Maryalice Stetler-Stevenson1, Bruno Paiva2, Lloyd Stoolman3, Pei Lin4, Jeffrey L Jorgensen5, Alberto Orfao6, Jacques Van Dongen7, Andy C Rawstron8. 1. Laboratory of Pathology, NCI, NIH, Bethesda, Maryland, 20892. 2. Clinica Universidad De Navarra, Centro De Investigaciones Medicas Aplicadas (CIMA), IDISNA, Pamplona, SpainAv. Pio XII 55, Pamplona, Spain. 3. Department of Pathology, University of Michigan Health System, Ann Arbor, Michigan, 48109. 4. Department of Hematopathology, MD Anderson Cancer Center, Houston, Texas, 77030. 5. Department of Hematopathology, U.T, M.D. Anderson Cancer Center, Houston, Texas, 77030. 6. Cancer Research Center (IBMCC-CSIC/USAL) and Cytometry Service, Department of Medicine, University of Salamanca-IBSAL, Salamanca, Spain. 7. Department of Immunology, Erasmus Medical Center, Rotterdam, The Netherlands. 8. HMDS, Department of Haematology, St, James's Institute of Oncology, Leeds, Ls9, 7TF, United Kingdom.
Abstract
BACKGROUND: Flow cytometric (FC) detection of minimal residual disease (MRD) in multiple myeloma (MM) is prognostic and predictive of response to therapy. Therefore, standardization of FC MM MRD testing is vital to ensure better and uniform assessment of response to therapy and clinical prognostication. The International Clinical Cytometry Society and European Society for Clinical Cell Analysis, recognizing the need for standardized FC approaches, organized a working group to develop consensus guidelines on good clinical practice in FC MM MRD. Consensus guidelines are presented for specimen quality, staining process, reagent combinations, and the data acquisition process, all key factors in achieving high quality FC MM MRD testing. METHODS: A group of eight flow cytometrists currently performing FC testing in MM evaluated available literature on FC MM MRD testing. A document presenting best practice was developed and reviewed in successive rounds until consensus was reached. RESULTS/ CONCLUSION: The consensus on best practice for detection of MRD in MM is that CD38, CD138, and CD45 are analyzed in combination with CD19, CD56, CD27, CD81, and CD117. Consensus guidelines on acceptable specimen quality, staining procedures, panel design, and data acquisition were developed.
BACKGROUND: Flow cytometric (FC) detection of minimal residual disease (MRD) in multiple myeloma (MM) is prognostic and predictive of response to therapy. Therefore, standardization of FC MM MRD testing is vital to ensure better and uniform assessment of response to therapy and clinical prognostication. The International Clinical Cytometry Society and European Society for Clinical Cell Analysis, recognizing the need for standardized FC approaches, organized a working group to develop consensus guidelines on good clinical practice in FC MM MRD. Consensus guidelines are presented for specimen quality, staining process, reagent combinations, and the data acquisition process, all key factors in achieving high quality FC MM MRD testing. METHODS: A group of eight flow cytometrists currently performing FC testing in MM evaluated available literature on FC MM MRD testing. A document presenting best practice was developed and reviewed in successive rounds until consensus was reached. RESULTS/ CONCLUSION: The consensus on best practice for detection of MRD in MM is that CD38, CD138, and CD45 are analyzed in combination with CD19, CD56, CD27, CD81, and CD117. Consensus guidelines on acceptable specimen quality, staining procedures, panel design, and data acquisition were developed.
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