Establishment of the first World Health Organization international genetic reference panel for quantitation of BCR-ABL mRNA

White, Helen E., Matejtschuk, Paul, Rigsby, Peter, Gabert, Jean, Lin, Feng, Wang, Y. Lynn, Branford, Susan, Muller, Martin C., Beaufils, Nathalie, Beillard, Emmanuel, Colomer, Dolors, Dvorakova, Dana, Ehrencrona, Hans, Goh, Hyun-Gyung, El Housni, Hakim, Jones, Dan, Kairisto, Veli, Kamel-Reid, Suzanne, Kim, Dong-Wook, Langabeer, Stephen, Ma, Edmund S.K., Press, Richard D., Romeo, Giuliana, Wang, Lihui, Zoi, Katerina, Hughes, Timothy, Saglio, Giuseppe, Hochhaus, Andreas, Goldman, John M., Metcalfe, Paul and Cross, Nicholas C.P. (2010) Establishment of the first World Health Organization international genetic reference panel for quantitation of BCR-ABL mRNA. Blood, 116 (22), 111-117. (doi:10.1182/blood-2010-06-291641). (PMID:20720184)

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 PCR (RQ-PCR) methodologies that are employed 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. Following assessment of candidate cell lines, a reference material panel comprising four different dilution levels of freeze dried preparations of K562 cells diluted in HL60 cells was prepared. Following performance evaluation, the materials were assigned fixed % BCR-ABL/control gene values according to the International Scale. A recommendation that the four materials be established as the 1st World Health Organization (WHO) International Genetic Reference Panel for quantitation of BCR-ABL translocation by RQ-PCR was approved by the Expert Committee on Biological Standardization of the WHO in November 2009. We consider that the development of these reagents is a significant milestone in the standardization of this clinically important test, but since they are a limited resource we suggest that their availability is restricted to manufacturers of secondary reference materials.

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Contributors

Author: Nicholas C.P. Cross

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