1. Standardized assay for assessment of minimal residual disease in blood, bone marrow and apheresis from patients with plasma cell myeloma.
- Author
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Blum A, Haussmann K, Streitz M, Schlickeiser S, Tietze-Buerger C, Blau IW, and Uharek L
- Subjects
- Blood Component Removal, Cell Line, Tumor, Feasibility Studies, Humans, Multiple Myeloma therapy, Observer Variation, Reference Standards, Reproducibility of Results, Sensitivity and Specificity, Treatment Outcome, Blood Cells pathology, Bone Marrow Cells pathology, Flow Cytometry methods, Multiple Myeloma diagnosis, Neoplasm, Residual diagnosis
- Abstract
The recent advances in myeloma treatment result in significantly better outcomes, defined as increased progression free survival (PFS) and overall survival (OS). Since there is a proven correlation between the extend of response and prolonged survival, there is an urgent need for highly sensitive assays for the detection of minimal residual disease (MRD). Next generation flow cytometry has become a valuable approach for sensitive evaluation of the depth of complete response (CR). Here, we report the diagnostic performance and validation results of a single-tube 9-color panel assay. The validation design included intra-assay analysis measuring accuracy, inter-assay analysis estimating method's linearity and precision and inter-assay analysis evaluating repeatability. Furthermore, in inter-operator analysis assessed the comparability of the result analysis of different operators. Staining stability was evaluated in age-of-stain experiments. Our validation results show that a reliable detection of residual myeloma cells is feasible to a detection level of 10
-5 with a single-tube assay for a variety of materials (peripheral blood, bone marrow and stem cell apheresis). This study establishes highly sensitive, fully standardized approach for MRD detection in myeloma that is ready for implementation in routine diagnostic laboratories.- Published
- 2019
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