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| Leukemia. 2016 Apr 25. pii: leu201690. doi: 10.1038/leu.2016.90 |
| Development and evaluation of a secondary reference panel for BCR-ABL1 quantitation on the International Scale. |
| Cross NC1, White HE2, Ernst T3, Welden L4, Dietz C5, Saglio G6, Mahon FX7, Wong CC8, Zheng D9, Wong S10, Wang SS11, Akiki S12, Albano F13, Andrikovics H14, Anwar J15, Balatzenko G16, Bendit I17, Beveridge J18, Boeckx N19, Cerveira N20, Cheng SM21, Colomer D22, Czurda S23, Daraio F24, Dulucq S25, Eggen L26, El Housni H27, Gerrard G28, Gniot M29, Izzo B30, Jacquin D31, Janssen JJ32, Jeromin S33, Jurcek T34, Kim DW35, Machova-Polakova K36, Martinez-Lopez J37, McBean M38, Mesanovic S39, Mitterbauer-Hohendanner G40, Mobtaker H41, Mozziconacci MJ42, Pajič T43, Pallisgaard N44, Panagiotidis P45, Press RD46, Qin YZ47, Radich J48, Sacha T49, Touloumenidou T50, Waits P51, Wilkinson E52, Zadro R53, Müller MC54, Hochhaus A55, Branford S56 |
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Abstract 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 utilize 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's 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 ones. 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.Leukemia accepted article preview online, 25 April 2016. doi:10.1038/leu.2016.90. |
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Publikations ID: 27109508 Quelle: öffnen |
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