Assessment of plasma cell myeloma minimal residual disease testing by flow cytometry in an international inter-laboratory study: Is it ready for primetime use?

摘要: BACKGROUND Minimal/measurable residual disease (MRD) testing by flow cytometry (FC) has been proposed as a potential surrogate clinical endpoint in plasma cell myeloma (PCM) trials. As result, effort gone into standardizing this approach on PCM patients. AIMS To assess inter-laboratory variation FC MRD of patients an independent study. METHODS A dilution series five stabilized bone marrow samples manufactured to contain 0%, 0.1%, 0.01%, 0.001%, and 0.0001% neoplastic cells (PCs) were tested blind, using standardized assays 10 international laboratories. RESULTS Laboratories' broadly adhered the consensus guidelines; however, some deviations identified panel design, fluorochrome conjugates, lysis reagents. Despite this, all laboratories that returned results detected PCs down 0.001% leucocytes. 6/8 at level 0.0001%. Quantitative data showed good linearity with increasing lower levels MRD. However, examples analytical post error identified. SUMMARY/CONCLUSION Broadly can attain limit detection (LOD) required current future trials, important consideration establishing marker linearity, encouraging prediction survival based log reduction PC populations from guidelines study would suggest if are further interlaboratory could be reduced. © 2018 International Clinical Cytometry Society.