countries and therefore may be associated with findings resulting from the consumption of contaminated meat.

  • TL24 – Minimum Reporting Level for Certain Diuretics that are known Contaminants of Pharmaceutical Products

    This new TL includes clarification regarding the reporting and results management of findings for certain diuretics (acetazolamide, bumetanide, furosemide, hydrochlorothiazide, torsemide and triamterene) which are known to be found as contaminants of some pharmaceutical products.

DEADLINE FOR IMPLEMENTING THE NEW TECHNICAL LETTERS

All WADA-accredited and WADA-approved Laboratories are required to implement these new TLs in their procedures by 1 June 2021.

Should you have any questions or comments regarding these revised Technical Documents and new Technical Letters, please contact WADA’s Science Department at: science@wada-ama.org.