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Test Code MRDMR Multiple Myeloma Minimal Residual Disease by Flow Cytometry, Bone Marrow


Specimen Required


Only orderable as a reflex. For more information see MSMRD / Myeloma Stratification and Risk-Adapted Therapy with Reflex to Minimal Residual Disease, Bone Marrow

 

Specimen Type: Redirected bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA)

Specimen Volume: 4 mL


Secondary ID

616031

Useful For

Detecting low level (minimal residual disease) myeloma cells after therapy to confirm remission has been achieved

Disease States

  • Amyloidosis

Method Name

Only orderable as a reflex. For more information see MSMRD / Myeloma Stratification and Risk-Adapted Therapy with Reflex to Minimal Residual Disease, Bone Marrow

 

Immunophenotyping

Reporting Name

Multiple Myeloma MRD by Flow, BM

Specimen Type

Bone Marrow

Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Bone Marrow Ambient (preferred) 72 hours
  Refrigerated  72 hours

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

Multiple myeloma is an incurable malignant neoplasm of plasma cells. One of the best prognostic factors in multiple myeloma is the level of minimal residual disease post chemotherapy or autologous stem cell transplantation. The greater depth of the response (less malignant cells present), the longer time to progression and overall survival.(1)

Reference Values

Only orderable as a reflex. For more information see MSMRD / Myeloma Stratification and Risk-Adapted Therapy with Reflex to Minimal Residual Disease, Bone Marrow

 

An interpretive report will be provided.

Interpretation

The interpretation of the test is done by evaluating automated and manually gated populations to isolate abnormal plasma cells. If there is an abnormal plasma cell population (cluster of 20 cells or more), then the result is minimal residual disease (MRD)-positive, with the percentage of abnormal plasma cells out of total analyzed events. If no abnormal population is found, then the result will be interpreted as MRD-negative.

 

This test will be processed as a laboratory consultation. An interpretation of the immunophenotypic findings and correlation with the previous patient history will be provided by a hematopathologist for every case.

Cautions

There are situations in which current gating strategies are insufficient to identify abnormal plasma cells. This can occur if the abnormal plasma cells do not phenotypically differ from normal plasma cells. In addition, in patients who have undergone therapeutic antibody treatment (anti-CD38, for example), decreased antigen expression on plasma cells may interfere with the gating strategy.

Clinical Reference

1. Martinez-Lopez J, Lahuerta JJ, Pepin F, et al. Prognostic value of deep sequencing method for minimal residual disease detection in multiple myeloma. Blood. 2014 May;123(20):3073-3079

2. Rawstron AC, Child JA, de Tute RM, et al. Minimal residual disease assessed by multiparameter flow cytometry in multiple myeloma: impact on outcome in the medical research council myeloma IX Study. J Clin Oncol. 2013;31(20):2540-2547

3. Roschewski M, Stetler-Stevenson M, Yuan C, et al. Minimal residual disease: What are the minimum requirements? J Clin Oncol. 2014 Feb 10;32(5):475-476

4. Stetler-Stevenson M, Paiva B, Stoolman L, et al. Consensus guidelines for myeloma minimal residual disease sample staining and data acquisition. Cytometry B Clin Cytom. 2016;90(1):26-30 doi: 10.1002/cyto.b.21249

5. Callander NS, Baljevic M, Adekola K, et al. NCCN Guidelines Insights: Multiple Myeloma, Version 3.2022. J Natl Compr Canc Netw. 2022;20(1):8-19. doi:10.6004/jnccn.2022.0002

Method Description

Flow cytometric immunophenotyping for minimal residual disease (MRD) of bone marrow is performed using the following antibodies:

Tube 1: CD138, CD27, CD38, CD56, CD45, CD19, CD117, and CD81.

Tube 2: CD138, CD27, CD38, CD56, CD45, CD19, cyKappa, and cyLambda.

Abnormal plasma cell populations are detected through demonstrating CD38 (multi-epitope) and CD138 positivity along with immunoglobulin light chain restriction (ie, the presence of either predominately kappa or lambda immunoglobulin light chains) and abnormality of CD56, CD117, CD27, CD81, CD19 and/or CD45 expression.

 

The sensitivity of this assay is conservatively estimated to be 0.001% (1 x 10[-5]) with a minimum number of 2 x 10(-6) total events collected, and an abnormal plasma cell immunophenotype detected in a cluster of at least 20 cells and can be as high as 0.0002% (2 x 10[-6]). The sensitivity of the assay will be lower in samples with less than 2 x 10(-6) total events acquired. The validated limit of detection (sensitivity) meets the current National Comprehensive Cancer Network, International Myeloma Working Group, and EuroFlow guidelines for MRD assessment by flow cytometry in multiple myeloma. The percentage of clonal plasma cells estimated by flow cytometry is affected by specimen processing and antigen loss with specimen aging. MRD reporting is affected by sample volume and cellularity.(Unpublished Mayo method)

Day(s) Performed

Preanalytical processing: Monday through Saturday

Results reported: Monday through Friday

Report Available

2 to 4 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88184-Flow Cytometry; first cell surface, cytoplasmic or nuclear marker

88185 x 9-Flow Cytometry; additional cell surface, cytoplasmic or nuclear marker

88188-Flow Cytometry Interpretation, 9 to 15 Markers

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MRDMR Multiple Myeloma MRD by Flow, BM 93022-2

 

Result ID Test Result Name Result LOINC Value
CK146 % Minimal Residual Disease (MRD) 93021-4
CK147 % Normal Plasma Cells (of total PC) 93020-6
CK148 Non-Aggregate Events 38257-2
CK149 Total Plasma Cell Events 93019-8
CK150 Poly PC Events 93018-0
CK151 Abnormal PC Events 93017-2
615796 % B-cell Precursors 101131-1
615797 % Mast Cells 101130-3
616082 Validated Assay Sensitivity 101129-5
616083 Lower Limit of Quantitation (LLOQ) 87706-8
615798 Patient / Sample Theoretical LOQ 101128-7
614590 Final Diagnosis 74226-2

Highlights

This is a high-sensitivity flow cytometry test for detection of minimal residual myeloma cells, post treatment.

 

It uses adopted EuroFlow guidelines and Cytognos software.

 

It has a sensitivity of 10(-5) or better, depending on the antigenic profile of abnormal plasma cells.