TY - JOUR
T1 - Analysis of measurable residual disease by IG/TR gene rearrangements
T2 - quality assurance and updated EuroMRD guidelines
AU - van der Velden, Vincent H.J.
AU - Dombrink, Isabel
AU - Alten, Julia
AU - Cazzaniga, Giovanni
AU - Clappier, Emmanuelle
AU - Drandi, Daniela
AU - Eckert, Cornelia
AU - Fronkova, Eva
AU - Hancock, Jeremy
AU - Kotrova, Michaela
AU - Kraemer, Rebekka
AU - Montonen, Mirkka
AU - Pfeifer, Heike
AU - Pott, Christiane
AU - Raff, Thorsten
AU - Trautmann, Heiko
AU - Cavé, Hélène
AU - Schäfer, Beat W.
AU - van Dongen, Jacques J.M.
AU - EuroMRD Consortium
AU - Trka, Jan
AU - Brüggemann, Monika
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/6/1
Y1 - 2024/6/1
N2 - Minimal/measurable residual disease (MRD) diagnostics using real-time quantitative PCR analysis of rearranged immunoglobulin and T-cell receptor gene rearrangements are nowadays implemented in most treatment protocols for patients with acute lymphoblastic leukemia (ALL). Within the EuroMRD Consortium, we aim to provide comparable, high-quality MRD diagnostics, allowing appropriate risk-group classification for patients and inter-protocol comparisons. To this end, we set up a quality assessment scheme, that was gradually optimized and updated over the last 20 years, and that now includes participants from around 70 laboratories worldwide. We here describe the design and analysis of our quality assessment scheme. In addition, we here report revised data interpretation guidelines, based on our newly generated data and extensive discussions between experts. The main novelty is the partial re-definition of the "positive below quantitative range" category by two new categories, "MRD low positive, below quantitative range" and "MRD of uncertain significance". The quality assessment program and revised guidelines will ensure reproducible and accurate MRD data for ALL patients. Within the Consortium, similar programs and guidelines have been introduced for other lymphoid diseases (e.g., B-cell lymphoma), for new technological platforms (e.g., digital droplet PCR or Next-Generation Sequencing), and for other patient-specific MRD PCR-based targets (e.g., fusion genes).
AB - Minimal/measurable residual disease (MRD) diagnostics using real-time quantitative PCR analysis of rearranged immunoglobulin and T-cell receptor gene rearrangements are nowadays implemented in most treatment protocols for patients with acute lymphoblastic leukemia (ALL). Within the EuroMRD Consortium, we aim to provide comparable, high-quality MRD diagnostics, allowing appropriate risk-group classification for patients and inter-protocol comparisons. To this end, we set up a quality assessment scheme, that was gradually optimized and updated over the last 20 years, and that now includes participants from around 70 laboratories worldwide. We here describe the design and analysis of our quality assessment scheme. In addition, we here report revised data interpretation guidelines, based on our newly generated data and extensive discussions between experts. The main novelty is the partial re-definition of the "positive below quantitative range" category by two new categories, "MRD low positive, below quantitative range" and "MRD of uncertain significance". The quality assessment program and revised guidelines will ensure reproducible and accurate MRD data for ALL patients. Within the Consortium, similar programs and guidelines have been introduced for other lymphoid diseases (e.g., B-cell lymphoma), for new technological platforms (e.g., digital droplet PCR or Next-Generation Sequencing), and for other patient-specific MRD PCR-based targets (e.g., fusion genes).
UR - http://www.scopus.com/inward/record.url?scp=85193725140&partnerID=8YFLogxK
U2 - 10.1038/s41375-024-02272-0
DO - 10.1038/s41375-024-02272-0
M3 - Article
C2 - 38744919
AN - SCOPUS:85193725140
SN - 0887-6924
VL - 38
SP - 1315
EP - 1322
JO - Leukemia
JF - Leukemia
IS - 6
ER -