the wada proficiency testing program as an integral part of the fight against doping in sport

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INTERNATIONAL BODIES The WADA Proficiency Testing Program as an integral part of the fight against doping in sport Victoria Ivanova Thierry Boghosian Olivier Rabin Received: 26 March 2007 / Accepted: 30 April 2007 / Published online: 6 June 2007 Ó Springer-Verlag 2007 Abstract This article provides a brief perspective of the World Anti-Doping Agency (WADA) in the context of the fight against doping in sport and of the WADA Proficiency Testing Program as an essential element of the World Anti- Doping Program. The WADA Proficiency Testing Program exists within the framework of the WADA-accredited laboratories and is aimed at improving the effectiveness of the fight against doping by testing the ability of the labo- ratories to reliably identify and measure the substances and methods defined in the WADA Prohibited List. The paper provides an overview of the WADA Proficiency Testing scheme with respect to organization, test composition and evaluation of anti-doping methods and techniques. Scien- tific research is mentioned in the context of WADA’s involvement in generating reference materials for improvement of analytical activities of the WADA- accredited laboratories. WADA’s funding of a reference material for 19-norandrosterone in human urine is illus- trated as an example. Keywords Accreditation Á Anti-doping Á Proficiency testing Á WADA Introduction The modern history of the fight against doping in sport is closely connected to the development of methods and tests for the detection of prohibited substances. Testing labora- tories have become an important part of anti-doping re- search efforts and anti-doping rules enforcement. The purpose of this article is to describe the WADA Proficiency Testing (PT) Program as an integral part of global fight against doping in sport. Research in doping detection methods gained focus and structure with the emergence of anti-doping laboratories. In 1979, the International Association of Athletics Federa- tions (IAAF) was the first international federation to implement an anti-doping program and to authorize labo- ratories to analyze doping control samples from their ath- letes. The International Olympic Committee (IOC), following the IAAF’s lead, initiated an annual accreditation of anti-doping laboratories two years later. World anti-doping program The collective efforts of the sport movement and govern- ments to fight against doping culminated in the creation of the World Anti-Doping Agency (WADA) in November 1999. WADA was established on the basis of a unique collaboration between the leading representatives of the international sports movement and of the governments of the world. Since its inception, WADA has carried out its mandate to establish a comprehensive World Anti-Doping Program (Program) with the key objective to improve and harmonize the global fight against doping in sport. There are three levels to the Program: the World Anti-Doping Code (Code) [1], the International Standards, and Models of Best Practice. The Code and the International Standards are mandatory for those participating in the Program. The World Anti-Doping Code, the document harmo- nizing anti-doping rules across all sports and all countries, came into force on 1 January 2004, and was adopted and implemented by all Olympic International Sport V. Ivanova (&) Á T. Boghosian Á O. Rabin World Anti-Doping Agency (WADA), 800 Place Victoria (Suite 1700), PO Box 120, Montreal, QC, Canada H4Z 1B7 e-mail: [email protected] 123 Accred Qual Assur (2007) 12:491–493 DOI 10.1007/s00769-007-0283-4

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Page 1: The WADA Proficiency Testing Program as an integral part of the fight against doping in sport

INTERNATIONAL BODIES

The WADA Proficiency Testing Program as an integralpart of the fight against doping in sport

Victoria Ivanova Æ Thierry Boghosian ÆOlivier Rabin

Received: 26 March 2007 / Accepted: 30 April 2007 / Published online: 6 June 2007

� Springer-Verlag 2007

Abstract This article provides a brief perspective of the

World Anti-Doping Agency (WADA) in the context of the

fight against doping in sport and of the WADA Proficiency

Testing Program as an essential element of the World Anti-

Doping Program. The WADA Proficiency Testing Program

exists within the framework of the WADA-accredited

laboratories and is aimed at improving the effectiveness of

the fight against doping by testing the ability of the labo-

ratories to reliably identify and measure the substances and

methods defined in the WADA Prohibited List. The paper

provides an overview of the WADA Proficiency Testing

scheme with respect to organization, test composition and

evaluation of anti-doping methods and techniques. Scien-

tific research is mentioned in the context of WADA’s

involvement in generating reference materials for

improvement of analytical activities of the WADA-

accredited laboratories. WADA’s funding of a reference

material for 19-norandrosterone in human urine is illus-

trated as an example.

Keywords Accreditation � Anti-doping � Proficiency

testing � WADA

Introduction

The modern history of the fight against doping in sport is

closely connected to the development of methods and tests

for the detection of prohibited substances. Testing labora-

tories have become an important part of anti-doping re-

search efforts and anti-doping rules enforcement. The

purpose of this article is to describe the WADA Proficiency

Testing (PT) Program as an integral part of global fight

against doping in sport.

Research in doping detection methods gained focus and

structure with the emergence of anti-doping laboratories. In

1979, the International Association of Athletics Federa-

tions (IAAF) was the first international federation to

implement an anti-doping program and to authorize labo-

ratories to analyze doping control samples from their ath-

letes. The International Olympic Committee (IOC),

following the IAAF’s lead, initiated an annual accreditation

of anti-doping laboratories two years later.

World anti-doping program

The collective efforts of the sport movement and govern-

ments to fight against doping culminated in the creation of

the World Anti-Doping Agency (WADA) in November

1999. WADA was established on the basis of a unique

collaboration between the leading representatives of the

international sports movement and of the governments of

the world. Since its inception, WADA has carried out its

mandate to establish a comprehensive World Anti-Doping

Program (Program) with the key objective to improve and

harmonize the global fight against doping in sport. There

are three levels to the Program: the World Anti-Doping

Code (Code) [1], the International Standards, and Models

of Best Practice. The Code and the International Standards

are mandatory for those participating in the Program.

The World Anti-Doping Code, the document harmo-

nizing anti-doping rules across all sports and all countries,

came into force on 1 January 2004, and was adopted

and implemented by all Olympic International Sport

V. Ivanova (&) � T. Boghosian � O. Rabin

World Anti-Doping Agency (WADA), 800 Place Victoria

(Suite 1700), PO Box 120, Montreal, QC, Canada H4Z 1B7

e-mail: [email protected]

123

Accred Qual Assur (2007) 12:491–493

DOI 10.1007/s00769-007-0283-4

Page 2: The WADA Proficiency Testing Program as an integral part of the fight against doping in sport

Federations prior to the Athens Olympic Games in the

summer of 2004. Governments, in turn, have drafted an

official declaration (‘‘The Copenhagen Declaration’’),

signed by 186 of them as of today, indicating their com-

mitment to the Code. Governments are now individually

ratifying the UNESCO International Convention against

Doping in Sport to formalize their commitment and align

their domestic policies with the Code.

Based on the Code provisions, WADA has developed

the International Standard for Laboratories (ISL) [4], the

main document that sets the standards for laboratory anti-

doping procedures around the world. The ISL and its re-

lated technical documents seek to assist anti-doping labo-

ratories in producing test results that are comparable and

recognized around the world, in both a scientific and legal

sense. WADA is striving to achieve this harmonization

through the WADA Proficiency Testing Program.

WADA Proficiency Testing Program

Anti-doping laboratories have an important role in the

harmonization intended by the Code. Since 2004, WADA

has been responsible for monitoring anti-doping laborato-

ries’ competency worldwide. Currently, 34 laboratories

around the world are authorized to conduct doping control

sample analysis, and several other laboratories throughout

the world have expressed interest in entering the WADA

accreditation process.

WADA accreditation is predicated upon compliance

with two international standards-ISO/IEC 17025 [3] and

the ISL. In order to harmonize the ISL across various na-

tional testing regulations, WADA has established close ties

with both international and national standard-setting bod-

ies. WADA has initiated a close cooperation with the

International Laboratory Accreditation Cooperation

(ILAC) in order to facilitate the process of concurrent

assessment of laboratories for compliance with both stan-

dards.

Participation in the WADA Proficiency Testing (PT)

Program is mandatory for all WADA–accredited labora-

tories. The main objective of the WADA Proficiency

Testing Program is to evaluate laboratory competency

through continuous assessment of their performance. The

PT scheme provides the laboratories with opportunities to

compare their results and aims to improve uniformity of

test results among laboratories.

The WADA Proficiency Testing Program also incorpo-

rates educational opportunities for the WADA-accredited

laboratories. The purpose of the WADA Educational Pro-

gram is to harmonize identification and reporting of diffi-

cult-to-detect substances as well as substances newly added

to the WADA Prohibited List. In addition, a double blind

PT sample program is in the process of implementation,

which aims to insert PT samples at the collection site,

therefore indistinguishable from true athlete samples, in

order to evaluate quality and time considerations in the

chain of events from collection to analysis and reporting of

results.

The effectiveness of the global fight against doping

depends on the ability of testing laboratories to reliably

identify and measure the substances prohibited in sport as

defined by the WADA List of Prohibited Substances and

Methods [2]. WADA constantly monitors the capabilities

of the anti-doping laboratories through a continuous pro-

ficiency testing scheme.

The WADA PT program measures laboratory perfor-

mance during the year and comprises four PT rounds. Each

regular annual PT cycle consists of at least 20 proficiency

test samples, including prohibited substances as well as

blank samples. Prohibited substances for the WADA PT

scheme are selected from the WADA Prohibited List and

involve substances from all prohibited drug classes. Sam-

ples are prepared mainly based upon excretion studies in

order to encompass the metabolism of drugs, but PT

samples with an associated threshold for well-known

metabolite(s) may be produced by spiking.

At least one sample per PT round will contain a

threshold substance for which quantification and estimate

of uncertainty are required. When a quantitative determi-

nation has been performed, the results can be based on the

true or consensus value of the sample analysed and a target

standard deviation which is set to the expected precision of

the method. Statistical evaluation of the laboratory results

is performed in accordance with ISO 13528 [5] by an

independent expert who presents the statistical results of

each proficiency testing round for consideration by the

WADA Laboratory Committee.

Though the quantitative aspect in sample determination

is a critical factor in the evaluation of laboratories, the great

majority of substances from the WADA Prohibited List are

non-threshold substances, the detection of which does not

require quantification. For qualitative substances, a mini-

mum required performance level (MRPL) has been estab-

lished in order to ensure that all WADA-accredited

laboratories can report the presence of prohibited sub-

stances in a uniform way at a level that is considered a

minimal requirement of sensitivity.

The actual composition of PT samples supplied to dif-

ferent laboratories may vary but, within the annual PT

cycle, all participating laboratories are expected to have

analyzed the same total number of samples. In addition, a

PT sample may contain more than one prohibited sub-

stance, metabolite, or marker of a prohibited substance or

method. A PT sample will not contain more than three

substances or their metabolites. It is possible, however, that

492 Accred Qual Assur (2007) 12:491–493

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Page 3: The WADA Proficiency Testing Program as an integral part of the fight against doping in sport

the sample will contain multiple metabolites of a single

substance, which would represent the presence of a single

prohibited substance. Sample concentrations are set at

levels that could be expected in the urine of doped athletes.

Therefore, this should allow detection of the analytes by

commonly-used screening techniques. In the analysis of PT

samples, laboratories are expected to employ only methods

and procedures that are within the laboratory’s scope of

accreditation.

The WADA Proficiency Testing scheme represents the

collaborative efforts of the WADA sample provider, the

WADA Laboratory Committee, the accredited laboratories

and the laboratories in the probationary phase of WADA

accreditation.

The WADA Laboratory Committee is the main con-

sultative body for all laboratory activities. The Committee

evaluates laboratory performance in each proficiency test-

ing round in accordance with the International Standard for

Laboratories and provides its recommendations to the

laboratories as well as other WADA decision bodies, such

as the WADA Executive Committee.

Scientific research

As anti-doping methods and techniques become more

sophisticated, WADA undertakes substantial investment

into scientific research aiming to discover methods that

allow identification of new doping substances and methods,

as well as to develop improved detection tests. A priority of

WADA’s scientific research program is to provide essential

funding to anti-doping laboratories, as well as other com-

petent scientific research groups, in order to improve the

ability to detect doping substances and methods.

Another target area of WADA’s scientific research

program is the development of reference materials for

prohibited substances. The results of several proficiency

testing rounds have pointed to a lack of reliable reference

materials for a number of substances that are commonly-

abused by doped athletes. This has given WADA the

opportunity to define and prioritize research funding for

developing reference materials to be used by all anti-dop-

ing laboratories. The type of reference material produced is

based upon the need to improve measurement precision of

threshold substances and to provide reference materials

that are not otherwise available.

Availability of Certified Reference Materials (CRMs) is

of major importance to WADA-accredited laboratories.

WADA has already funded development and production of

several CRMs including for 19-norandrosterone, T/E ratio

and metabolites of androstenedione, DHEA, 19-norster-

oids, 1-testosterone and mesocarb.

One such example is 19-norandrosterone (the major

metabolite of the anabolic steroid nandrolone), a substance

that represents a significant proportion of the adverse

analytical findings reported by the WADA-accredited lab-

oratories every year [6]. The development of a reliable and

controlled CRM in human urine was initiated in order to

further improve the detection of 19-norandrosterone at the

established threshold (2 ng ml–1) in urine. Both solution

and urine matrix CRMs have been produced by the Na-

tional Measurement Institute of Australia under a research

grant from WADA.

References

1. World Anti-Doping Code (2003) WADA, Montreal, Canada.

http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id = 250

2. The International Standard for Laboratories (version 4.0, August

2004). WADA, Montreal, Canada. http://www.wada-ama.org/en/

dynamic.ch2?pageCategory.id=372

3. ISO/IEC 17025 (2005) General requirements for the competence

of testing and calibration laboratories, International Organization

for Standardization, Geneva

4. The 2007 Prohibited List (2007) WADA, Montreal, Canada. http://

www.wada-ama.org/en/prohibitedlist.ch2

5. ISO 13528 (2005) Statistical methods for use in proficiency testing

by interlaboratory comparisons, International Organization for

Standardization, Geneva

6. WADA Laboratory Statistics (2005) WADA, Montreal, Canada.

http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id =335

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