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

J 2021

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

FOLTA, Adam, Tomas JURCEK, Blanka KUBESOVA, Daniela ŽÁČKOVÁ, Lukáš SEMERÁD et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

V originále

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 MU

Name: Nové přístupy ve výzkumu, diagnostice a terapii hematologických malignit VII (Acronym: VýDiTeHeMa VII)

Investor: Masaryk University, Category A

Citovat

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.

@article{1730584,
   author = {Folta, Adam and Jurcek, Tomas and Kubesova, Blanka and Žáčková, Daniela and Semerád, Lukáš and Mayer, Jiří and Ježíšková, Ivana},
   article_location = {LONDON},
   article_number = {5},
   doi = {http://dx.doi.org/10.1080/10428194.2020.1861274},
   keywords = {CE-IVD tests; BCR-ABL1 transcript monitoring; chronic myeloid leukemia},
   language = {eng},
   issn = {1042-8194},
   journal = {LEUKEMIA & LYMPHOMA},
   title = {Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients},
   url = {https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1861274},
   volume = {62},
   year = {2021}
}

TY  - JOUR
ID  - 1730584
AU  - Folta, Adam - Jurcek, Tomas - Kubesova, Blanka - Žáčková, Daniela - Semerád, Lukáš - Mayer, Jiří - Ježíšková, Ivana
PY  - 2021
TI  - Evaluation of two CE-IVD tests for BCR-ABL1 transcript monitoring of chronic myeloid leukemia patients
JF  - LEUKEMIA & LYMPHOMA
VL  - 62
IS  - 5
SP  - 1239-1242
EP  - 1239-1242
PB  - INFORMA HEALTHCARE
SN  - 10428194
KW  - CE-IVD tests
KW  - BCR-ABL1 transcript monitoring
KW  - chronic myeloid leukemia
UR  - https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1861274
L2  - https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1861274
N2  - 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.
ER  -

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. \textit{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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