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Assessment of plasma cell myeloma minimal residual disease testing by flow cytometry in an international

Stuart D Scott1,2, Matthew Fletcher1, Helen Whitehouse1

  • 1UK NEQAS for Leucocyte Immunophenotyping, Sheffield Teaching Hospitals, Sheffield, UK.

Cytometry. Part B, Clinical Cytometry
|December 20, 2018
PubMed
Abstract

Insights

Standardized flow cytometry (FC) testing for minimal residual disease (MRD) in plasma cell myeloma (PCM) shows promise as a clinical endpoint. While generally accurate, further standardization can reduce inter-laboratory variation in MRD detection.

Area of Science:

  • Hematology
  • Clinical Cytometry
  • Oncology

Background:

  • Minimal/measurable residual disease (MRD) testing by flow cytometry (FC) is a potential surrogate endpoint for plasma cell myeloma (PCM) clinical trials.
  • Standardization efforts are underway to refine FC MRD testing in PCM patients.

Purpose of the Study:

  • To assess inter-laboratory variation in FC MRD testing for PCM patients.
  • To evaluate the performance of standardized FC assays in detecting neoplastic plasma cells (PCs).

Main Methods:

  • Ten international laboratories participated in a blind inter-laboratory study.
  • A dilution series of bone marrow samples with known percentages of neoplastic PCs (0% to 0.0001%) were tested using standardized FC PCM MRD assays.

Main Results:

  • Laboratories' assays generally adhered to consensus guidelines, with some deviations noted.
  • All participating laboratories detected neoplastic PCs down to 0.001%, and most (6/8) detected them at 0.0001%.
  • Quantitative data showed good consensus and linearity, though variation increased at lower MRD levels; analytical and post-analytical errors were identified.

Conclusions:

  • Broadly standardized PCM MRD FC assays can achieve the required lower limit of detection for clinical trials.
  • Assay linearity supports survival prediction based on PC reduction, but further standardization is needed to minimize inter-laboratory variation.
Keywords:
flow cytometryminimal residual disease (MRD)myelomaquality control

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