Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients

Warning

This publication doesn't include Institute of Computer Science. It includes Faculty of Medicine. Official publication website can be found on muni.cz.

Authors	FOLTA Adam JURCEK Tomas KUBESOVA Blanka ŽÁČKOVÁ Daniela SEMERÁD Lukáš MAYER Jiří JEŽÍŠKOVÁ Ivana
Year of publication	2021
Type	Article in Periodical
Magazine / Source	LEUKEMIA & LYMPHOMA
MU Faculty or unit	Faculty of Medicine
Citation
web	https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1861274
Doi	https://doi.org/10.1080/10428194.2020.1861274
Keywords	CE-IVD tests; BCR-ABL1 transcript monitoring; chronic myeloid leukemia
Description	According to European Leukemia Network (ELN) recommendations, real-time quantitative PCR (qRT-PCR) is a conventional strategy for long-term BCR-ABL1 transcript monitoring in patients with chronic myeloid leukemia (CML) both during tyrosine kinase inhibitor (TKI) therapy and its discontinuation [1–5]. However, with the new Regulation (EU) 2017/746 coming, health institutions will have to start using CE-marked IVD (CE-IVD) devices (including kits, reagents, calibrators, etc.) for analyses. Thus, commercial CE-IVD tests will also enter into routine CML diagnostics in the near future.
Related projects:	Nové přístupy ve výzkumu, diagnostice a terapii hematologických malignit VII