| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : MRDMM
Multiple Myeloma Minimal Residual Disease by Flow, Bone Marrow
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Detection of low level (minimal residual disease) myeloma cells after therapy
Highlights
High-sensitivity flow cytometry test for detection of minimal residual myeloma cells, post treatment
Adopted EuroFlow guidelines and Cytognos software
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
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.
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
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
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
Describes the specimen type validated for testing
Bone Marrow
Ordering Guidance
MRDMM should be ordered when monitoring Multiple Myeloma patients after treatment. This test should not be ordered on known relapsing patients or at diagnosis, see PCPRO / Plasma Cell DNA Content and Proliferation, Bone Marrow or MSMRT / Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy Report if indicated for these situations.
Shipping Instructions
It is recommended that specimens arrive within 48 hours of draw. Draw 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
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)
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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
2 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
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
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
Suggests clinical disorders or settings where the test may be helpful
Detection of 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
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.
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.
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.
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
The interpretation of the test is done by an 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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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
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 May 15;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 Jul 10;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. Rawstron AC, Orfao A, Beksac M, et al: Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica 2008 Mar;93(3): 431-438
5. 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 Jan;90(1):26-30 doi: 10.1002/cyto.b.21249
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
Flow cytometric immunophenotyping for minimal residual disease 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 predominately lambda light chains) and abnormality of CD56, CD117, CD27, CD81, CD19 and/or CD45 expression.
The percentage of clonal plasma cells estimated by flow cytometry is affected by specimen processing and antigen loss with specimen aging. Minimal residual disease 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
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.
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.
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.
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
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
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.
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 Regional Manager. 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.
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. This test 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.
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.
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
| Test Id | Test Order Name |
Order LOINC Value
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.
|
|---|---|---|
| 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 |
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.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
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.
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.