FOLTA, Adam, Tomas JURCEK, Blanka KUBESOVA, Daniela ŽÁČKOVÁ, Lukáš SEMERÁD, Jiří MAYER and Ivana JEŽÍŠKOVÁ. Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients. LEUKEMIA & LYMPHOMA. LONDON: INFORMA HEALTHCARE, 2021, vol. 62, No 5, p. 1239-1242. ISSN 1042-8194. Available from: https://dx.doi.org/10.1080/10428194.2020.1861274.
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Basic information
Original name Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients
Authors FOLTA, Adam (203 Czech Republic), Tomas JURCEK (203 Czech Republic), Blanka KUBESOVA (203 Czech Republic), Daniela ŽÁČKOVÁ (203 Czech Republic, belonging to the institution), Lukáš SEMERÁD (203 Czech Republic, belonging to the institution), Jiří MAYER (203 Czech Republic, belonging to the institution) and Ivana JEŽÍŠKOVÁ (203 Czech Republic, guarantor, belonging to the institution).
Edition LEUKEMIA & LYMPHOMA, LONDON, INFORMA HEALTHCARE, 2021, 1042-8194.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30205 Hematology
Country of publisher United Kingdom of Great Britain and Northern Ireland
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 2.996
RIV identification code RIV/00216224:14110/21:00120995
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1080/10428194.2020.1861274
UT WoS 000603914300001
Keywords in English CE-IVD tests; BCR-ABL1 transcript monitoring; chronic myeloid leukemia
Tags 14110212, podil, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 14/7/2021 07:11.
Abstract
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.
Links
MUNI/A/1395/2019, interní kód MUName: Nové přístupy ve výzkumu, diagnostice a terapii hematologických malignit VII (Acronym: VýDiTeHeMa VII)
Investor: Masaryk University, Category A
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