Interlaboratory consensus on the immunophenotypic diagnosis of chronic lymphocytic leukemia: Recommendations for the preparation of cytometric study reports and the selection of panels of monoclonal antibodies
E. N. Parovichnikova,
E. V. Naumova,
V. N. Dvirnyk,
E. I. Zakharko,
D. G. Drokova,
К. A. Nikiforova,
E. V. Babenko,
Е. А. Belyakova,
Yu. V. Mirolyubova,
N. V. Pronkina,
Z. V. Chubukina,
Е. A. Lubyako,
Е. A. Partylyova,
T. Yu. Verzbitskaya,
O. N. Selyutina,
E. V. Boyakova,
S. A. Lugovskaya,
L. Yu. Gryvtsova,
I. V. Galtseva https://doi.org/10.35754/0234-5730-2025-70-1-114-127
Abstract
Introduction. Immunophenotyping is a key diagnostic method for chronic lymphocytic leukemia (CLL), the most common lymphoproliferative disorder (LPD) in middle-aged and elderly individuals. Given the high prevalence of CLL, there is a need to standardize approaches to its immunophenotypic diagnosis, including the development of standardized panels of monoclonal antibodies, recommendations for sample preparation, and the formulation of reports to improve diagnostic accuracy.
Aim: to develop a unified laboratory report form and a standardized approach to using the necessary and sufficient combination of labeled monoclonal antibodies for the diagnosis of CLL.
Main findings. An All-Russian working group was formed under the National Hematological Society (NHS) to discuss key issues in the laboratory diagnosis of CLL. The primary focus was on problems related to immunophenotyping. Consensus decisions were made regarding the creation of a unified laboratory report form and a standardized approach to using the necessary and sufficient combination of labeled monoclonal antibodies for the diagnosis of CLL. The monoclonal antibody panel should include antibodies detecting CD19, CD20, CD5, CD23, and surface immunoglobulin light chains (k and λ). To differentiate CLL from other B-LPDs, additional markers such as CD43, CD200, CD10, CD22, and CD38 are recommended. The report form should include, along with patient information and sample type, the following: a list of used monoclonal antibodies, the flow cytometer model, the count of leukocytes and lymphocytes, the immunophenotype of the identified tumor population with emphasis on aberrant markers, the absolute count of pathological clone cells, and the final immunophenotypic variant of CLL or B-LPD.
Keywords
chronic lymphocytic leukemia,
B-cell lymphoproliferative neoplasms,
multicolor flow cytometry,
immunophenotyping
Supporting agencies: the study had no financial support.
About the Authors
E. N. Parovichnikova
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Elena N. Parovichnikova, Dr. Sci. (Med.), CEO
125167, Moscow
E. V. Naumova
Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Professional Education; Moscow Multidisciplinary Scientific and Clinical Center named after S.P. Botkin
Russian Federation
Russian Federation
Elena V. Naumova, Cand. Sci. (Med.), Associate Professor of the Department of Clinical Laboratory Diagnostics with a Course in Laboratory Immunology at the Federal State Budgetary Educational Institution of Additional Professional
125993, Moscow; 125284, Moscow
V. N. Dvirnyk
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Valentina N. Dvirnyk, Cand. Sci. (Med.), Head of the Laboratory, Clinical Laboratory Diagnostics Physician at the Centralized Clinical and Diagnostic Laboratory
125167, Moscow
E. I. Zakharko
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Ekaterina I. Zakharko, Head of the Flow Cytometry Group of the Centralized Clinical and Diagnostic Laboratory
125167, Moscow
D. G. Drokova
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Darya G. Drokova, Clinical Laboratory Diagnostics Physician at the Centralized Clinical and Diagnostic Laboratory, Flow Cytometry Group
125167, Moscow
К. A. Nikiforova
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Kseniya A. Nikiforova, biologist in Scientific and Clinical Laboratory for Immunophenotyping of Blood and Bone Marrow Cells
125167, Moscow
E. V. Babenko
Research Institute of Pediatric Oncology, Hematology, and Transplantation named after R.M. Gorbacheva
Russian Federation
Russian Federation
Elena V. Babenko, Head of the Cryopreservation Department with the Laboratory of Quality Control of Hematopoietic Cells
197022, Saint-Petersburg
Е. А. Belyakova
North-Western State Medical University named after I.I. Mechnikov
Russian Federation
Russian Federation
Elena A. Belyakova, Clinical Laboratory Diagnostics Physician, Pathologist at the Pathological Anatomical Department of Clinical Molecular Morphology at the Federal State Budgetary Educational Institution of Higher Education
191015, Saint-Petersburg
Yu. V. Mirolyubova
National Medical Research Center named after V.A. Almazov
Russian Federation
Russian Federation
Yulia V. Mirolyubova, Cand. Sci. (Med.), Assistant at the Department of Laboratory Medicine with a Clinic
197341, Saint-Petersburg
N. V. Pronkina
Research Institute of Fundamental and Clinical Immunology
Russian Federation
Russian Federation
Natalia V. Pronkina, Cand. Sci. (Biol.), Head of the Laboratory, Biologist at the Clinical Immunology Laboratory
630099, Novosibirsk
Z. V. Chubukina
Russian Research Institute of Hematology and Transfusiology
Russian Federation
Russian Federation
Zhanna V. Chubukina, Cand. Sci. (Med.), Head of the Laboratory and Clinical Laboratory Diagnostics Physician at the Clinical Immunology Clinic of the Research Center for Cellular and Molecular Pathology
191024, Saint-Petersburg
Е. A. Lubyako
Regional Clinical Hospital
Russian Federation
Russian Federation
Elena A. Lubyako, Clinical Laboratory Diagnostics Physician at the Budgetary Institution of Khanty-Mansi Autonomous Okrug — Yugra
628012, Khanty-Mansiysk
Е. A. Partylyova
Sverdlovsk Regional Clinical Hospital No. 1
Russian Federation
Russian Federation
Elena A. Partylyova, Cand. Sci. (Med.), Clinical Laboratory Diagnostics Physician at the Immunology Department of the Laboratory Diagnostics Division of the State Autonomous Healthcare Institution
620102, Ekaterinburg
T. Yu. Verzbitskaya
Regional Children’s Clinical Hospital; Region Institute of Medical Cellular Technologies
Russian Federation
Russian Federation
Tatyana Yu. Verzhbitskaya, Cand. Sci. (Med.), Clinical Laboratory Diagnostics Physician at the State Autonomous Healthcare Institution of the Sverdlovsk
620149, Ekaterinburg; 620026, Ekaterinburg
O. N. Selyutina
National Medical Research Center of Oncology
Russian Federation
Russian Federation
Olesya N. Selyutina, Cand. Sci. (Biol.), Biologist at the Clinical and Diagnostic Laboratory
344037, Rostov-on-Don
E. V. Boyakova
O.K. Gavrilov Blood Center
Russian Federation
Russian Federation
Elena V. Boyakova, Cand. Sci. (Med.), Head of the Laboratory of Physiology and Pathology of Hematopoiesis with a Cryobank
125284, Moscow
S. A. Lugovskaya
Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Professional Education; Moscow Multidisciplinary Scientific and Clinical Center named after S.P. Botkin
Russian Federation
Russian Federation
Svetlana A. Lugovskaya, Dr. Sci.. (Med.), Professor at the Department of Clinical Laboratory Diagnostics
125993, Moscow; 125284, Moscow
L. Yu. Gryvtsova
Obninsk Institute of Nuclear Energy, a branch of the National Research Nuclear University “MEPhI”; A.F. Tsyb Medical Radiological Research Center, a branch of the National Medical Research Center of Radiology
Russian Federation
Russian Federation
Lyudmila Yu. Gryvtsova, Dr. Sci. (Biol.), Professor of the Department of Pathomorphology
249040, Obninsk; 249036, Obninsk
I. V. Galtseva
National Medical Research Center for Hematology
Russian Federation
Russian Federation
Irina V Galtseva, Dr. Sci. (Med.), Head of the Laboratory of Immunophenotyping of Blood and Bone Marrow Cells
125167, Moscow
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Review
For citations:
Parovichnikova E.N., Naumova E.V., Dvirnyk V.N., Zakharko E.I., Drokova D.G., Nikiforova К.A., Babenko E.V., Belyakova Е.А., Mirolyubova Yu.V., Pronkina N.V., Chubukina Z.V., Lubyako Е.A., Partylyova Е.A., Verzbitskaya T.Yu., Selyutina O.N., Boyakova E.V., Lugovskaya S.A., Gryvtsova L.Yu., Galtseva I.V. Interlaboratory consensus on the immunophenotypic diagnosis of chronic lymphocytic leukemia: Recommendations for the preparation of cytometric study reports and the selection of panels of monoclonal antibodies. Russian journal of hematology and transfusiology. 2025;70(1):114-127. (In Russ.) https://doi.org/10.35754/0234-5730-2025-70-1-114-127
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