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