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

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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	http://dx.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