Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project

Andy C. Rawstron; Karl-anton Kreuzer; Asha Soosapilla; Martin Spacek; Olga Stehlikova; Peter Gambell; Neil Mciver-brown; Neus Villamor; Katherina Psarra; Maria Arroz; Raffaella Milani; Javier De La Serna; M. Teresa Cedena; Ozren Jaksic; Josep Nomdedeu; Carol Moreno; Gian Matteo Rigolin; Antonio Cuneo; Preben Johansen; Hans E. Johnsen; Richard Rosenquist; Carsten Utoft Niemann; Wolfgang Kern; David Westerman; Marek Trneny; Stephen Mulligan; Michael Doubek; Sarka Pospisilova; Peter Hillmen; David Oscier; Michael Hallek; Paolo Ghia; Emili Montserrat

doi:10.1002/cyto.b.21595

Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project

Andy C. Rawstron, Karl-anton Kreuzer, Asha Soosapilla, Martin Spacek, Olga Stehlikova, Peter Gambell, Neil Mciver-brown, Neus Villamor, Katherina Psarra, Maria Arroz, Raffaella Milani, Javier De La Serna, M. Teresa Cedena, Ozren Jaksic, Josep Nomdedeu, Carol Moreno, Gian Matteo Rigolin, Antonio Cuneo, Preben Johansen, Hans E. JohnsenRichard Rosenquist, Carsten Utoft Niemann, Wolfgang Kern, David Westerman, Marek Trneny, Stephen Mulligan, Michael Doubek, Sarka Pospisilova, Peter Hillmen, David Oscier, Michael Hallek, Paolo Ghia, Emili Montserrat

Department of Clinical Medicine

57 Citations (Scopus)

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Abstract

The diagnostic criteria for CLL rely on morphology and immunophenotype. Current approaches have limitations affecting reproducibility and there is no consensus on the role of new markers. The aim of this project was to identify reproducible criteria and consensus on markers recommended for the diagnosis of CLL. ERIC/ESCCA members classified 14 of 35 potential markers as “required” or “recommended” for CLL diagnosis, consensus being defined as >75% and >50% agreement, respectively. An approach to validate “required” markers using normal peripheral blood was developed. Responses were received from 150 participants with a diagnostic workload >20 CLL cases per week in 23/150 (15%), 5–20 in 82/150 (55%), and <5 cases per week in 45/150 (30%). The consensus for “required” diagnostic markers included: CD19, CD5, CD20, CD23, Kappa, and Lambda. “Recommended” markers potentially useful for differential diagnosis were: CD43, CD79b, CD81, CD200, CD10, and ROR1. Reproducible criteria for component reagents were assessed retrospectively in 14,643 cases from 13 different centers and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in 11 centers. Markers considered as “required” for the diagnosis of CLL by the participants in this study (CD19, CD5, CD20, CD23, Kappa, and Lambda) are consistent with current diagnostic criteria and practice. Importantly, a reproducible approach to validate and apply these markers in individual laboratories has been identified. Finally, a consensus “recommended” panel of markers to refine diagnosis in borderline cases (CD43, CD79b, CD81, CD200, CD10, and ROR1) has been defined and will be prospectively evaluated.

Original language	English
Journal	Cytometry. Part B: Clinical Cytometry
Volume	94
Issue number	1
Pages (from-to)	121-128
Number of pages	8
ISSN	1552-4949
DOIs	https://doi.org/10.1002/cyto.b.21595
Publication status	Published - Jan 2018

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Rawstron, A. C., Kreuzer, K., Soosapilla, A., Spacek, M., Stehlikova, O., Gambell, P., Mciver-brown, N., Villamor, N., Psarra, K., Arroz, M., Milani, R., De La Serna, J., Cedena, M. T., Jaksic, O., Nomdedeu, J., Moreno, C., Rigolin, G. M., Cuneo, A., Johansen, P., ... Montserrat, E. (2018). Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project. Cytometry. Part B: Clinical Cytometry, 94(1), 121-128. https://doi.org/10.1002/cyto.b.21595

Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project. / Rawstron, Andy C.; Kreuzer, Karl-anton; Soosapilla, Asha et al.
In: Cytometry. Part B: Clinical Cytometry, Vol. 94, No. 1, 01.2018, p. 121-128.

Research output: Contribution to journal › Journal article › Research › peer-review

Rawstron, AC, Kreuzer, K, Soosapilla, A, Spacek, M, Stehlikova, O, Gambell, P, Mciver-brown, N, Villamor, N, Psarra, K, Arroz, M, Milani, R, De La Serna, J, Cedena, MT, Jaksic, O, Nomdedeu, J, Moreno, C, Rigolin, GM, Cuneo, A, Johansen, P, Johnsen, HE, Rosenquist, R, Niemann, CU, Kern, W, Westerman, D, Trneny, M, Mulligan, S, Doubek, M, Pospisilova, S, Hillmen, P, Oscier, D, Hallek, M, Ghia, P & Montserrat, E 2018, 'Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project', Cytometry. Part B: Clinical Cytometry, vol. 94, no. 1, pp. 121-128. https://doi.org/10.1002/cyto.b.21595

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title = "Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project",

abstract = "The diagnostic criteria for CLL rely on morphology and immunophenotype. Current approaches have limitations affecting reproducibility and there is no consensus on the role of new markers. The aim of this project was to identify reproducible criteria and consensus on markers recommended for the diagnosis of CLL. ERIC/ESCCA members classified 14 of 35 potential markers as “required” or “recommended” for CLL diagnosis, consensus being defined as >75% and >50% agreement, respectively. An approach to validate “required” markers using normal peripheral blood was developed. Responses were received from 150 participants with a diagnostic workload >20 CLL cases per week in 23/150 (15%), 5–20 in 82/150 (55%), and <5 cases per week in 45/150 (30%). The consensus for “required” diagnostic markers included: CD19, CD5, CD20, CD23, Kappa, and Lambda. “Recommended” markers potentially useful for differential diagnosis were: CD43, CD79b, CD81, CD200, CD10, and ROR1. Reproducible criteria for component reagents were assessed retrospectively in 14,643 cases from 13 different centers and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in 11 centers. Markers considered as “required” for the diagnosis of CLL by the participants in this study (CD19, CD5, CD20, CD23, Kappa, and Lambda) are consistent with current diagnostic criteria and practice. Importantly, a reproducible approach to validate and apply these markers in individual laboratories has been identified. Finally, a consensus “recommended” panel of markers to refine diagnosis in borderline cases (CD43, CD79b, CD81, CD200, CD10, and ROR1) has been defined and will be prospectively evaluated.",

author = "Rawstron, {Andy C.} and Karl-anton Kreuzer and Asha Soosapilla and Martin Spacek and Olga Stehlikova and Peter Gambell and Neil Mciver-brown and Neus Villamor and Katherina Psarra and Maria Arroz and Raffaella Milani and {De La Serna}, Javier and Cedena, {M. Teresa} and Ozren Jaksic and Josep Nomdedeu and Carol Moreno and Rigolin, {Gian Matteo} and Antonio Cuneo and Preben Johansen and Johnsen, {Hans E.} and Richard Rosenquist and Niemann, {Carsten Utoft} and Wolfgang Kern and David Westerman and Marek Trneny and Stephen Mulligan and Michael Doubek and Sarka Pospisilova and Peter Hillmen and David Oscier and Michael Hallek and Paolo Ghia and Emili Montserrat",

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doi = "10.1002/cyto.b.21595",

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pages = "121--128",

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T1 - Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry

T2 - An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project

AU - Rawstron, Andy C.

AU - Kreuzer, Karl-anton

AU - Soosapilla, Asha

AU - Spacek, Martin

AU - Stehlikova, Olga

AU - Gambell, Peter

AU - Mciver-brown, Neil

AU - Villamor, Neus

AU - Psarra, Katherina

AU - Arroz, Maria

AU - Milani, Raffaella

AU - De La Serna, Javier

AU - Cedena, M. Teresa

AU - Jaksic, Ozren

AU - Nomdedeu, Josep

AU - Moreno, Carol

AU - Rigolin, Gian Matteo

AU - Cuneo, Antonio

AU - Johansen, Preben

AU - Johnsen, Hans E.

AU - Rosenquist, Richard

AU - Niemann, Carsten Utoft

AU - Kern, Wolfgang

AU - Westerman, David

AU - Trneny, Marek

AU - Mulligan, Stephen

AU - Doubek, Michael

AU - Pospisilova, Sarka

AU - Hillmen, Peter

AU - Oscier, David

AU - Hallek, Michael

AU - Ghia, Paolo

AU - Montserrat, Emili

PY - 2018/1

Y1 - 2018/1

N2 - The diagnostic criteria for CLL rely on morphology and immunophenotype. Current approaches have limitations affecting reproducibility and there is no consensus on the role of new markers. The aim of this project was to identify reproducible criteria and consensus on markers recommended for the diagnosis of CLL. ERIC/ESCCA members classified 14 of 35 potential markers as “required” or “recommended” for CLL diagnosis, consensus being defined as >75% and >50% agreement, respectively. An approach to validate “required” markers using normal peripheral blood was developed. Responses were received from 150 participants with a diagnostic workload >20 CLL cases per week in 23/150 (15%), 5–20 in 82/150 (55%), and <5 cases per week in 45/150 (30%). The consensus for “required” diagnostic markers included: CD19, CD5, CD20, CD23, Kappa, and Lambda. “Recommended” markers potentially useful for differential diagnosis were: CD43, CD79b, CD81, CD200, CD10, and ROR1. Reproducible criteria for component reagents were assessed retrospectively in 14,643 cases from 13 different centers and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in 11 centers. Markers considered as “required” for the diagnosis of CLL by the participants in this study (CD19, CD5, CD20, CD23, Kappa, and Lambda) are consistent with current diagnostic criteria and practice. Importantly, a reproducible approach to validate and apply these markers in individual laboratories has been identified. Finally, a consensus “recommended” panel of markers to refine diagnosis in borderline cases (CD43, CD79b, CD81, CD200, CD10, and ROR1) has been defined and will be prospectively evaluated.

AB - The diagnostic criteria for CLL rely on morphology and immunophenotype. Current approaches have limitations affecting reproducibility and there is no consensus on the role of new markers. The aim of this project was to identify reproducible criteria and consensus on markers recommended for the diagnosis of CLL. ERIC/ESCCA members classified 14 of 35 potential markers as “required” or “recommended” for CLL diagnosis, consensus being defined as >75% and >50% agreement, respectively. An approach to validate “required” markers using normal peripheral blood was developed. Responses were received from 150 participants with a diagnostic workload >20 CLL cases per week in 23/150 (15%), 5–20 in 82/150 (55%), and <5 cases per week in 45/150 (30%). The consensus for “required” diagnostic markers included: CD19, CD5, CD20, CD23, Kappa, and Lambda. “Recommended” markers potentially useful for differential diagnosis were: CD43, CD79b, CD81, CD200, CD10, and ROR1. Reproducible criteria for component reagents were assessed retrospectively in 14,643 cases from 13 different centers and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in 11 centers. Markers considered as “required” for the diagnosis of CLL by the participants in this study (CD19, CD5, CD20, CD23, Kappa, and Lambda) are consistent with current diagnostic criteria and practice. Importantly, a reproducible approach to validate and apply these markers in individual laboratories has been identified. Finally, a consensus “recommended” panel of markers to refine diagnosis in borderline cases (CD43, CD79b, CD81, CD200, CD10, and ROR1) has been defined and will be prospectively evaluated.

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DO - 10.1002/cyto.b.21595

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SN - 1552-4949

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JO - Cytometry. Part B: Clinical Cytometry

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IS - 1

ER -

Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project

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