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Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium

Minimal residual disease (MRD) status is now considered as one of the most relevant prognostic factors in multiple myeloma (MM) while MRD negativity became an important endpoint in clinical trials. Here, we report the results of the first study evaluating the reproducibility of high-sensitivity flow...

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Autores principales: Krzywdzińska, Agnieszka, Puła, Bartosz, Czyż, Anna, Krzymieniewska, Beata, Kiernicka-Parulska, Jolanta, Mierzwa, Anna, Szymczak, Donata, Milanowska, Aneta, Kiraga, Aleksandra, Kwiecień, Iwona, Zaleska, Joanna, Jamroziak, Krzysztof
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534749/
https://www.ncbi.nlm.nih.gov/pubmed/34679569
http://dx.doi.org/10.3390/diagnostics11101872
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author Krzywdzińska, Agnieszka
Puła, Bartosz
Czyż, Anna
Krzymieniewska, Beata
Kiernicka-Parulska, Jolanta
Mierzwa, Anna
Szymczak, Donata
Milanowska, Aneta
Kiraga, Aleksandra
Kwiecień, Iwona
Zaleska, Joanna
Jamroziak, Krzysztof
author_facet Krzywdzińska, Agnieszka
Puła, Bartosz
Czyż, Anna
Krzymieniewska, Beata
Kiernicka-Parulska, Jolanta
Mierzwa, Anna
Szymczak, Donata
Milanowska, Aneta
Kiraga, Aleksandra
Kwiecień, Iwona
Zaleska, Joanna
Jamroziak, Krzysztof
author_sort Krzywdzińska, Agnieszka
collection PubMed
description Minimal residual disease (MRD) status is now considered as one of the most relevant prognostic factors in multiple myeloma (MM) while MRD negativity became an important endpoint in clinical trials. Here, we report the results of the first study evaluating the reproducibility of high-sensitivity flow cytometry MM MRD assessment in four laboratories in Poland. EuroFlow protocols for instrument setting standardization and sample preparation in MM MRD assessment were implemented in each laboratory. In the inter-laboratory reproducibility study, 12 bone marrow samples from MM patients were distributed and processed in participant laboratories. In the inter-operator concordance study, 13 raw data files from MM MRD measurements were analyzed by five independent operators. The inter-laboratory study showed high 95% overall concordance of results among laboratories. In the inter-operator study, 89% of MRD results reported were concordant, and the highest immunophenotype interpretation differences with regard to expression of CD27, CD45, CD81 were noticed. We confirmed the applicability and feasibility of the EuroFlow protocol as a highly sensitive method of MRD evaluation in MM. Results of our inter-center comparison study demonstrate that the standardization of MM MRD assessment protocols is highly desirable to improve quality and comparability of results within and between different clinical trials.
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spelling pubmed-85347492021-10-23 Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium Krzywdzińska, Agnieszka Puła, Bartosz Czyż, Anna Krzymieniewska, Beata Kiernicka-Parulska, Jolanta Mierzwa, Anna Szymczak, Donata Milanowska, Aneta Kiraga, Aleksandra Kwiecień, Iwona Zaleska, Joanna Jamroziak, Krzysztof Diagnostics (Basel) Article Minimal residual disease (MRD) status is now considered as one of the most relevant prognostic factors in multiple myeloma (MM) while MRD negativity became an important endpoint in clinical trials. Here, we report the results of the first study evaluating the reproducibility of high-sensitivity flow cytometry MM MRD assessment in four laboratories in Poland. EuroFlow protocols for instrument setting standardization and sample preparation in MM MRD assessment were implemented in each laboratory. In the inter-laboratory reproducibility study, 12 bone marrow samples from MM patients were distributed and processed in participant laboratories. In the inter-operator concordance study, 13 raw data files from MM MRD measurements were analyzed by five independent operators. The inter-laboratory study showed high 95% overall concordance of results among laboratories. In the inter-operator study, 89% of MRD results reported were concordant, and the highest immunophenotype interpretation differences with regard to expression of CD27, CD45, CD81 were noticed. We confirmed the applicability and feasibility of the EuroFlow protocol as a highly sensitive method of MRD evaluation in MM. Results of our inter-center comparison study demonstrate that the standardization of MM MRD assessment protocols is highly desirable to improve quality and comparability of results within and between different clinical trials. MDPI 2021-10-11 /pmc/articles/PMC8534749/ /pubmed/34679569 http://dx.doi.org/10.3390/diagnostics11101872 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Krzywdzińska, Agnieszka
Puła, Bartosz
Czyż, Anna
Krzymieniewska, Beata
Kiernicka-Parulska, Jolanta
Mierzwa, Anna
Szymczak, Donata
Milanowska, Aneta
Kiraga, Aleksandra
Kwiecień, Iwona
Zaleska, Joanna
Jamroziak, Krzysztof
Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title_full Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title_fullStr Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title_full_unstemmed Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title_short Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
title_sort harmonization of flow cytometric minimal residual disease assessment in multiple myeloma in centers of polish myeloma consortium
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534749/
https://www.ncbi.nlm.nih.gov/pubmed/34679569
http://dx.doi.org/10.3390/diagnostics11101872
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