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

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

References:

URL

Impact factor

Impact factor: 2.996

RIV identification code

RIV/00216224:14110/21:00120995

Organization unit

Faculty of Medicine

DOI

https://doi.org/10.1080/10428194.2020.1861274

UT WoS

000603914300001

EID Scopus

2-s2.0-85098516810

Keywords in English

CE-IVD tests; BCR-ABL1 transcript monitoring; chronic myeloid leukemia

Abstract

In the original language

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

Cite

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://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 = {https://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://doi.org/10.1080/10428194.2020.1861274.

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