Publications and Activities
Damoiseaux J, Cohen Tervaert JW,
Derksen R, Hamann D, Hooijkaas H, Klasen I, Kallenberg C,
Limburg P, and Smeenk R. Autoantibody standardization in the
Netherlands. The past, the present, and the future. Ann NY Acad
Sci (2009);173:10-14.
Abstract
Several initiatives have been
undertaken, independent of the European Autoantibody
Standardization Initiative (EASI), to standardize autoantibodies
in the Netherlands. The Dutch EASI team has made an inventory of
which initiatives on autoantibody standardization are already
available and what future plans for autoantibody standardization
exist. This inventory will subsequently be used to define
whatmay be addressed by the Dutch EASI team. The Diagnostic
Compass, initiated by the association of Dutch health insurance
companies, describes methods and relevance of laboratory tests,
including autoantibody tests. Recently, this initiative has been
taken over by an independent publisher. There is also a national
organization involved in developing guidelines in medicine,
including guidelines for autoantibody testing. In addition,
there is a national foundation for quality assessment in
clinical laboratories (SKML). The quality assessment includes a
wide array of autoantibodies. Samples are collected and
thoroughly investigated by reference laboratories.
Interpretation of results and advice to clinicians are part of
the program. Feedback on the results of this proficiency testing
is given in reports and during meetings to discuss trends,
technical issues, and new developments. The last initiative that
we discuss is the foundation Referentie Laboratorium Reuma
Serologie (RELARES),which was founded to standardize serology in
rheumatic diseases by preparing standard sera. Recently, RELARES
has been combined with SKML. A new SKMLworking group,
Standardization Autoimmune Serology, has been initiated to
continue the work of RELARES. When comparing the already
available Dutch initiatives to the international EASI goals,
there appears to be a lack of harmonization in testing
algorithms, and this issue is the most important topic to be
addressed in the near future.
Impact
This publication is mainly an overview of the network of
distinct organisations, including the Dutch EASI-team, working
in the field of autoimmune diagnostics. Since there is
substantial overlap in the people involved, there is optimal
collaboration in order to achieve the goals of EASI.
Damoiseaux J, Bakker-Jonges L,
Cohen Tervaert JW, Derksen R, Hooijkaas H, Kallenberg C,
Klasen I, Limburg P, Smeenk R, and Hamann D (2010).
Laboratoriumdiagnostiek van ANA, anti-ds-DNA- en
anti-ENA-antistoffen: aanbevelingen naar aanleiding van een
enquête. Ned Tijdschr Klin Chem Labgeneesk 2010;35:234-239.
(in Dutch)
Abstract
To gain insight in the laboratory diagnostics of auto-antibodies
to nuclear antigens (ANA, anti-dsDNA- and anti-ENA-anti¬bodies),
the Dutch EASI-team has prepared a questionnaire in
collaboration with SKML. This questionnaire has been distributed
to all participants of the external quality assessment program
for these auto-antibodies, as organized by SKML. Due to the high
response (87%), the Dutch situation has been very well
documented. The results are summarized in this paper and, in
addition, recommendations of the Dutch EASI-team are given.
Although these recommendations are not to be used as official
guidelines, they may harmonize and improve the detection of
auto-antibodies to nuclear antigens.
Impact
The questionnaire has been translated in English and has been
used by many other national EASI-teams. This has resulted in
national publications in other countries (Van Blerk et al. Acta
Clin Belgica 2014;69:83-86) as well as in an overview of the
European situation as far as countries have participated
(Damoiseaux et al, Clin Exp Rheum 2014;32:539-546). In
collaboration with the International Society for Immunological
Societies (IUIS) a set of recommendations have been published
(Agmon-Levin et al, Ann Rheum Dis 2014;73:17-23).
Molen RG van der, Roozendaal C,
and Damoiseaux J. Detectie van ANCA in Nederlandse
laboratoria: de klinische praktijk in relatie tot de
internationale consensus en nationale richtlijn. Ned Tijdschr
Klin Chem Labgeneesk 2014;39:19-24. (in Dutch)
Abstract
To gain insight in the laboratory diagnostics performed in the
Netherlands for anti-neutrophil cytoplasmic antibody (ANCA), a
questionnaire was sent to all Dutch diagnostic laboratories
(n=50) who participate in the Dutch quality assessment (SKML)
ANCA-GBM program. Due to the high response (86%), the Dutch
situation has been very well documented. The results are
summarized in this paper and compared to the International
Consensus Statement on Testing and Reporting of ANCA (1999) and
the Dutch CBO guidelines on small vessel vasculitis (2010).
Major conclusions resulting from the questionnaire are that
international and national guidelines are not consequently
applied by all labs. However, it should be noted that with the
development of new test systems, current guidelines need
revision.
Impact
The questionnaire has been translated in English and has been
used by many other national EASI-teams. This has resulted in an
overview of the European situation as far as countries have
participated (Damoiseaux et al, Clin Chem Lab Med 2018; in
press).
Damoiseaux J, Bossuyt X,
Broeders S, Hamann D, Leeuw K de, Limper M, Otten H,
Roozendaal C, Schouwers S, Schreurs M, Thurlings R, Daele P
van, Molen R van der, Van Hoovels L, Vercammen M, Bonroy C.
International Consensus on ANA Patterns (ICAP): inbedding in
het Nederlandse taalgebied. Laboratoriumgeneeskunde
2018;1:17-26. (in Dutch)
Abstract
In order to establish harmonization in reporting results of
autoimmune diagnostics, just a few years ago international
consensus was reached about the nomenclature and definitions of
HEp-2 patterns obtained by indirect immunofluorescence (IIF).
This test is applied to detect anticellular antibodies that are
generally reported as anti-nuclear antibodies (ANA). These
antibodies play a crucial role in the diagnostic work-up of
systemic autoimmune rheumatic diseases. In close collaboration
between the Belgian and Dutch EASI-teams the consensus is made
available for the Dutch-speaking areas. Starting point is the
widespread use of the Dutch names for the distinct HEp-2
patterns in both the Dutch and Flemish clinical laboratories.
Impact
Translation of the ICAP nomenclature and pattern definitions
enables harmonization of the reporting of test results.
Importantly, also the external quality assessment as organized
by the SKML currently ask for reporting according to ICAP
nomenclature. The translation has come accross in close
collaboration with the Belgian EASI-team.
Mulder L, Molen R van der,
Koelman C, Leeuwen E van, Roos A, Damoiseaux J. Validation
conform ISO-15189 of assays in the field of autoimmunity:
joint efforts in The Netherlands. Autoimmun Rev
2018;17:513-517.
Abstract
ISO 15189:2012 requires validation of methods used in the
medical laboratories, and lists a series of performance
parameters for consideration to include. Although these
performance parameters are feasible for clinical chemistry
analytes, application in the validation of autoimmunity tests is
a challenge. Lack of gold standards or reference methods in
combination with the scarcity of well-defined diagnostic samples
of patients with rare diseases make validation of new assays
difficult. The present manuscript describes the initiative of
Dutch medical immunology laboratory specialists to combine
efforts and perform multi-center validation studies of new
assays in the field of autoimmunity. Validation data and reports
are made available to interested Dutch laboratory specialists.
Impact
Since the introduction of this initiative several assays have
been validated according to the proposed algorithm. Although
this is not an EASI-initiative, the proposed algorithm can
easily be used by EASI-teams in other countries and this is also
in accordance with a possible role of EASI in assisting
laboratories in the process of accreditation (Bizzaro et al.
Autoimmun Rev 2017;16-81-86).
Current
Activities:
A follow-up questionnaire has been
distributed about the ANA-dsDNA-ENA algorithm that is currently
being used in the Dutch autoimmune laboratories. The goal is to
find out if laboratories adhere to the Dutch recommendations. If
laboratories follow the recommendation it is asked if this is
the result of an adjustment; if laboratories do not adhere to
the recommendation it is asked to give an argument. The
responses are currently being analysed and the expectation is
that the recommendations might be slightly adjusted and be
included in a national guideline.
The Dutch EASI-team participates in the project of the Belgian
EASI-team to explore how ICAP is anticipated on the one hand by
laboratory specialists and on the other hand by rheumatologists
and clinical immunologists. Results will eventually be analysed
by the Belgian EASI-team.