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| Leukemia. 2022 May 25. doi: 10.1038/s41375-022-01607-z. pii: 10.1038/s41375-022-01607-z |
| Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study. |
| White HE1, Salmon M2, Albano F3, Andersen CSA4, Balabanov S5, Balatzenko G6, Barbany G7, Cayuela JM8, Cerveira N9, Cochaux P10, Colomer D11, Coriu D12, Diamond J13, Dietz C14, Dulucq S15, Engvall M16, Franke GN17, Gineikiene-Valentine E18, Gniot M19, Gómez-Casares MT20, Gottardi E21, Hayden C22, Hayette S23, Hedblom A24, Ilea A25, Izzo B26, Jiménez-Velasco A27, Jurcek T28, Kairisto V29, Langabeer SE30, Lion T31, Meggyesi N32, Mešanović S33, Mihok L34, Mitterbauer-Hohendanner G35, Moeckel S36, Naumann N37, Nibourel O38, Oppliger Leibundgut E39, Panayiotidis P40, Podgornik H41, Pott C42, Rapado I43, Rose SJ44, Schäfer V45, Touloumenidou T46, Veigaard C47, Venniker-Punt B48, Venturi C49, Vigneri P50, Vorkinn I51, Wilkinson E52, Zadro R53, Zawada M54, Zizkova H55, Müller MC56, Saussele S57, Ernst T58, Machova Polakova K59, Hochhaus A60, Cross NCP61 |
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Abstract 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 MR in most samples. Laboratories with unvalidated CFs had a higher coefficient of variation for BCR::ABL1 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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© 2022. The Author(s). |
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Publikations ID: 35614319 Quelle: öffnen |
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