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Development and evaluation of a secondary reference panel for BCR-ABL1 quantification on the International Scale

Identifieur interne : 002107 ( Main/Exploration ); précédent : 002106; suivant : 002108

Development and evaluation of a secondary reference panel for BCR-ABL1 quantification on the International Scale

Auteurs : N C P. Cross [Royaume-Uni] ; H E White [Royaume-Uni] ; T. Ernst [Allemagne] ; L. Welden [Australie] ; C. Dietz [Allemagne] ; G. Saglio [Italie] ; F-X Mahon [France] ; C C Wong [États-Unis] ; D. Zheng [États-Unis] ; S. Wong [États-Unis] ; S-S Wang [États-Unis] ; S. Akiki [Royaume-Uni] ; F. Albano [Italie] ; H. Andrikovics [Hongrie] ; J. Anwar [Royaume-Uni] ; G. Balatzenko [Bulgarie] ; I. Bendit [Brésil] ; J. Beveridge [Australie] ; N. Boeckx [Belgique] ; N. Cerveira [Portugal] ; S-M Cheng [États-Unis] ; D. Colomer [Espagne] ; S. Czurda [Autriche] ; F. Daraio [Italie] ; S. Dulucq [France] ; L. Eggen [Norvège] ; H. El Housni [Belgique] ; G. Gerrard [Royaume-Uni] ; M. Gniot [Pologne] ; B. Izzo [Italie] ; D. Jacquin [États-Unis] ; J J W M. Janssen [Pays-Bas] ; S. Jeromin [Allemagne] ; T. Jurcek [République tchèque] ; D-W Kim [Corée du Sud] ; K. Machova-Polakova [République tchèque] ; J. Martinez-Lopez [Espagne] ; M. Mcbean [Australie] ; S. Mesanovic [Bosnie-Herzégovine] ; G. Mitterbauer-Hohendanner [Autriche] ; H. Mobtaker [États-Unis] ; M-J Mozziconacci [France] ; T. Paji [Slovénie] ; N. Pallisgaard [Danemark] ; P. Panagiotidis [Grèce] ; R D Press [États-Unis] ; Y-Z Qin [République populaire de Chine] ; J. Radich [États-Unis] ; T. Sacha [Pologne] ; T. Touloumenidou [Grèce] ; P. Waits [Royaume-Uni] ; E. Wilkinson [Royaume-Uni] ; R. Zadro [Croatie] ; M C Müller [Allemagne] ; A. Hochhaus [Allemagne] ; S. Branford [Australie]

Source :

RBID : PMC:5240017

Descripteurs français

English descriptors

Abstract

Molecular monitoring of chronic myeloid leukemia patients using robust BCR-ABL1 tests standardized to the International Scale (IS) is key to proper disease management, especially when treatment cessation is considered. Most laboratories currently use a time-consuming sample exchange process with reference laboratories for IS calibration. A World Health Organization (WHO) BCR-ABL1 reference panel was developed (MR1–MR4), but access to the material is limited. In this study, we describe the development of the first cell-based secondary reference panel that is traceable to and faithfully replicates the WHO panel, with an additional MR4.5 level. The secondary panel was calibrated to IS using digital PCR with ABL1, BCR and GUSB as reference genes and evaluated by 44 laboratories worldwide. Interestingly, we found that >40% of BCR-ABL1 assays showed signs of inadequate optimization such as poor linearity and suboptimal PCR efficiency. Nonetheless, when optimized sample inputs were used, >60% demonstrated satisfactory IS accuracy, precision and/or MR4.5 sensitivity, and 58% obtained IS conversion factors from the secondary reference concordant with their current values. Correlation analysis indicated no significant alterations in %BCR-ABL1 results caused by different assay configurations. More assays achieved good precision and/or sensitivity than IS accuracy, indicating the need for better IS calibration mechanisms.


Url:
DOI: 10.1038/leu.2016.90
PubMed: 27109508
PubMed Central: 5240017


Affiliations:


Links toward previous steps (curation, corpus...)


Le document en format XML

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<institution>Bergonie Institute Cancer Center Bordeaux, INSERM U1218, University of Bordeaux</institution>
, Bordeaux,
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<country xml:lang="fr">France</country>
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<name sortKey="Wong, C C" sort="Wong, C C" uniqKey="Wong C" first="C C" last="Wong">C C Wong</name>
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<institution>Novartis Pharmaceuticals Corporation</institution>
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<country xml:lang="fr">États-Unis</country>
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<name sortKey="Zheng, D" sort="Zheng, D" uniqKey="Zheng D" first="D" last="Zheng">D. Zheng</name>
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<name sortKey="Wong, S" sort="Wong, S" uniqKey="Wong S" first="S" last="Wong">S. Wong</name>
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<name sortKey="Wang, S S" sort="Wang, S S" uniqKey="Wang S" first="S-S" last="Wang">S-S Wang</name>
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<nlm:aff id="aff8">
<institution>Novartis Pharmaceuticals Corporation</institution>
, East Hanover, NJ,
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<country xml:lang="fr">États-Unis</country>
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<name sortKey="Akiki, S" sort="Akiki, S" uniqKey="Akiki S" first="S" last="Akiki">S. Akiki</name>
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<nlm:aff id="aff9">
<institution>West Midlands Regional Genetics Laboratory</institution>
, Birmingham,
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<country xml:lang="fr">Royaume-Uni</country>
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<name sortKey="Albano, F" sort="Albano, F" uniqKey="Albano F" first="F" last="Albano">F. Albano</name>
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<nlm:aff id="aff10">
<institution>Department of Hematology, University of Bari</institution>
, Bari,
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<country xml:lang="fr">Italie</country>
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<institution>Laboratory of Molecular Diagnostics, Hungarian National Blood Transfusion Service</institution>
, Budapest,
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</nlm:aff>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<affiliation wicri:level="1">
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<institution>Department of Pathophysiology, Semmelweis University</institution>
, Budapest,
<country>Hungary</country>
</nlm:aff>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Anwar, J" sort="Anwar, J" uniqKey="Anwar J" first="J" last="Anwar">J. Anwar</name>
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<institution>King's College Hospital London</institution>
, London,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Balatzenko, G" sort="Balatzenko, G" uniqKey="Balatzenko G" first="G" last="Balatzenko">G. Balatzenko</name>
<affiliation wicri:level="1">
<nlm:aff id="aff14">
<institution>National Specialized Hospital for Active Treatment of Hematological Diseases</institution>
, Sofia,
<country>Bulgaria</country>
</nlm:aff>
<country xml:lang="fr">Bulgarie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author>
<name sortKey="Bendit, I" sort="Bendit, I" uniqKey="Bendit I" first="I" last="Bendit">I. Bendit</name>
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<institution>Laboratorio de Biologia Tumoral, Disciplina de Hematologia do HC-FMUSP</institution>
, São Paulo,
<country>Brazil</country>
</nlm:aff>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Beveridge, J" sort="Beveridge, J" uniqKey="Beveridge J" first="J" last="Beveridge">J. Beveridge</name>
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<institution>PathWest Laboratory Medicine WA, Department of Haematology, Fiona Stanley Hospital</institution>
, Perth, WA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Boeckx, N" sort="Boeckx, N" uniqKey="Boeckx N" first="N" last="Boeckx">N. Boeckx</name>
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<institution>Department of Laboratory Medicine, University Hospitals Leuven</institution>
, Leuven,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff18">
<institution>Department of Oncology, KUL</institution>
, Leuven,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author>
<name sortKey="Cerveira, N" sort="Cerveira, N" uniqKey="Cerveira N" first="N" last="Cerveira">N. Cerveira</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Department of Genetics, Portuguese Oncology Institute</institution>
, Porto,
<country>Portugal</country>
</nlm:aff>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Cheng, S M" sort="Cheng, S M" uniqKey="Cheng S" first="S-M" last="Cheng">S-M Cheng</name>
<affiliation wicri:level="1">
<nlm:aff id="aff20">
<institution>Department of Hematology and Oncology, Quest Diagnostics Nichols Institute</institution>
, San Juan Capistrano, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author>
<name sortKey="Colomer, D" sort="Colomer, D" uniqKey="Colomer D" first="D" last="Colomer">D. Colomer</name>
<affiliation wicri:level="1">
<nlm:aff id="aff21">
<institution>Hematopathology Unit, Hospital Clinic, IDIBAPS</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Czurda, S" sort="Czurda, S" uniqKey="Czurda S" first="S" last="Czurda">S. Czurda</name>
<affiliation wicri:level="1">
<nlm:aff id="aff22">
<institution>Division of Molecular Microbiology, Children's Cancer Research Institute</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Daraio, F" sort="Daraio, F" uniqKey="Daraio F" first="F" last="Daraio">F. Daraio</name>
<affiliation wicri:level="1">
<nlm:aff id="aff23">
<institution>Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin</institution>
, Orbassano,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dulucq, S" sort="Dulucq, S" uniqKey="Dulucq S" first="S" last="Dulucq">S. Dulucq</name>
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<nlm:aff id="aff24">
<institution>Laboratoire Hematologie, Centre Hospitalier Universitaire de Bordeaux, Universite Bordeaux</institution>
, Bordeaux,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Eggen, L" sort="Eggen, L" uniqKey="Eggen L" first="L" last="Eggen">L. Eggen</name>
<affiliation wicri:level="1">
<nlm:aff id="aff25">
<institution>Laboratory of Molecular Pathology, Oslo University Hospital</institution>
, Oslo,
<country>Norway</country>
</nlm:aff>
<country xml:lang="fr">Norvège</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="El Housni, H" sort="El Housni, H" uniqKey="El Housni H" first="H" last="El Housni">H. El Housni</name>
<affiliation wicri:level="1">
<nlm:aff id="aff26">
<institution>Clinique de Genetique Oncologique-Service de genetique, Hopital Erasme</institution>
, Brussels,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Gerrard, G" sort="Gerrard, G" uniqKey="Gerrard G" first="G" last="Gerrard">G. Gerrard</name>
<affiliation wicri:level="1">
<nlm:aff id="aff27">
<institution>Imperial Molecular Pathology, Hammersmith Hospital</institution>
, London,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Gniot, M" sort="Gniot, M" uniqKey="Gniot M" first="M" last="Gniot">M. Gniot</name>
<affiliation wicri:level="1">
<nlm:aff id="aff28">
<institution>Department of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences</institution>
, Poznan,
<country>Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Izzo, B" sort="Izzo, B" uniqKey="Izzo B" first="B" last="Izzo">B. Izzo</name>
<affiliation wicri:level="1">
<nlm:aff id="aff29">
<institution>Department of Clinical Medicine and Surgery, University ‘Federico II' of Naples</institution>
, Naples,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff30">
<institution>CEINGE – Biotecnologie Avanzate</institution>
, Naples,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Jacquin, D" sort="Jacquin, D" uniqKey="Jacquin D" first="D" last="Jacquin">D. Jacquin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff31">
<institution>Genoptix, Inc.</institution>
, Carlsbad, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Janssen, J J W M" sort="Janssen, J J W M" uniqKey="Janssen J" first="J J W M" last="Janssen">J J W M. Janssen</name>
<affiliation wicri:level="1">
<nlm:aff id="aff32">
<institution>Department of Hematology and Molecular Diagnostics, VU University Medical Center</institution>
, Amsterdam,
<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jeromin, S" sort="Jeromin, S" uniqKey="Jeromin S" first="S" last="Jeromin">S. Jeromin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff33">
<institution>MLL Munich Leukemia Laboratory</institution>
, Munich,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jurcek, T" sort="Jurcek, T" uniqKey="Jurcek T" first="T" last="Jurcek">T. Jurcek</name>
<affiliation wicri:level="1">
<nlm:aff id="aff34">
<institution>Center of Molecular Biology and Gene Therapy, Department of Internal Medicine-Hematology and Oncology, Masaryk University and University Hospital Brno</institution>
, Brno,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name>
<affiliation wicri:level="1">
<nlm:aff id="aff35">
<institution>Seoul St Mary's Hospital, Leukemia Research Institute, The Catholic University of Korea</institution>
, Seoul,
<country>Korea</country>
</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Machova Polakova, K" sort="Machova Polakova, K" uniqKey="Machova Polakova K" first="K" last="Machova-Polakova">K. Machova-Polakova</name>
<affiliation wicri:level="1">
<nlm:aff id="aff36">
<institution>Department of Molecular Genetics, Institute of Hematology and Blood Transfusion</institution>
, Prague,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Martinez Lopez, J" sort="Martinez Lopez, J" uniqKey="Martinez Lopez J" first="J" last="Martinez-Lopez">J. Martinez-Lopez</name>
<affiliation wicri:level="1">
<nlm:aff id="aff37">
<institution>Department of Hematology, Hospital Universitario 12 de Octubre, Universidad Complutense, CNIO</institution>
, Madrid,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mcbean, M" sort="Mcbean, M" uniqKey="Mcbean M" first="M" last="Mcbean">M. Mcbean</name>
<affiliation wicri:level="1">
<nlm:aff id="aff38">
<institution>Division of Cancer Medicine, Department of Pathology, Peter MacCallum Cancer Centre</institution>
, East Melbourne, VIC,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mesanovic, S" sort="Mesanovic, S" uniqKey="Mesanovic S" first="S" last="Mesanovic">S. Mesanovic</name>
<affiliation wicri:level="1">
<nlm:aff id="aff39">
<institution>Pathology Department, University Clinical Center Tuzla</institution>
, Tuzla,
<country>Bosnia and Herzegovina</country>
</nlm:aff>
<country xml:lang="fr">Bosnie-Herzégovine</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mitterbauer Hohendanner, G" sort="Mitterbauer Hohendanner, G" uniqKey="Mitterbauer Hohendanner G" first="G" last="Mitterbauer-Hohendanner">G. Mitterbauer-Hohendanner</name>
<affiliation wicri:level="1">
<nlm:aff id="aff40">
<institution>Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mobtaker, H" sort="Mobtaker, H" uniqKey="Mobtaker H" first="H" last="Mobtaker">H. Mobtaker</name>
<affiliation wicri:level="1">
<nlm:aff id="aff31">
<institution>Genoptix, Inc.</institution>
, Carlsbad, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mozziconacci, M J" sort="Mozziconacci, M J" uniqKey="Mozziconacci M" first="M-J" last="Mozziconacci">M-J Mozziconacci</name>
<affiliation wicri:level="1">
<nlm:aff id="aff41">
<institution>Departement de Biopathologie, Institut Paoli-Calmettes</institution>
, Marseille,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Paji, T" sort="Paji, T" uniqKey="Paji T" first="T" last="Paji">T. Paji</name>
<affiliation wicri:level="1">
<nlm:aff id="aff42">
<institution>Specialized Haematology Laboratory, Department of Haematology, University Medical Centre Ljubljana</institution>
, Ljubljana,
<country>Slovenia</country>
</nlm:aff>
<country xml:lang="fr">Slovénie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pallisgaard, N" sort="Pallisgaard, N" uniqKey="Pallisgaard N" first="N" last="Pallisgaard">N. Pallisgaard</name>
<affiliation wicri:level="1">
<nlm:aff id="aff43">
<institution>Department of Surgical Pathology, Zealand University Hospital</institution>
, Roskilde,
<country>Denmark</country>
</nlm:aff>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Panagiotidis, P" sort="Panagiotidis, P" uniqKey="Panagiotidis P" first="P" last="Panagiotidis">P. Panagiotidis</name>
<affiliation wicri:level="1">
<nlm:aff id="aff44">
<institution>Hematology Unit, First Department of Internal Medicine, Laiko Hospital, University of Athens,</institution>
Athens,
<country>Greece</country>
</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Press, R D" sort="Press, R D" uniqKey="Press R" first="R D" last="Press">R D Press</name>
<affiliation wicri:level="1">
<nlm:aff id="aff45">
<institution>Department of Pathology and Knight Cancer Institute, Oregon Health and Science University</institution>
, Portland, OR,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Qin, Y Z" sort="Qin, Y Z" uniqKey="Qin Y" first="Y-Z" last="Qin">Y-Z Qin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff46">
<institution>Peking University People's Hospital, Peking University Institute of Hematology</institution>
, Beijing,
<country>China</country>
</nlm:aff>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Radich, J" sort="Radich, J" uniqKey="Radich J" first="J" last="Radich">J. Radich</name>
<affiliation wicri:level="1">
<nlm:aff id="aff47">
<institution>Fred Hutchinson Cancer Research Center</institution>
, Seattle, WA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Sacha, T" sort="Sacha, T" uniqKey="Sacha T" first="T" last="Sacha">T. Sacha</name>
<affiliation wicri:level="1">
<nlm:aff id="aff48">
<institution>Chair and Department of Hematology, Jagiellonian University</institution>
, Kraków,
<country>Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Touloumenidou, T" sort="Touloumenidou, T" uniqKey="Touloumenidou T" first="T" last="Touloumenidou">T. Touloumenidou</name>
<affiliation wicri:level="1">
<nlm:aff id="aff49">
<institution>Laboratory of Molecular Biology, Hematology Department and HCT Unit, G. Papanicolaou Hospital</institution>
, Thessaloniki,
<country>Greece</country>
</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Waits, P" sort="Waits, P" uniqKey="Waits P" first="P" last="Waits">P. Waits</name>
<affiliation wicri:level="1">
<nlm:aff id="aff50">
<institution>Bristol Genetics Laboratory</institution>
, Bristol,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wilkinson, E" sort="Wilkinson, E" uniqKey="Wilkinson E" first="E" last="Wilkinson">E. Wilkinson</name>
<affiliation wicri:level="1">
<nlm:aff id="aff51">
<institution>HMDS, Leeds Teaching Hospitals</institution>
, Leeds,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Zadro, R" sort="Zadro, R" uniqKey="Zadro R" first="R" last="Zadro">R. Zadro</name>
<affiliation wicri:level="1">
<nlm:aff id="aff52">
<institution>Faculty of Pharmacy and Biochemistry and University Hospital Center Zagreb, University of Zagreb</institution>
, Zagreb,
<country>Croatia</country>
</nlm:aff>
<country xml:lang="fr">Croatie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Muller, M C" sort="Muller, M C" uniqKey="Muller M" first="M C" last="Müller">M C Müller</name>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg</institution>
, Mannheim,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name>
<affiliation wicri:level="1">
<nlm:aff id="aff3">
<institution>Department of Hematology/Oncology, Universitätsklinikum Jena</institution>
, Jena,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Branford, S" sort="Branford, S" uniqKey="Branford S" first="S" last="Branford">S. Branford</name>
<affiliation wicri:level="1">
<nlm:aff id="aff4">
<institution>Department of Genetics and Molecular Pathology, Centre for Cancer Biology, SA Pathology</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff53">
<institution>School of Pharmacy and Medical Science, University of South Australia</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff54">
<institution>School of Medicine, University of Adelaide</institution>
, SA, Adelaide,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff55">
<institution>School of Molecular and Biomedical Science, University of Adelaide</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">PMC</idno>
<idno type="pmid">27109508</idno>
<idno type="pmc">5240017</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240017</idno>
<idno type="RBID">PMC:5240017</idno>
<idno type="doi">10.1038/leu.2016.90</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">000727</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000727</idno>
<idno type="wicri:Area/Pmc/Curation">000726</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000726</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000A21</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000A21</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="wicri:Area/PubMed/Corpus">001995</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001995</idno>
<idno type="wicri:Area/PubMed/Curation">001971</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001971</idno>
<idno type="wicri:Area/PubMed/Checkpoint">001971</idno>
<idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001971</idno>
<idno type="wicri:Area/Ncbi/Merge">003459</idno>
<idno type="wicri:Area/Ncbi/Curation">003459</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">003459</idno>
<idno type="wicri:doubleKey">0887-6924:2016:Cross N:development:and:evaluation</idno>
<idno type="wicri:Area/Main/Merge">002106</idno>
<idno type="wicri:Area/Main/Curation">002107</idno>
<idno type="wicri:Area/Main/Exploration">002107</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title xml:lang="en" level="a" type="main">Development and evaluation of a secondary reference panel for
<italic>BCR-ABL1</italic>
quantification on the International Scale</title>
<author>
<name sortKey="Cross, N C P" sort="Cross, N C P" uniqKey="Cross N" first="N C P" last="Cross">N C P. Cross</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Wessex Regional Genetics Laboratory, Salisbury NHS Foundation Trust</institution>
, Salisbury,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>Faculty of Medicine, University of Southampton</institution>
, Southampton,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="White, H E" sort="White, H E" uniqKey="White H" first="H E" last="White">H E White</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Wessex Regional Genetics Laboratory, Salisbury NHS Foundation Trust</institution>
, Salisbury,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>Faculty of Medicine, University of Southampton</institution>
, Southampton,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ernst, T" sort="Ernst, T" uniqKey="Ernst T" first="T" last="Ernst">T. Ernst</name>
<affiliation wicri:level="1">
<nlm:aff id="aff3">
<institution>Department of Hematology/Oncology, Universitätsklinikum Jena</institution>
, Jena,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Welden, L" sort="Welden, L" uniqKey="Welden L" first="L" last="Welden">L. Welden</name>
<affiliation wicri:level="1">
<nlm:aff id="aff4">
<institution>Department of Genetics and Molecular Pathology, Centre for Cancer Biology, SA Pathology</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dietz, C" sort="Dietz, C" uniqKey="Dietz C" first="C" last="Dietz">C. Dietz</name>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg</institution>
, Mannheim,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name>
<affiliation wicri:level="1">
<nlm:aff id="aff6">
<institution>Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin</institution>
, Orbassano,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mahon, F X" sort="Mahon, F X" uniqKey="Mahon F" first="F-X" last="Mahon">F-X Mahon</name>
<affiliation wicri:level="1">
<nlm:aff id="aff7">
<institution>Bergonie Institute Cancer Center Bordeaux, INSERM U1218, University of Bordeaux</institution>
, Bordeaux,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wong, C C" sort="Wong, C C" uniqKey="Wong C" first="C C" last="Wong">C C Wong</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>Novartis Pharmaceuticals Corporation</institution>
, East Hanover, NJ,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Zheng, D" sort="Zheng, D" uniqKey="Zheng D" first="D" last="Zheng">D. Zheng</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>Novartis Pharmaceuticals Corporation</institution>
, East Hanover, NJ,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wong, S" sort="Wong, S" uniqKey="Wong S" first="S" last="Wong">S. Wong</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>Novartis Pharmaceuticals Corporation</institution>
, East Hanover, NJ,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wang, S S" sort="Wang, S S" uniqKey="Wang S" first="S-S" last="Wang">S-S Wang</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>Novartis Pharmaceuticals Corporation</institution>
, East Hanover, NJ,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Akiki, S" sort="Akiki, S" uniqKey="Akiki S" first="S" last="Akiki">S. Akiki</name>
<affiliation wicri:level="1">
<nlm:aff id="aff9">
<institution>West Midlands Regional Genetics Laboratory</institution>
, Birmingham,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Albano, F" sort="Albano, F" uniqKey="Albano F" first="F" last="Albano">F. Albano</name>
<affiliation wicri:level="1">
<nlm:aff id="aff10">
<institution>Department of Hematology, University of Bari</institution>
, Bari,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Andrikovics, H" sort="Andrikovics, H" uniqKey="Andrikovics H" first="H" last="Andrikovics">H. Andrikovics</name>
<affiliation wicri:level="1">
<nlm:aff id="aff11">
<institution>Laboratory of Molecular Diagnostics, Hungarian National Blood Transfusion Service</institution>
, Budapest,
<country>Hungary</country>
</nlm:aff>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff12">
<institution>Department of Pathophysiology, Semmelweis University</institution>
, Budapest,
<country>Hungary</country>
</nlm:aff>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Anwar, J" sort="Anwar, J" uniqKey="Anwar J" first="J" last="Anwar">J. Anwar</name>
<affiliation wicri:level="1">
<nlm:aff id="aff13">
<institution>King's College Hospital London</institution>
, London,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Balatzenko, G" sort="Balatzenko, G" uniqKey="Balatzenko G" first="G" last="Balatzenko">G. Balatzenko</name>
<affiliation wicri:level="1">
<nlm:aff id="aff14">
<institution>National Specialized Hospital for Active Treatment of Hematological Diseases</institution>
, Sofia,
<country>Bulgaria</country>
</nlm:aff>
<country xml:lang="fr">Bulgarie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Bendit, I" sort="Bendit, I" uniqKey="Bendit I" first="I" last="Bendit">I. Bendit</name>
<affiliation wicri:level="1">
<nlm:aff id="aff15">
<institution>Laboratorio de Biologia Tumoral, Disciplina de Hematologia do HC-FMUSP</institution>
, São Paulo,
<country>Brazil</country>
</nlm:aff>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Beveridge, J" sort="Beveridge, J" uniqKey="Beveridge J" first="J" last="Beveridge">J. Beveridge</name>
<affiliation wicri:level="1">
<nlm:aff id="aff16">
<institution>PathWest Laboratory Medicine WA, Department of Haematology, Fiona Stanley Hospital</institution>
, Perth, WA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Boeckx, N" sort="Boeckx, N" uniqKey="Boeckx N" first="N" last="Boeckx">N. Boeckx</name>
<affiliation wicri:level="1">
<nlm:aff id="aff17">
<institution>Department of Laboratory Medicine, University Hospitals Leuven</institution>
, Leuven,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff18">
<institution>Department of Oncology, KUL</institution>
, Leuven,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Cerveira, N" sort="Cerveira, N" uniqKey="Cerveira N" first="N" last="Cerveira">N. Cerveira</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Department of Genetics, Portuguese Oncology Institute</institution>
, Porto,
<country>Portugal</country>
</nlm:aff>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Cheng, S M" sort="Cheng, S M" uniqKey="Cheng S" first="S-M" last="Cheng">S-M Cheng</name>
<affiliation wicri:level="1">
<nlm:aff id="aff20">
<institution>Department of Hematology and Oncology, Quest Diagnostics Nichols Institute</institution>
, San Juan Capistrano, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Colomer, D" sort="Colomer, D" uniqKey="Colomer D" first="D" last="Colomer">D. Colomer</name>
<affiliation wicri:level="1">
<nlm:aff id="aff21">
<institution>Hematopathology Unit, Hospital Clinic, IDIBAPS</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Czurda, S" sort="Czurda, S" uniqKey="Czurda S" first="S" last="Czurda">S. Czurda</name>
<affiliation wicri:level="1">
<nlm:aff id="aff22">
<institution>Division of Molecular Microbiology, Children's Cancer Research Institute</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Daraio, F" sort="Daraio, F" uniqKey="Daraio F" first="F" last="Daraio">F. Daraio</name>
<affiliation wicri:level="1">
<nlm:aff id="aff23">
<institution>Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin</institution>
, Orbassano,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dulucq, S" sort="Dulucq, S" uniqKey="Dulucq S" first="S" last="Dulucq">S. Dulucq</name>
<affiliation wicri:level="1">
<nlm:aff id="aff24">
<institution>Laboratoire Hematologie, Centre Hospitalier Universitaire de Bordeaux, Universite Bordeaux</institution>
, Bordeaux,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Eggen, L" sort="Eggen, L" uniqKey="Eggen L" first="L" last="Eggen">L. Eggen</name>
<affiliation wicri:level="1">
<nlm:aff id="aff25">
<institution>Laboratory of Molecular Pathology, Oslo University Hospital</institution>
, Oslo,
<country>Norway</country>
</nlm:aff>
<country xml:lang="fr">Norvège</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="El Housni, H" sort="El Housni, H" uniqKey="El Housni H" first="H" last="El Housni">H. El Housni</name>
<affiliation wicri:level="1">
<nlm:aff id="aff26">
<institution>Clinique de Genetique Oncologique-Service de genetique, Hopital Erasme</institution>
, Brussels,
<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Gerrard, G" sort="Gerrard, G" uniqKey="Gerrard G" first="G" last="Gerrard">G. Gerrard</name>
<affiliation wicri:level="1">
<nlm:aff id="aff27">
<institution>Imperial Molecular Pathology, Hammersmith Hospital</institution>
, London,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Gniot, M" sort="Gniot, M" uniqKey="Gniot M" first="M" last="Gniot">M. Gniot</name>
<affiliation wicri:level="1">
<nlm:aff id="aff28">
<institution>Department of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences</institution>
, Poznan,
<country>Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Izzo, B" sort="Izzo, B" uniqKey="Izzo B" first="B" last="Izzo">B. Izzo</name>
<affiliation wicri:level="1">
<nlm:aff id="aff29">
<institution>Department of Clinical Medicine and Surgery, University ‘Federico II' of Naples</institution>
, Naples,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff30">
<institution>CEINGE – Biotecnologie Avanzate</institution>
, Naples,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jacquin, D" sort="Jacquin, D" uniqKey="Jacquin D" first="D" last="Jacquin">D. Jacquin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff31">
<institution>Genoptix, Inc.</institution>
, Carlsbad, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Janssen, J J W M" sort="Janssen, J J W M" uniqKey="Janssen J" first="J J W M" last="Janssen">J J W M. Janssen</name>
<affiliation wicri:level="1">
<nlm:aff id="aff32">
<institution>Department of Hematology and Molecular Diagnostics, VU University Medical Center</institution>
, Amsterdam,
<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jeromin, S" sort="Jeromin, S" uniqKey="Jeromin S" first="S" last="Jeromin">S. Jeromin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff33">
<institution>MLL Munich Leukemia Laboratory</institution>
, Munich,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jurcek, T" sort="Jurcek, T" uniqKey="Jurcek T" first="T" last="Jurcek">T. Jurcek</name>
<affiliation wicri:level="1">
<nlm:aff id="aff34">
<institution>Center of Molecular Biology and Gene Therapy, Department of Internal Medicine-Hematology and Oncology, Masaryk University and University Hospital Brno</institution>
, Brno,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name>
<affiliation wicri:level="1">
<nlm:aff id="aff35">
<institution>Seoul St Mary's Hospital, Leukemia Research Institute, The Catholic University of Korea</institution>
, Seoul,
<country>Korea</country>
</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Machova Polakova, K" sort="Machova Polakova, K" uniqKey="Machova Polakova K" first="K" last="Machova-Polakova">K. Machova-Polakova</name>
<affiliation wicri:level="1">
<nlm:aff id="aff36">
<institution>Department of Molecular Genetics, Institute of Hematology and Blood Transfusion</institution>
, Prague,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Martinez Lopez, J" sort="Martinez Lopez, J" uniqKey="Martinez Lopez J" first="J" last="Martinez-Lopez">J. Martinez-Lopez</name>
<affiliation wicri:level="1">
<nlm:aff id="aff37">
<institution>Department of Hematology, Hospital Universitario 12 de Octubre, Universidad Complutense, CNIO</institution>
, Madrid,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mcbean, M" sort="Mcbean, M" uniqKey="Mcbean M" first="M" last="Mcbean">M. Mcbean</name>
<affiliation wicri:level="1">
<nlm:aff id="aff38">
<institution>Division of Cancer Medicine, Department of Pathology, Peter MacCallum Cancer Centre</institution>
, East Melbourne, VIC,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mesanovic, S" sort="Mesanovic, S" uniqKey="Mesanovic S" first="S" last="Mesanovic">S. Mesanovic</name>
<affiliation wicri:level="1">
<nlm:aff id="aff39">
<institution>Pathology Department, University Clinical Center Tuzla</institution>
, Tuzla,
<country>Bosnia and Herzegovina</country>
</nlm:aff>
<country xml:lang="fr">Bosnie-Herzégovine</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mitterbauer Hohendanner, G" sort="Mitterbauer Hohendanner, G" uniqKey="Mitterbauer Hohendanner G" first="G" last="Mitterbauer-Hohendanner">G. Mitterbauer-Hohendanner</name>
<affiliation wicri:level="1">
<nlm:aff id="aff40">
<institution>Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mobtaker, H" sort="Mobtaker, H" uniqKey="Mobtaker H" first="H" last="Mobtaker">H. Mobtaker</name>
<affiliation wicri:level="1">
<nlm:aff id="aff31">
<institution>Genoptix, Inc.</institution>
, Carlsbad, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mozziconacci, M J" sort="Mozziconacci, M J" uniqKey="Mozziconacci M" first="M-J" last="Mozziconacci">M-J Mozziconacci</name>
<affiliation wicri:level="1">
<nlm:aff id="aff41">
<institution>Departement de Biopathologie, Institut Paoli-Calmettes</institution>
, Marseille,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Paji, T" sort="Paji, T" uniqKey="Paji T" first="T" last="Paji">T. Paji</name>
<affiliation wicri:level="1">
<nlm:aff id="aff42">
<institution>Specialized Haematology Laboratory, Department of Haematology, University Medical Centre Ljubljana</institution>
, Ljubljana,
<country>Slovenia</country>
</nlm:aff>
<country xml:lang="fr">Slovénie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pallisgaard, N" sort="Pallisgaard, N" uniqKey="Pallisgaard N" first="N" last="Pallisgaard">N. Pallisgaard</name>
<affiliation wicri:level="1">
<nlm:aff id="aff43">
<institution>Department of Surgical Pathology, Zealand University Hospital</institution>
, Roskilde,
<country>Denmark</country>
</nlm:aff>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Panagiotidis, P" sort="Panagiotidis, P" uniqKey="Panagiotidis P" first="P" last="Panagiotidis">P. Panagiotidis</name>
<affiliation wicri:level="1">
<nlm:aff id="aff44">
<institution>Hematology Unit, First Department of Internal Medicine, Laiko Hospital, University of Athens,</institution>
Athens,
<country>Greece</country>
</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Press, R D" sort="Press, R D" uniqKey="Press R" first="R D" last="Press">R D Press</name>
<affiliation wicri:level="1">
<nlm:aff id="aff45">
<institution>Department of Pathology and Knight Cancer Institute, Oregon Health and Science University</institution>
, Portland, OR,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Qin, Y Z" sort="Qin, Y Z" uniqKey="Qin Y" first="Y-Z" last="Qin">Y-Z Qin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff46">
<institution>Peking University People's Hospital, Peking University Institute of Hematology</institution>
, Beijing,
<country>China</country>
</nlm:aff>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Radich, J" sort="Radich, J" uniqKey="Radich J" first="J" last="Radich">J. Radich</name>
<affiliation wicri:level="1">
<nlm:aff id="aff47">
<institution>Fred Hutchinson Cancer Research Center</institution>
, Seattle, WA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Sacha, T" sort="Sacha, T" uniqKey="Sacha T" first="T" last="Sacha">T. Sacha</name>
<affiliation wicri:level="1">
<nlm:aff id="aff48">
<institution>Chair and Department of Hematology, Jagiellonian University</institution>
, Kraków,
<country>Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Touloumenidou, T" sort="Touloumenidou, T" uniqKey="Touloumenidou T" first="T" last="Touloumenidou">T. Touloumenidou</name>
<affiliation wicri:level="1">
<nlm:aff id="aff49">
<institution>Laboratory of Molecular Biology, Hematology Department and HCT Unit, G. Papanicolaou Hospital</institution>
, Thessaloniki,
<country>Greece</country>
</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Waits, P" sort="Waits, P" uniqKey="Waits P" first="P" last="Waits">P. Waits</name>
<affiliation wicri:level="1">
<nlm:aff id="aff50">
<institution>Bristol Genetics Laboratory</institution>
, Bristol,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wilkinson, E" sort="Wilkinson, E" uniqKey="Wilkinson E" first="E" last="Wilkinson">E. Wilkinson</name>
<affiliation wicri:level="1">
<nlm:aff id="aff51">
<institution>HMDS, Leeds Teaching Hospitals</institution>
, Leeds,
<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Zadro, R" sort="Zadro, R" uniqKey="Zadro R" first="R" last="Zadro">R. Zadro</name>
<affiliation wicri:level="1">
<nlm:aff id="aff52">
<institution>Faculty of Pharmacy and Biochemistry and University Hospital Center Zagreb, University of Zagreb</institution>
, Zagreb,
<country>Croatia</country>
</nlm:aff>
<country xml:lang="fr">Croatie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Muller, M C" sort="Muller, M C" uniqKey="Muller M" first="M C" last="Müller">M C Müller</name>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg</institution>
, Mannheim,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name>
<affiliation wicri:level="1">
<nlm:aff id="aff3">
<institution>Department of Hematology/Oncology, Universitätsklinikum Jena</institution>
, Jena,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Branford, S" sort="Branford, S" uniqKey="Branford S" first="S" last="Branford">S. Branford</name>
<affiliation wicri:level="1">
<nlm:aff id="aff4">
<institution>Department of Genetics and Molecular Pathology, Centre for Cancer Biology, SA Pathology</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff53">
<institution>School of Pharmacy and Medical Science, University of South Australia</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff54">
<institution>School of Medicine, University of Adelaide</institution>
, SA, Adelaide,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff55">
<institution>School of Molecular and Biomedical Science, University of Adelaide</institution>
, Adelaide, SA,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Leukemia</title>
<idno type="ISSN">0887-6924</idno>
<idno type="eISSN">1476-5551</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Calibration</term>
<term>Fusion Proteins, bcr-abl (analysis)</term>
<term>Fusion Proteins, bcr-abl (standards)</term>
<term>Genes, abl</term>
<term>Humans</term>
<term>Polymerase Chain Reaction</term>
<term>Proto-Oncogene Proteins c-bcr (genetics)</term>
<term>Reference Standards</term>
<term>World Health Organization</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Calibrage</term>
<term>Gènes abl</term>
<term>Humains</term>
<term>Normes de référence</term>
<term>Organisation mondiale de la santé</term>
<term>Protéines de fusion bcr-abl (analyse)</term>
<term>Protéines de fusion bcr-abl (normes)</term>
<term>Protéines proto-oncogènes c-bcr (génétique)</term>
<term>Réaction de polymérisation en chaîne</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en">
<term>Fusion Proteins, bcr-abl</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en">
<term>Proto-Oncogene Proteins c-bcr</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en">
<term>Fusion Proteins, bcr-abl</term>
</keywords>
<keywords scheme="MESH" qualifier="analyse" xml:lang="fr">
<term>Protéines de fusion bcr-abl</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Protéines proto-oncogènes c-bcr</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr">
<term>Protéines de fusion bcr-abl</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Calibration</term>
<term>Genes, abl</term>
<term>Humans</term>
<term>Polymerase Chain Reaction</term>
<term>Reference Standards</term>
<term>World Health Organization</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Calibrage</term>
<term>Gènes abl</term>
<term>Humains</term>
<term>Normes de référence</term>
<term>Organisation mondiale de la santé</term>
<term>Réaction de polymérisation en chaîne</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>Molecular monitoring of chronic myeloid leukemia patients using robust
<italic>BCR-ABL1</italic>
tests standardized to the International Scale (IS) is key to proper disease management, especially when treatment cessation is considered. Most laboratories currently use a time-consuming sample exchange process with reference laboratories for IS calibration. A World Health Organization (WHO)
<italic>BCR-ABL1</italic>
reference panel was developed (MR
<sup>1</sup>
–MR
<sup>4</sup>
), but access to the material is limited. In this study, we describe the development of the first cell-based secondary reference panel that is traceable to and faithfully replicates the WHO panel, with an additional MR
<sup>4.5</sup>
level. The secondary panel was calibrated to IS using digital PCR with
<italic>ABL1</italic>
,
<italic>BCR</italic>
and
<italic>GUSB</italic>
as reference genes and evaluated by 44 laboratories worldwide. Interestingly, we found that >40% of
<italic>BCR-ABL1</italic>
assays showed signs of inadequate optimization such as poor linearity and suboptimal PCR efficiency. Nonetheless, when optimized sample inputs were used, >60% demonstrated satisfactory IS accuracy, precision and/or MR
<sup>4.5</sup>
sensitivity, and 58% obtained IS conversion factors from the secondary reference concordant with their current values. Correlation analysis indicated no significant alterations in %BCR-ABL1 results caused by different assay configurations. More assays achieved good precision and/or sensitivity than IS accuracy, indicating the need for better IS calibration mechanisms.</p>
</div>
</front>
<back>
<div1 type="bibliography">
<listBibl>
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</listBibl>
</div1>
</back>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Bosnie-Herzégovine</li>
<li>Brésil</li>
<li>Bulgarie</li>
<li>Corée du Sud</li>
<li>Croatie</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Hongrie</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Portugal</li>
<li>Royaume-Uni</li>
<li>République populaire de Chine</li>
<li>République tchèque</li>
<li>Slovénie</li>
<li>États-Unis</li>
</country>
</list>
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<name sortKey="Cross, N C P" sort="Cross, N C P" uniqKey="Cross N" first="N C P" last="Cross">N C P. Cross</name>
</noRegion>
<name sortKey="Akiki, S" sort="Akiki, S" uniqKey="Akiki S" first="S" last="Akiki">S. Akiki</name>
<name sortKey="Anwar, J" sort="Anwar, J" uniqKey="Anwar J" first="J" last="Anwar">J. Anwar</name>
<name sortKey="Cross, N C P" sort="Cross, N C P" uniqKey="Cross N" first="N C P" last="Cross">N C P. Cross</name>
<name sortKey="Gerrard, G" sort="Gerrard, G" uniqKey="Gerrard G" first="G" last="Gerrard">G. Gerrard</name>
<name sortKey="Waits, P" sort="Waits, P" uniqKey="Waits P" first="P" last="Waits">P. Waits</name>
<name sortKey="White, H E" sort="White, H E" uniqKey="White H" first="H E" last="White">H E White</name>
<name sortKey="White, H E" sort="White, H E" uniqKey="White H" first="H E" last="White">H E White</name>
<name sortKey="Wilkinson, E" sort="Wilkinson, E" uniqKey="Wilkinson E" first="E" last="Wilkinson">E. Wilkinson</name>
</country>
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<name sortKey="Ernst, T" sort="Ernst, T" uniqKey="Ernst T" first="T" last="Ernst">T. Ernst</name>
</noRegion>
<name sortKey="Dietz, C" sort="Dietz, C" uniqKey="Dietz C" first="C" last="Dietz">C. Dietz</name>
<name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name>
<name sortKey="Jeromin, S" sort="Jeromin, S" uniqKey="Jeromin S" first="S" last="Jeromin">S. Jeromin</name>
<name sortKey="Muller, M C" sort="Muller, M C" uniqKey="Muller M" first="M C" last="Müller">M C Müller</name>
</country>
<country name="Australie">
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<name sortKey="Welden, L" sort="Welden, L" uniqKey="Welden L" first="L" last="Welden">L. Welden</name>
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<name sortKey="Radich, J" sort="Radich, J" uniqKey="Radich J" first="J" last="Radich">J. Radich</name>
<name sortKey="Wang, S S" sort="Wang, S S" uniqKey="Wang S" first="S-S" last="Wang">S-S Wang</name>
<name sortKey="Wong, S" sort="Wong, S" uniqKey="Wong S" first="S" last="Wong">S. Wong</name>
<name sortKey="Zheng, D" sort="Zheng, D" uniqKey="Zheng D" first="D" last="Zheng">D. Zheng</name>
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<name sortKey="Machova Polakova, K" sort="Machova Polakova, K" uniqKey="Machova Polakova K" first="K" last="Machova-Polakova">K. Machova-Polakova</name>
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<name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name>
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<noRegion>
<name sortKey="Mesanovic, S" sort="Mesanovic, S" uniqKey="Mesanovic S" first="S" last="Mesanovic">S. Mesanovic</name>
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