Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients
| Authors | |
|---|---|
| Year of publication | 2021 |
| Type | Article in Periodical |
| Magazine / Source | LEUKEMIA & LYMPHOMA |
| MU Faculty or unit | |
| 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. |
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