An Extensive Quality Control and Quality Assurance (QC/QA) Program Significantly Improves Inter-Laboratory Concordance Rates of Flow-Cytometric Minimal Residual Disease Assessment in Acute Lymphoblastic Leukemia: An I-BFM-FLOW-Network Report
Por:
Maurer-Granofszky M, Schumich A, Buldini B, Gaipa G, Kappelmayer J, Mejstrikova E, Karawajew L, Rossi J, Suzan AÇ, Agriello E, Anastasiou-Grenzelia T, Barcala V, Barna G, Batinic D, Bourquin JP, Brüggemann M, Bukowska-Strakova K, Burnusuzov H, Carelli D, Deniz G, Dubravcic K, Feuerstein T, Gaillard MI, Galeano A, Giordano H, Gonzalez A, Groeneveld-Krentz S, Hevessy Z, Hrusak O, Iarossi MB, Jáksó P, Kloboves Prevodnik V, Kohlscheen S, Kreminska E, Maglia O, Malusardi C, Marinov N, Martin BM, Möller C, Nikulshin S, Palazzi J, Paterakis G, Popov A, Ratei R, Rodríguez C, Sajaroff EO, Sala S, Samardzija G, Sartor M, Scarparo P, Sedek L, Slavkovic B, Solari L, Svec P, Szczepanski T, Taparkou A, Torrebadell-Burriel M, Tzanoudaki M, Varotto E, Vernitsky H, Attarbaschi A, Schrappe M, Conter V, Biondi A, Felice M, Campbell M, Kiss C, Basso G, Dworzak MN and On Behalf Of I-Bfm-Flow-Network
Publicada:
6 dic 2021
Ahead of Print:
6 dic 2021
Resumen:
Simple Summary Standardization of flow-cytometric assessment of minimal residual disease in acute lymphoid leukemia (ALL) is necessary to allow concordant multicentric application of the methodology. This is a prerequisite for internationally collaborative trials, such as the AIEOP-BFM-ALL and the ALL IC-BFM trial. We developed and applied a comprehensive training and quality control program involving a large number of international laboratories within the I-BFM consortium to complement standardization of the methodology with an educational component as well as with persistent quality control measures to allow large ALL treatment trials which use multi-laboratory FCM-MRD assessments for risk stratification of pediatric patients with ALL. Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Munster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts.
Filiaciones:
Maurer-Granofszky M:
Children's Cancer Research Institute, Medical University of Vienna, 1090 Vienna, Austria
Schumich A:
Children's Cancer Research Institute, Medical University of Vienna, 1090 Vienna, Austria
Buldini B:
Pediatric Hematology, Oncology and Stem Cell Transplant Division, Maternal and Child Health Department, University of Padova, 35122 Padova, Italy
Gaipa G:
M. Tettamanti Foundation Research Center, Department of Pediatrics, University of Milano-Bicocca, 20900 Monza, Italy
Kappelmayer J:
Department of Laboratory Medicine, University of Debrecen, 4032 Debrecen, Hungary
Mejstrikova E:
Department of Paediatric Haematology and Oncology, University Hospital Motol, 150 06 Prague, Czech Republic
Karawajew L:
Department of Pediatric Oncology and Hematology, Charité Berlin, 10117 Berlin, Germany
Rossi J:
Cellular Immunology Laboratory, Hospital de Pediatria "Dr. Juan P. Garrahan", Buenos Aires C1245, Argentina
Suzan AÇ:
Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, 34452 Istanbul, Turkey
Agriello E:
LEB Laboratorio, Servicio de Hematologia Hospital Penna, Bahia Blanca B8000, Argentina
Anastasiou-Grenzelia T:
P.&A. Kyriakou Children's Hospital of Athens, 115 27 Athens, Greece
Barcala V:
Laboratory-Flow Cytometry, Citomlab, Buenos Aires C1406AWK, Argentina
Barna G:
1st Department of Pathology and Experimental Cancer Research, Semmelweis University, 1085 Budapest, Hungary
Batinic D:
Division of Laboratory Immunology, Department of Laboratory Diagnostics, University Hospital Centre Zagreb & School of Medicine, 10000 Zagreb, Croatia
Bourquin JP:
Department of Oncology and Children's Cancer Research Center, University Children's Hospital, 8032 Zurich, Switzerland
Brüggemann M:
Department of Hematology, University Hospital Schleswig-Holstein, 24105 Kiel, Germany
Bukowska-Strakova K:
Department of Clinical Immunology, Institute of Pediatrics, Jagiellonian University Medical College, 31-008 Krakow, Poland
Burnusuzov H:
Center of Competence "PERIMED", Department of Pediatrics, Department of Microbiology and Clinical Immunology, Medical University Plovdiv, 4002 Plovdiv, Bulgaria
Carelli D:
Hospital Guillermo Rawson, San Juan J5400, Argentina
Deniz G:
Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, 34452 Istanbul, Turkey
Dubravcic K:
Division of Laboratory Immunology, Department of Laboratory Diagnostics, University Hospital Centre Zagreb & School of Medicine, 10000 Zagreb, Croatia
Feuerstein T:
The Rina Zaizov Division of Pediatric Hematology-Oncology, Schneider's Children's Medical Center, Petah Tikva 4920235, Israel
Gaillard MI:
Bioquimica, Inmunologia, Hospital de Ninos Rocardo Gutierrez, Buenos Aires C1425EFD, Argentina
Galeano A:
Flow Cytometry Laboratory, FUNDALEU, Buenos Aires C1114, Argentina
Giordano H:
Fundación Pérez Scremini, Pediatric Hematology-Oncology Service, Pereira Rossell Hospital, Montevideo 11600, Uruguay
Gonzalez A:
PAPSI Laboratorio Mendoza, Rosario S2000, Argentina
Groeneveld-Krentz S:
Department of Pediatric Oncology and Hematology, Charité Berlin, 10117 Berlin, Germany
Hevessy Z:
Department of Laboratory Medicine, University of Debrecen, 4032 Debrecen, Hungary
Hrusak O:
Department of Paediatric Haematology and Oncology, University Hospital Motol, 150 06 Prague, Czech Republic
Iarossi MB:
Flow Cytometry Laboratory, Provincial Histocompatibility Reference Centre, CUCAIBA, Buenos Aires C1114, Argentina
Jáksó P:
Flow Cytometry Laboratory, Department of Pathology, Clinical Centre, University of Pécs, 7622 Pécs, Hungary
Kloboves Prevodnik V:
Department of Cytopathology, Institute of Oncology, 1000 Ljubljana, Slovenia
Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia
Kohlscheen S:
Department of Hematology, University Hospital Schleswig-Holstein, 24105 Kiel, Germany
Kreminska E:
Clinical Laboratory Diagnostics and Metrology of NCSH "OHMATDYT", Ministry of Heath of Ukraine, 01601 Kiev, Ukraine
Maglia O:
M. Tettamanti Foundation Research Center, Department of Pediatrics, University of Milano-Bicocca, 20900 Monza, Italy
Malusardi C:
Hospital de Clinica Jose de San Martin, Buenos Aires C1120, Argentina
Marinov N:
PINDA, Chilean National Pediatric Oncology Group, Hospital Roberto del Rio, Universidad de Chile, Santiago 8380418, Chile
Martin BM:
Laboratorio CEBAC SRL, Posadas N3300, Argentina
Möller C:
Department of Oncology and Children's Cancer Research Center, University Children's Hospital, 8032 Zurich, Switzerland
Nikulshin S:
Hematopathology and Flow Cytometry Division, Children's Clinical University Hospital, LV-1004 Riga, Latvia
Palazzi J:
IICT Labs, Rosario S2000, Argentina
Paterakis G:
Georgios Gennimatas General Hospital of Athens, 115 27 Athens, Greece
Popov A:
Laboratory of Leukemia Immunophenotyping, Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, 117997 Moscow, Russia
Ratei R:
Clinic for Hematology and Tumor Immunology, HELIOS Klinikum Berlin-Buch, 13125 Berlin, Germany
Rodríguez C:
Hospital Nacional de Clínicas, Universidad Nacional de Córdoba, Cordoba X5000HUA, Argentina
Sajaroff EO:
Cellular Immunology Laboratory, Hospital de Pediatria "Dr. Juan P. Garrahan", Buenos Aires C1245, Argentina
Sala S:
M. Tettamanti Foundation Research Center, Department of Pediatrics, University of Milano-Bicocca, 20900 Monza, Italy
Samardzija G:
Laboratory for Flow Cytometry and Immunology, Institute for Health and Protection of Mother and Child of Serbia, 11070 Belgrade, Serbia
Sartor M:
The Children's Hospital at Westmead, Sydney, NSW 2145, Australia
Scarparo P:
Pediatric Hematology, Oncology and Stem Cell Transplant Division, Maternal and Child Health Department, University of Padova, 35122 Padova, Italy
Sedek L:
Department of Microbiology and Immunology, Medical University of Silesia, 40-055 Katowice, Poland
Slavkovic B:
Laboratory for Flow Cytometry and Immunology, Institute for Health and Protection of Mother and Child of Serbia, 11070 Belgrade, Serbia
Solari L:
Servicio de Bioquimica, Hospital Posadas, Buenos Aires B1684, Argentina
Svec P:
National Institute of Children's Diseases, 831 01 Bratislava, Slovakia
Szczepanski T:
Department of Pediatric Hematology and Oncology, Zabrze, Medical University of Silesia, 40-055 Katowice, Poland
Taparkou A:
Department of Pediatric Oncology Hippokration General Hospital, 546 42 Thessaloniki, Greece
Torrebadell-Burriel M:
Pediatric Hematology and Oncology, Hospital Sant Joan de Déu, 08950 Barcelona, Spain
Tzanoudaki M:
Department of Immunology & Histocompatibility, "Agia Sophia" Children's Hospital, 115 27 Athens, Greece
Varotto E:
Pediatric Hematology, Oncology and Stem Cell Transplant Division, Maternal and Child Health Department, University of Padova, 35122 Padova, Italy
Vernitsky H:
Hematology Lab, Sheba Medical Center, Ramat Gan 52621, Israel
Attarbaschi A:
St. Anna Children's Hospital, Department of Pediatrics, Medical University of Vienna, 1090 Vienna, Austria
Schrappe M:
Department of Pediatrics, University Medical Center SchleswigHolstein, Christian-Albrechts-University of Kiel, 24118 Kiel, Germany
Conter V:
Clinica Pediatrica University degli Studi di Milano Biococca, Fondazione MBBM, 20900 Monza, Italy
Biondi A:
Clinica Pediatrica University degli Studi di Milano Biococca, Fondazione MBBM, 20900 Monza, Italy
Felice M:
Department of Hematology and Oncology, Hospital de Pediatria "Dr. Juan P. Garrahan", Buenos Aires C1245, Argentina
Campbell M:
PINDA, Chilean National Pediatric Oncology Group, Hospital Roberto del Rio, Universidad de Chile, Santiago 8380418, Chile
Kiss C:
Division of Pediatric Hematology-Oncology, Department of Pediatrics, Faculty of Medicine, University of Debrecen, 4032 Debrecen, Hungary
Basso G:
Pediatric Hematology, Oncology and Stem Cell Transplant Division, Maternal and Child Health Department, University of Padova, 35122 Padova, Italy
Dworzak MN:
Children's Cancer Research Institute, Medical University of Vienna, 1090 Vienna, Austria
St. Anna Children's Hospital, Department of Pediatrics, Medical University of Vienna, 1090 Vienna, Austria
Green Published, Green Accepted, gold
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