Development and evaluation of a secondary reference panel for BCR-ABL1 quantification on the International Scale
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články
PubMed
27109508
PubMed Central
PMC5240017
DOI
10.1038/leu.2016.90
PII: leu201690
Knihovny.cz E-zdroje
- MeSH
- bcr-abl fúzní proteiny analýza normy MeSH
- geny abl MeSH
- kalibrace MeSH
- lidé MeSH
- polymerázová řetězová reakce MeSH
- protoonkogenní proteiny c-bcr genetika MeSH
- referenční standardy MeSH
- Světová zdravotnická organizace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- BCR protein, human MeSH Prohlížeč
- bcr-abl fúzní proteiny MeSH
- protoonkogenní proteiny c-bcr MeSH
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 (MR(1)-MR(4)), 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(4.5) 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 MR(4.5) 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.
3 Medizinische Klinik Medizinische Fakultät Mannheim Universität Heidelberg Mannheim Germany
Bergonie Institute Cancer Center Bordeaux INSERM U1218 University of Bordeaux Bordeaux France
Bristol Genetics Laboratory Bristol UK
CEINGE Biotecnologie Avanzate Naples Italy
Chair and Department of Hematology Jagiellonian University Kraków Poland
Clinique de Genetique Oncologique Service de genetique Hopital Erasme Brussels Belgium
Departement de Biopathologie Institut Paoli Calmettes Marseille France
Department of Clinical Medicine and Surgery University 'Federico II' of Naples Naples Italy
Department of Genetics Portuguese Oncology Institute Porto Portugal
Department of Hematology and Oncology Quest Diagnostics Nichols Institute San Juan Capistrano CA USA
Department of Hematology Oncology Universitätsklinikum Jena Jena Germany
Department of Hematology University of Bari Bari Italy
Department of Laboratory Medicine University Hospitals Leuven Leuven Belgium
Department of Molecular Genetics Institute of Hematology and Blood Transfusion Prague Czech Republic
Department of Oncology KUL Leuven Belgium
Department of Pathophysiology Semmelweis University Budapest Hungary
Department of Surgical Pathology Zealand University Hospital Roskilde Denmark
Division of Molecular Microbiology Children's Cancer Research Institute Vienna Austria
Faculty of Medicine University of Southampton Southampton UK
Fred Hutchinson Cancer Research Center Seattle WA USA
Hematopathology Unit Hospital Clinic IDIBAPS Barcelona Spain
HMDS Leeds Teaching Hospitals Leeds UK
Imperial Molecular Pathology Hammersmith Hospital London UK
King's College Hospital London London UK
Laboratorio de Biologia Tumoral Disciplina de Hematologia do HC FMUSP São Paulo Brazil
Laboratory of Molecular Diagnostics Hungarian National Blood Transfusion Service Budapest Hungary
Laboratory of Molecular Pathology Oslo University Hospital Oslo Norway
MLL Munich Leukemia Laboratory Munich Germany
National Specialized Hospital for Active Treatment of Hematological Diseases Sofia Bulgaria
Novartis Pharmaceuticals Corporation East Hanover NJ USA
Pathology Department University Clinical Center Tuzla Tuzla Bosnia and Herzegovina
PathWest Laboratory Medicine WA Department of Haematology Fiona Stanley Hospital Perth WA Australia
Peking University People's Hospital Peking University Institute of Hematology Beijing China
School of Medicine University of Adelaide SA Adelaide Australia
School of Molecular and Biomedical Science University of Adelaide Adelaide SA Australia
School of Pharmacy and Medical Science University of South Australia Adelaide SA Australia
Seoul St Mary's Hospital Leukemia Research Institute The Catholic University of Korea Seoul Korea
Wessex Regional Genetics Laboratory Salisbury NHS Foundation Trust Salisbury UK
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