Test Catalog

Test Id : MRDMM

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Multiple Myeloma Minimal Residual Disease, Flow Cytometry, Bone Marrow

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting low level (minimal residual disease) myeloma cells after therapy.

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 analysis software.

 

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

Method Name
A short description of the method used to perform the test

Immunophenotyping for Minimal Residual Disease (MRD)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Multiple Myeloma MRD by Flow, BM

Aliases
Lists additional common names for a test, as an aid in searching

Multiple Myeloma MRD

Myeloma MRD

Plasma cell MRD

Specimen Type
Describes the specimen type validated for testing

Bone Marrow

Ordering Guidance

This test should be ordered on patients treated for multiple myeloma to confirm remission has been achieved, annual follow-up of those in remission, or in uncertain remission.

 

This test should not be ordered on known relapsing patients or at diagnosis. For these situations or if fluorescence in situ hybridization is requested, order either PCPRO / Plasma Cell DNA Content and Proliferation, Bone Marrow or MSMRT / Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy Report, Bone Marrow

Shipping Instructions

It is recommended that specimens arrive within 2 days of collection. Collect and package specimen as close to shipping time as possible.

Necessary Information

1. Include patient's disease state (untreated, treated, monoclonal gammopathy of undetermined significance, stable).

2. Indicate if patient is on anti-CD38 therapy.

3. Provide Immunofix information if available.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Redirected bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA)

Specimen Volume: 4 mL

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen. 

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting low level (minimal residual disease) myeloma cells after therapy.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

 

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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
Recommendations for in-depth reading of a clinical nature

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;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;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
Describes how the test is performed and provides a method-specific reference

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 (multiepitope) 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 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Preanalytical processing: Monday through Saturday

Results reported: Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

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® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
MRDMM Multiple Myeloma MRD by Flow, BM 93022-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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
CK152 Final Diagnosis 74226-2
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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2023-04-14
File Definition - Result ID 2023-02-07