Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study
Cochaux Pascale; Venturi Claudia; Hedblom Andreas; Veigaard Christopher; Naumann Nicole; Gniot Michal; Hochhaus Andreas; Ernst Thomas; Rose Susan J.; Mihok Luboslav; Pott Christiane; Engvall Marie; Langabeer Stephen E.; Touloumenidou Tasoula; Franke Georg N.; Gómez-Casares María Teresa; Rapado Inmaculada; Mešanović Semir; Colomer Dolors; Saussele Susanne; Gineikiene-Valentine Egle; Andersen Christina Søs Auður; Cayuela Jean-Michel; Polakova Katerina Machova; Vorkinn Ingvild; Moeckel Sylvia; Hayden Chloe; Jiménez-Velasco Antonio; Venniker-Punt Bianca; Zizkova Hana; Lion Thomas; Jurcek Tomas; Schäfer Vivien; Diamond Joana; White Helen E.; Izzo Barbara; Kairisto Veli; Vigneri Paolo; Hayette Sandrine; Meggyesi Nora; Cerveira Nuno; Gottardi Enrico; Zawada Magdalena; Balatzenko Gueorgui; Cross Nicholas C. P.; Balabanov Stefan; Dietz Christian; Nibourel Olivier; Ilea Anca; Müller Martin C.; Leibundgut Elisabeth Oppliger; Albano Francesco; Coriu Daniel; Zadro Renata; Mitterbauer-Hohendanner Gerlinde; Wilkinson Elizabeth; Panayiotidis Panayiotis; Salmon Matthew; Podgornik Helena; Barbany Gisela; Dulucq Stéphanie
https://urn.fi/URN:NBN:fi-fe2022081154796
Tiivistelmä
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.
Kokoelmat
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