Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA

Author:

White Helen E.1,Matejtschuk Paul2,Rigsby Peter2,Gabert Jean34,Lin Feng1,Lynn Wang Y.5,Branford Susan6,Müller Martin C.7,Beaufils Nathalie3,Beillard Emmanuel8,Colomer Dolors9,Dvorakova Dana10,Ehrencrona Hans11,Goh Hyun-Gyung12,El Housni Hakim13,Jones Dan14,Kairisto Veli15,Kamel-Reid Suzanne16,Kim Dong-Wook12,Langabeer Stephen17,Ma Edmond S. K.18,Press Richard D.19,Romeo Giuliana20,Wang Lihui21,Zoi Katerina22,Hughes Timothy23,Saglio Giuseppe24,Hochhaus Andreas25,Goldman John M.26,Metcalfe Paul2,Cross Nicholas C. P.127

Affiliation:

1. National Genetics Reference Laboratory Wessex, Salisbury District Hospital, Salisbury, United Kingdom;

2. National Institute for Biological Standards and Control, Health Protection Agency, South Mimms, United Kingdom;

3. Biochemistry and Molecular Laboratory, Hopital Nord–Assistance Publique–Hôpitaux de Marseille, Marseille, France;

4. Center for Research in Biological Oncology and Oncopharmacology, Inserm and Université de la Méditerranée, Marseille, France;

5. Molecular Hematopathology Laboratory, Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, NY;

6. Department of Molecular Pathology, SA Pathology and the University of Adelaide, Adelaide, Australia;

7. III Medizinische Klinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany;

8. MolecularMD, Portland, OR;

9. Unitat d'hematopatologia, Hospital Clinic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain;

10. University Hospital Brno and Masaryk University, Center of Molecular Biology and Gene Therapy, Brno, Czech Republic;

11. Department of Genetics and Pathology, Uppsala University, Uppsala, Sweden;

12. Molecular Genetics Research Institute, The Catholic University of Korea, Seoul, Republic of Korea;

13. Medical Genetics Department, Erasme Hospital, Brussels, Belgium;

14. Molecular Diagnostics Laboratory, The University of Texas M. D. Anderson Cancer Center, Houston, TX;

15. Turku University Hospital Laboratories, TYKSLAB, Turku, Finland;

16. Department of Pathology, The University Health Network, Toronto, ON;

17. Cancer Molecular Diagnostics, Central Pathology Laboratory, St James's Hospital, Dublin, Ireland;

18. Hong Kong Sanatorium and Hospital, Happy Valley, Hong Kong;

19. Department of Pathology, Oregon Health and Science University, Portland, OR;

20. Molecular Haematology Laboratory, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, Australia;

21. Department of Haematology, Royal Liverpool University Hospital, Liverpool, United Kingdom;

22. Haematology Research Laboratory, Biomedical Research Foundation, Academy of Athens, Athens, Greece;

23. Department of Haematology, SA Pathology and the University of Adelaide, Adelaide, Australia;

24. Department of Clinical and Biological Science, University of Turin, Turin, Italy;

25. Department Hematology/Oncology, Universitätsklinikum Jena, Jena, Germany;

26. Department of Haematology, Imperial College Academic Health Science Centre, Hammersmith Campus, London, United Kingdom; and

27. Human Genetics Division, University of Southampton School of Medicine, Southampton, United Kingdom

Abstract

Serial quantitation of BCR-ABL mRNA levels is an important indicator of therapeutic response for patients with chronic myelogenous leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia, but there is substantial variation in the real-time quantitative polymerase chain reaction methodologies used by different testing laboratories. To help improve the comparability of results between centers we sought to develop accredited reference reagents that are directly linked to the BCR-ABL international scale. After assessment of candidate cell lines, a reference material panel comprising 4 different dilution levels of freeze-dried preparations of K562 cells diluted in HL60 cells was prepared. After performance evaluation, the materials were assigned fixed percent BCR-ABL/control gene values according to the International Scale. A recommendation that the 4 materials be established as the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL translocation by real-time quantitative polymerase chain reaction was approved by the Expert Committee on Biological Standardization of the World Health Organization in November 2009. We consider that the development of these reagents is a significant milestone in the standardization of this clinically important test, but because they are a limited resource we suggest that their availability is restricted to manufacturers of secondary reference materials.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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