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

• Autoři: FOLTA Adam; JURCEK Tomas; KUBESOVA Blanka; ŽÁČKOVÁ Daniela; SEMERÁD Lukáš; MAYER Jiří; JEŽÍŠKOVÁ Ivana
• Rok publikování: 2021
• Druh: Článek v odborném periodiku
• Časopis / Zdroj: LEUKEMIA & LYMPHOMA
• Fakulta / Pracoviště MU: Lékařská fakulta
• www: https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1861274
• Doi: http://dx.doi.org/10.1080/10428194.2020.1861274
• Klíčová slova: CE-IVD tests; BCR-ABL1 transcript monitoring; chronic myeloid leukemia
• Popis: 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.

Související projekty

• Nové přístupy ve výzkumu, diagnostice a terapii hematologických malignit VII