A1 Refereed original research article in a scientific journal
Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study
Authors: White Helen E., Salmon Matthew, Albano Francesco, Andersen Christina Søs Auður, Balabanov Stefan, Balatzenko Gueorgui, Barbany Gisela, Cayuela Jean-Michel, Cerveira Nuno, Cochaux Pascale, Colomer Dolors, Coriu Daniel, Diamond Joana, Dietz Christian, Dulucq Stéphanie, Engvall Marie, Franke Georg N., Gineikiene-Valentine Egle, Gniot Michal, Gómez-Casares María Teresa, Gottardi Enrico, Hayden Chloe, Hayette Sandrine, Hedblom Andreas, Ilea Anca, Izzo Barbara, Jiménez-Velasco Antonio, Jurcek Tomas, Kairisto Veli, Langabeer Stephen E., Lion Thomas, Meggyesi Nora, Mešanović Semir, Mihok Luboslav, Mitterbauer-Hohendanner Gerlinde, Moeckel Sylvia, Naumann Nicole, Nibourel Olivier, Leibundgut Elisabeth Oppliger, Panayiotidis Panayiotis, Podgornik Helena, Pott Christiane, Rapado Inmaculada, Rose Susan J., Schäfer Vivien, Touloumenidou Tasoula, Veigaard Christopher, Venniker-Punt Bianca, Venturi Claudia, Vigneri Paolo, Vorkinn Ingvild, Wilkinson Elizabeth, Zadro Renata, Zawada Magdalena, Zizkova Hana, Müller Martin C., Saussele Susanne, Ernst Thomas, Polakova Katerina Machova, Hochhaus Andreas, Cross Nicholas C. P.
Publisher: SPRINGERNATURE
Publication year: 2022
Journal: Leukemia
Journal acronym: LEUKEMIA
Volume: 36
Issue: 7
First page : 1834
Last page: 1842
Number of pages: 9
ISSN: 0887-6924
eISSN: 1476-5551
DOI: https://doi.org/10.1038/s41375-022-01607-z
Web address : https://www.nature.com/articles/s41375-022-01607-z
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/175858767
Standardized monitoring of BCR::ABL1 mRNA levels is essential for the management of chronic myeloid leukemia (CML) patients. From 2016 to 2021 the European Treatment and Outcome Study for CML (EUTOS) explored the use of secondary, lyophilized cell-based BCR::ABL1 reference panels traceable to the World Health Organization primary reference material to standardize and validate local laboratory tests. Panels were used to assign and validate conversion factors (CFs) to the International Scale and assess the ability of laboratories to assess deep molecular response (DMR). The study also explored aspects of internal quality control. The percentage of EUTOS reference laboratories (n = 50) with CFs validated as optimal or satisfactory increased from 67.5% to 97.6% and 36.4% to 91.7% for ABL1 and GUSB, respectively, during the study period and 98% of laboratories were able to detect MR4.5 in most samples. Laboratories with unvalidated CFs had a higher coefficient of variation for BCR::ABL1(IS) and some laboratories had a limit of blank greater than zero which could affect the accurate reporting of DMR. Our study indicates that secondary reference panels can be used effectively to obtain and validate CFs in a manner equivalent to sample exchange and can also be used to monitor additional aspects of quality assurance.
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