Development and evaluation of a secondary reference panel for BCR-ABL1 quantification on the International Scale
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 ref...
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Published in | Leukemia Vol. 30; no. 9; pp. 1844 - 1852 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
London
Nature Publishing Group UK
01.09.2016
Nature Publishing Group |
Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 0887-6924 1476-5551 |
DOI: | 10.1038/leu.2016.90 |