TY - JOUR
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.
U2 - 10.1002/cyto.b.21595
DO - 10.1002/cyto.b.21595
M3 - Journal article
C2 - 29024461
SN - 1552-4949
VL - 94
SP - 121
EP - 128
JO - Cytometry Part B - Clinical Cytometry
JF - Cytometry Part B - Clinical Cytometry
IS - 1
ER -