Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA.
@article{White2010EstablishmentOT,
title={Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA.},
author={Helen E. White and Paul Matejtschuk and Peter Rigsby and Jean Gabert and Feng Lin and Yue Lynn Wang and Susan Branford and Martin C. M{\"u}ller and Nathalie Beaufils and Emmanuel Beillard and Dolors Colomer and Dana Dvoř{\'a}kov{\'a} and Hans Ehrencrona and Hyun-gyung Goh and Hakim El Housni and Dan Jones and Veli Kairisto and Suzanne Kamel‐Reid and Dong-Wook Kim and Stephen Langabeer and Edmond S K Ma and Richard D. Press and Giuliana Romeo and Lihui Wang and Katerina Zoi and Timothy P. Hughes and Giuseppe Saglio and Andreas Hochhaus and John M. Goldman and Paul Metcalfe and Nicholas C. P. Cross},
journal={Blood},
year={2010},
volume={116 22},
pages={
e111-7
}
}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. [] Key Method After assessment of candidate cell lines, a reference material panel comprising 4 different dilution levels of freeze-dried preparations of K562…
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References
SHOWING 1-10 OF 34 REFERENCES
Characterization of a reference material for BCR-ABL (M-BCR) mRNA quantitation by real-time amplification assays: towards new standards for gene expression measurements
- BiologyLeukemia
- 2007
It is suggested that freeze-dried cells can be used as quality control reagents with a range of analytical instrumentations and could enable the development of urgently needed international standards simulating clinically relevant levels of MRD.
Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations.
- BiologyThe Journal of molecular diagnostics : JMD
- 2007
There can be considerable variability of results from laboratory to laboratory, with log reduction calculations varying from 1.6 to 3 log between laboratories at the same dilution, and the need for optimization of real-time qRT-PCR is emphasized.
An international study to standardize the detection and quantitation of BCR-ABL transcripts from stabilized peripheral blood preparations by quantitative RT-PCR.
- Biology, MedicineHaematologica
- 2007
The study showed the feasibility of RQ-PCR standardization independent of the PCR machine used and no significant difference in the results achieved using LC and TM technologies was achieved.
Monitoring chronic myeloid leukaemia therapy by real‐time quantitative PCR in blood is a reliable alternative to bone marrow cytogenetics
- Medicine, BiologyBritish journal of haematology
- 1999
It is concluded that real‐time quantitative PCR monitoring of peripheral blood can be used to reliably monitor disease response in CML and was sensitive, reproducible, and readily detected a change in BCR‐ABL transcript levels in serial blood samples.
Standardization and quality control studies of ‘real-time’ quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia – A Europe Against Cancer Program
- BiologyLeukemia
- 2003
The development of standardized protocols for RQ-PCR analysis of FG transcripts provides a milestone for molecular determination of MRD levels and is likely to prove invaluable to the management of patients entered into multicenter therapeutic trials.
Quantitative determination of the hybrid Bcr‐Abl RNA in patients with chronic myelogenous leukaemia under interferon therapy
- Biology, MedicineBritish journal of haematology
- 1992
A variable number of malignant cells are present in the majority of CML patients in cytogenetic remission following interferon therapy, according to a quantitative method devised by studying serial dilutions of K562 RNA into normal RNA.
Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia
- MedicineLeukemia
- 2006
International harmonization should establish RQ-PCR measurement of BCR-ABL as the best method for monitoring treatment response for patients with CML.
Early detection of BCR-ABL transcripts by quantitative reverse transcriptase-polymerase chain reaction predicts outcome after allogeneic stem cell transplantation for chronic myeloid leukemia.
- Medicine, BiologyBlood
- 2001
The results suggest that quantitative RT-PCR performed early after SCT is useful for predicting outcome and may help to define the need for further treatment.
Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials.
- MedicineBlood
- 2008
The IS can deliver accurate comparison of molecular response rates between clinical trials when measured by different laboratories, and performance characteristics (bias and precision) for consistent interpretation of MMR after IS conversion are determined.
Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results.
- BiologyBlood
- 2006
Suggestions are made for harmonizing the differing methodologies for measuring BCR-ABL transcripts in patients with CML undergoing treatment and using a conversion factor whereby individual laboratories can express BCR -ABL transcript levels on an internationally agreed scale.


