Harmonization of Flow Cytometric Minimal Residual Disease Assessment in Multiple Myeloma in Centers of Polish Myeloma Consortium
Agnieszka Krzywdzińska,
Bartosz Puła,
Anna Czyż,
Beata Krzymieniewska,
Jolanta Kiernicka-Parulska,
Anna Mierzwa,
Donata Szymczak,
Aneta Milanowska,
Aleksandra Kiraga,
Iwona Kwiecień,
Joanna Zaleska,
Krzysztof Jamroziak
Affiliations
Agnieszka Krzywdzińska
Laboratory of Immunophenotyping, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland
Bartosz Puła
Department of Hematology, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland
Anna Czyż
Department of Hematology and Bone Marrow Transplantation, Wroclaw Medical University, 50-367 Wroclaw, Poland
Beata Krzymieniewska
Laboratory of Immunophenotyping, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland
Jolanta Kiernicka-Parulska
Flow Cytometry Laboratory, Haematology Clinical Laboratory, Department of Haematology and Bone Marrow Transplantation, University Hospital of Lord’s Transfiguration, 60-101 Poznan, Poland
Anna Mierzwa
Flow Cytometry Laboratory, Haematology Clinical Laboratory, Department of Haematology and Bone Marrow Transplantation, University Hospital of Lord’s Transfiguration, 60-101 Poznan, Poland
Donata Szymczak
Flow Cytometry and Cytomorphology Laboratory, Department and Clinic of Haematology, Blood Neoplasms and Bone Marrow Transplantation, University Hospital in Wroclaw, 50-367 Wroclaw, Poland
Aneta Milanowska
Flow Cytometry and Cytomorphology Laboratory, Department and Clinic of Haematology, Blood Neoplasms and Bone Marrow Transplantation, University Hospital in Wroclaw, 50-367 Wroclaw, Poland
Aleksandra Kiraga
Flow Cytometry and Cytomorphology Laboratory, Department and Clinic of Haematology, Blood Neoplasms and Bone Marrow Transplantation, University Hospital in Wroclaw, 50-367 Wroclaw, Poland
Iwona Kwiecień
Laboratory of Hematology and Flow Cytometry, Department of Internal Medicine and Hematology, Military Institute of Medicine, 04-141 Warsaw, Poland
Joanna Zaleska
Department of Experimental Hematooncology, Medical University of Lublin, 20-059 Lublin, Poland
Krzysztof Jamroziak
Department of Hematology, Transplantation and Internal Medicine, Medical University of Warsaw, 02-097 Warsaw, Poland
Minimal residual disease (MRD) status is now considered as one of the most relevant prognostic factors in multiple myeloma (MM) while MRD negativity became an important endpoint in clinical trials. Here, we report the results of the first study evaluating the reproducibility of high-sensitivity flow cytometry MM MRD assessment in four laboratories in Poland. EuroFlow protocols for instrument setting standardization and sample preparation in MM MRD assessment were implemented in each laboratory. In the inter-laboratory reproducibility study, 12 bone marrow samples from MM patients were distributed and processed in participant laboratories. In the inter-operator concordance study, 13 raw data files from MM MRD measurements were analyzed by five independent operators. The inter-laboratory study showed high 95% overall concordance of results among laboratories. In the inter-operator study, 89% of MRD results reported were concordant, and the highest immunophenotype interpretation differences with regard to expression of CD27, CD45, CD81 were noticed. We confirmed the applicability and feasibility of the EuroFlow protocol as a highly sensitive method of MRD evaluation in MM. Results of our inter-center comparison study demonstrate that the standardization of MM MRD assessment protocols is highly desirable to improve quality and comparability of results within and between different clinical trials.
