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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3330-3338.
Prepublished online as a Blood First Edition Paper on August 6, 2008; DOI 10.1182/blood-2008-04-150680.
 Previous Article | Next Article 
Submitted April 10, 2008
Accepted July 21, 2008
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
Susan Branford*, Linda Fletcher, Nicholas CP Cross, Martin C Muller, Andreas Hochhaus, Dong-Wook Kim, Jerald P. Radich, Giuseppe Saglio, Fabrizio Pane, Suzanne Kamel-Reid, Y. Lynn Wang, Richard D Press, Kevin Lynch, Zbigniew Rudzki, John M Goldman, and Timothy Hughes
Institute of Medical and Veterinary Science, Adelaide, South Australia, Australia
National Genetics Reference Laboratory, University of Southampton, Salisbury, United Kingdom
Medizinische Fakultat Mannheim, University of Heidelberg, Mannheim, Germany
St Mary's Hospital, The Catholic University of Korea, Seoul, Korea, Republic of
Fred Hutchinson Cancer Research, Seattle, WA, United States
Ospedale Universita di Torino, Turin, Italy
Hematology Unit, Ceinge and Dipartimento di Biochimica e Biotecnologie Mediche, University of Naples Federico II, Naples, Italy
Princess Margaret Hospital, Toronto, Ontario, Canada
Weill Medical College of Cornell University, New York, NY, United States
Oregon Health & Science University, Portland, OR, United States
Novartis Pharmaceuticals Australia, Sydney, Australia
Imperial College at Hammersmith Hospital, London, United Kingdom
* Corresponding author; email: susan.branford{at}imvs.sa.gov.au.
An international basis for comparison of BCR-ABL mRNA levels is required for the common interpretation of data derived from individual laboratories. This will not only aid clinical decisions for individual patients with CML but also assist the interpretation of results from clinical studies. We aligned BCR-ABL values generated by 38 international laboratories to an international reporting scale (IS) where a major molecular response (MMR) is defined as  0.10%. Alignment was achieved by application of laboratory-specific conversion factors calculated by comparisons performed with patient samples against a reference method. A validation procedure was completed for 19 methods. We determined performance characteristics (bias and precision) for consistent interpretation of MMR after IS conversion. When methods achieved an average BCR-ABL difference of ±1.2-fold from the reference method and 95% limits of agreement within ±5-fold, the concordance of MMR was 91%. These criteria were met by 58% of methods. When not met, the MMR concordance was 74%. However, irrespective of the precision, when the bias was ±1.2-fold as achieved by 89% of methods, there was good agreement between the overall rates of MMR. This indicates that the IS can deliver accurate comparison of molecular response rates between clinical trials when measured by different laboratories.
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