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    Cancers. 2021 Dec 6. pii: cancers13236148. doi: 10.3390/cancers13236148
    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.
    Maurer-Granofszky M1,  Schumich A2,  Buldini B3,  Gaipa G4,  Kappelmayer J5,  Mejstrikova E6,  Karawajew L7,  Rossi J8,  Suzan AÇ9,  Agriello E10,  Anastasiou-Grenzelia T11,  Barcala V12,  Barna G13,  Batinić D14,  Bourquin JP15,  Brüggemann M16,  Bukowska-Strakova K17,  Burnusuzov H18,  Carelli D19,  Deniz G20,  Dubravčić K21,  Feuerstein T22,  Gaillard MI23,  Galeano A24,  Giordano H25,  Gonzalez A26,  Groeneveld-Krentz S27,  Hevessy Z28,  Hrusak O29,  Iarossi MB30,  Jáksó P31,  Kloboves Prevodnik V32,  Kohlscheen S33,  Kreminska E34,  Maglia O35,  Malusardi C36,  Marinov N37,  Martin BM38,  Möller C39,  Nikulshin S40,  Palazzi J41,  Paterakis G42,  Popov A43,  Ratei R44,  Rodríguez C45,  Sajaroff EO46,  Sala S47,  Samardzija G48,  Sartor M49,  Scarparo P50,  Sędek Ł51,  Slavkovic B52,  Solari L53,  Svec P54,  Szczepanski T55,  Taparkou A56,  Torrebadell M57,  Tzanoudaki M58,  Varotto E59,  Vernitsky H60,  Attarbaschi A61,  Schrappe M62,  Conter V63,  Biondi A64,  Felice M65,  Campbell M66,  Kiss C67,  Basso G68,  Dworzak MN69,  On Behalf Of I-Bfm-Flow-Network
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    Abstract

    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-Münster (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.


    KEYWORDS: acute lymphoblastic leukemia, flow cytometry, minimal residual disease, quality control program

    Publikations ID: 34885257
    Quelle: öffnen
     
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