Standardization of Flow Cytometric Immunophenotyping for Hematological Malignancies: The FranceFlow Group Experience.
FranceFlow
flow cytometry
hematology
immunophenotyping
instrument settings
quality controls
standardization
Journal
Cytometry. Part A : the journal of the International Society for Analytical Cytology
ISSN: 1552-4930
Titre abrégé: Cytometry A
Pays: United States
ID NLM: 101235694
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
received:
27
12
2018
revised:
04
06
2019
accepted:
05
06
2019
pubmed:
1
8
2019
medline:
2
10
2020
entrez:
1
8
2019
Statut:
ppublish
Résumé
Flow cytometry is broadly used for the identification, characterization, and monitoring of hematological malignancies. However, the use of clinical flow cytometry is restricted by its lack of reproducibility across multiple centers. Since 2006, the EuroFlow consortium has been developing a standardized procedure detailing the whole process from instrument settings to data analysis. The FranceFlow group was created in 2010 with the intention to educate participating centers in France about the standardized instrument setting protocol (SOP) developed by the EuroFlow consortium and to organise several rounds of quality controls (QCs) in order to evaluate the feasibility of its application and its results. Here, we report the 5 year experience of the FranceFlow group and the results of the seven QCs of 23 instruments, involving up to 19 centers, in France and in Belgium. The FranceFlow group demonstrates that both the distribution and applicability of the SOP have been successful. Intercenter reproducibility was evaluated using both normal and pathological blood samples. Coefficients of variation (CVs) across the centers were <7% for the percentages of cell subsets and <30% for the median fluorescence intensities (MFIs) of the markers tested. Intracenter reproducibility provided similar results with CVs of <3% for the percentages of the majority of cell subsets, and CVs of <20% for the MFI values for the majority of markers. Altogether, the FranceFlow group show that the 19 participating labs might be considered as one unique laboratory with 23 identical flow cytometers able to reproduce identical results. Therefore, SOP significantly improves reproducibility of clinical flow in hematology and opens new avenues by providing a robust companion diagnostic tool for clinical trials in hematology. © 2019 International Society for Advancement of Cytometry.
Identifiants
pubmed: 31364809
doi: 10.1002/cyto.a.23844
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1008-1018Informations de copyright
© 2019 International Society for Advancement of Cytometry.
Références
Craig FE, Foon KA. Flow cytometric immunophenotyping for hematologic neoplasms. Blood 2008;111(8):3941-3967.
Preijers FW, Huys E, Favre C, Moshaver B. Establishment of harmonization in immunophenotyping: A comparative study of a standardized one-tube lymphocyte-screening panel. Cytometry B Clin Cytom 2014;86(6):418-425.
Fuertes I. Towards harmonization or standardization in governmental accounting? The international public sector accounting standards board experience. J Comp Policy Anal 2008;10(4):327-345.
Bene MC, Nebe T, Bettelheim P, Buldini B, Bumbea H, Kern W, Lacombe F, Lemez P, Marinov I, Matutes E, et al. Immunophenotyping of acute leukemia and lymphoproliferative disorders: aconsensus proposal of the European Leukemia Net Work Package 10. Leukemia 2011;25(4):567-574.
Costa ES, Pedreira CE, Barrena S, Lecrevisse Q, Flores J, Quijano S, Almeida J, del Carmen Garcia-Macias M, Bottcher S, Van Dongen JJ, et al. Automated pattern-guided principal component analysis vsexpert-based immunophenotypic classification of B-cell chronic lymphoproliferative disorders: a step forward in the standardization of clinical immunophenotyping. Leukemia 2010;24(11):1927-1933.
Feller N, van der Velden VH, Brooimans RA, Boeckx N, Preijers F, Kelder A, de Greef I, Westra G, Te Marvelde JG, Aerts P, et al. Defining consensus leukemia-associated immunophenotypes for detection of minimal residual disease in acute myeloid leukemia in a multicenter setting. Blood Cancer J 2013;3:e129.
Flores-Montero J, Sanoja-Flores L, Paiva B, Puig N, García-Sánchez O, Böttcher S, van der Velden VHJ, Pérez-Morán JJ, Vidriales MB, García-Sanz R, et al. Next generation flow for highly sensitive and standardized detection of minimal residual disease in multiple myeloma. Leukemia 2017;31(10):2094-2103.
Johansson U, Bloxham D, Couzens S, Jesson J, Morilla R, Erber W, Macey M, British Committee for Standards in Haematology. Guidelines on the use of multicolour flow cytometry in the diagnosis of haematological neoplasms. British Committee for Standards in haematology. Br J Haematol 2014;165(4):455-488.
Novakova M, Glier H, Brdickova N, Vlkova M, Santos AH, Lima M, Roussel M, Flores-Montero J, Szczepanski T, Bottcher S, et al. How to make usage of the standardized EuroFlow 8-color protocols possible for instruments of different manufacturers. J Immunol Methods 2017; pii: S0022-1759(17)30139-4.
Preijers FW, van der Velden VH, Preijers T, Brooimans RA, Marijt E, Homburg C, van Montfort K, Gratama JW. Fifteen years of external quality assessment in leukemia/lymphoma immunophenotyping in The Netherlands and Belgium: A way forward. Cytometry B Clin Cytom 2016;90(3):267-278.
Solly F, Rigollet L, Baseggio L, Guy J, Borgeot J, Guérin E, Debliquis A, Drenou B, Campos L, Lacombe F, et al. Comparable flow cytometry data can be obtained with two types of instruments, Canto II, and Navios. A GEIL study. Cytometry A 2013;83(12):1066-1072.
Theunissen P, Mejstrikova E, Sedek L, van der Sluijs-Gelling A, Gaipa G, Bartels M, Sobral da Costa E, Kotrová M, Novakova M, Sonneveld E, et al. Standardized flow cytometry for highly sensitive MRD measurements in B-cell acute lymphoblastic leukemia. Blood 2017;129(3):347-357.
Westers TM, Ireland R, Kern W, Alhan C, Balleisen JS, Bettelheim P, Burbury K, Cullen M, Cutler JA, Della Porta MG, et al. Standardization of flow cytometry in myelodysplastic syndromes: A report from an international consortium and the European LeukemiaNet working group. Leukemia 2012;26(7):1730-1741.
Wood BL, Arroz M, Barnett D, DiGiuseppe J, Greig B, Kussick SJ, Oldaker T, Shenkin M, Stone E, Wallace P. 2006 Bethesda International Consensus recommendations on the immunophenotypic analysis of hematolymphoid neoplasia by flow cytometry: optimal reagents and reporting for the flow cytometric diagnosis of hematopoietic neoplasia. Cytometry B ClinCytom 2007;72(Suppl 1):S14-S22.
Kalina T, Flores-Montero J, van der Velden VH, Martin-Ayuso M, Bottcher S, Ritgen M, Almeida J, Lhermitte L, Asnafi V, Mendonca A, et al. EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols. Leukemia 2012;26(9):1986-2010.
van Dongen JJ, Lhermitte L, Bottcher S, Almeida J, van der Velden VH, Flores-Montero J, Rawstron A, Asnafi V, Lecrevisse Q, Lucio P, et al. EuroFlow antibody panels for standardized n-dimensionalflow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia 2012;26(9):1908-1975.
Kalina T, Flores-Montero J, Lecrevisse Q, Pedreira CE, van der Velden VHJ, Novakova M, Mejstrikova E, Hrusak O, Böttcher S, Karsch D, et al. Quality assessment program for EuroFlow protocols: Summary results of four-year (2010-2013) quality assurance rounds. Cytometry A 2015;87(2):145-156.
Glier H, Heijnen I, Hauwel M, Dirks J, Quarroz S, Lehmann T, Rovo A, Arn K, Matthes T, Hogan C, et al. Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland. J Immunol Methods 2017; pii:S0022-1759(17)30205-3.
Moreau EJ, Matutes E, A'Hern RP, Morilla AM, Morilla RM, Owusu-Ankomah KA, Seon BK, Catovsky D. Improvement of the chronic lymphocytic leukemia scoring system with the monoclonal antibody SN8 (CD79b). Am J Clin Pathol 1997;108(4):378-382.