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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 C1
  • Kreuzer, Karl-Anton2
  • Soosapilla, Asha3
  • Spacek, Martin4
  • Stehlikova, Olga5
  • Gambell, Peter6
  • McIver-Brown, Neil7
  • Villamor, Neus8
  • Psarra, Katherina9
  • Arroz, Maria10
  • Milani, Raffaella11
  • de la Serna, Javier12
  • Cedena, M Teresa12
  • Jaksic, Ozren13
  • Nomdedeu, Josep14
  • Moreno, Carol14
  • Rigolin, Gian Matteo15
  • Cuneo, Antonio15
  • Johansen, Preben16
  • Johnsen, Hans E16
  • And 13 more
  • 1 St. James's Institute of Oncology, Leeds, UK.
  • 2 Universitätsklinikum Köln, Deutschland.
  • 3 Laverty Pathology, Sydney, Australia. , (Australia)
  • 4 University Hospital, Prague, Czech Republic. , (Czechia)
  • 5 Masaryk University, CEITEC and Department of Internal Medicine - Hematology and Oncology, University Hospital Brno, Czech Republic. , (Czechia)
  • 6 Peter MacCallum Cancer Centre, Melbourne, Australia. , (Australia)
  • 7 Royal Bournemouth Hospital, Bournemouth, UK.
  • 8 Hematopathology Unit Hospital Clínic, Barcelona, Spain. , (Spain)
  • 9 Evangelismos Hospital, Athens, Greece. , (Greece)
  • 10 Hospital S. Francisco Xavier, Lisbon, Portugal. , (Portugal)
  • 11 Ospedale San Raffaele, Milano, Italia.
  • 12 Hospital Universitario 12 de Octubre, Madrid, Spain. , (Spain)
  • 13 Dubrava University Hospital, Zagreb, Croatia. , (Croatia)
  • 14 Hospital de Sant Pau, Barcelona, Spain. , (Spain)
  • 15 Unife University Hospital, Italy. , (Italy)
  • 16 Department of Haematology, Clinical Cancer Research Centre, Aalborg University Hospital and Department of Clinical Medicine, Aalborg University, Denmark. , (Denmark)
  • 17 Department of Immunology, Genetics and Pathology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden. , (Sweden)
  • 18 Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. , (Denmark)
  • 19 MLL Munich Leukemia Laboratory, Munich, Germany. , (Germany)
  • 20 Università Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milano, Italia.
  • 21 University Barcelona, Department of Hematology, Hospital Clinic, Spain. , (Spain)
Published Article
Cytometry. Part B, Clinical cytometry
Publication Date
Oct 10, 2017
DOI: 10.1002/cyto.b.21595
PMID: 29024461


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 centres and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in eleven centres. 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, ROR1) has been defined and will be prospectively evaluated. This article is protected by copyright. All rights reserved.

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