Journal
DIAGNOSTICS
Volume 11, Issue 10, Pages -Publisher
MDPI
DOI: 10.3390/diagnostics11101872
Keywords
multiple myeloma; minimal residual disease; flow cytometry
Categories
Funding
- Polish Myeloma Consortium
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The study demonstrates high reproducibility of using high-sensitivity flow cytometry for MM MRD assessment, with EuroFlow protocol confirmed as an effective method. Both inter-laboratory and inter-operator studies showed high concordance, but differences were noticed in immunophenotype interpretation of CD27, CD45, CD81.
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.
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