Test Id : CSPMM
Plasma Cell Myeloma Pre-Analysis Cell Sorting, Bone Marrow
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Pre-analysis cell sorting for the MayoComplete Plasma Cell Myeloma panel
    
        Method Name
            
                
                
                    
                    A short description of the method used to perform the test
                
            
    
    Only orderable as a reflex. For more information see NGPCM / MayoComplete Plasma Cell Myeloma, Next-Generation Sequencing, Varies.
Flow Cytometric Cell Selection
    
        NY State Available
            
                
                
                    
                    Indicates the status of NY State approval and if the test is orderable for NY State clients.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        Bone Marrow
    
        Specimen Required
            
                
                
                    
                    Defines the optimal specimen required to perform the test and the preferred volume to complete testing
                
            
    
    Only orderable as a reflex. For more information see NGPCM / MayoComplete Plasma Cell Myeloma, Next-Generation Sequencing, Varies.
Specimen Type: Bone marrow aspirate
Container/Tube: Lavender or pink top (EDTA) or yellow top (ACD)
Specimen Volume: 2 mL
Collection Instructions:
1. Minimum plasma cell percentage is 5%.
2. Invert several times to mix bone marrow.
3. Send bone marrow specimen in original tube. Do not aliquot.
4. Label specimen as bone marrow.
5. Fresh specimen is required for this test, as testing is performed on sorted cells.
Specimen Stability Information: Ambient (preferred) 4 days/Refrigerate
    
        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
                
            
    
    | Gross hemolysis | Reject | 
| Gross lipemia | OK | 
| Fully clotted | Reject | 
| Bone marrow biopsies Slides Paraffin shavings Frozen tissues Paraffin-embedded tissues Paraffin-embedded bone marrow aspirates Extracted DNA | Reject | 
    
        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 | 4 days | 
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Pre-analysis cell sorting for the MayoComplete Plasma Cell Myeloma panel
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    Testing allows for further risk categorization of multiple myeloma (MM) through identifying additional abnormalities of prognostic and, potentially, therapeutic value. Application of targeted next-generation sequencing-based analysis is a useful adjunct to the standard evaluation of MM patients at diagnosis and relapse.
    
        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.
                
            
    
    Only orderable as a reflex. For more information see NGPCM / MayoComplete Plasma Cell Myeloma, Next-Generation Sequencing, Varies.
Not applicable
    
        Interpretation
            
                
                
                    
                    Provides information to assist in interpretation of the test results
                
            
    
    Correlation with clinical, histopathologic, and additional laboratory findings is required for final interpretation of these results. The final interpretation of results for clinical management of the patient is the responsibility of the managing physician.
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    No significant cautionary statements
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Walker BA, Boyle EM, Wardell CP, et al. Mutational spectrum, copy number changes, and outcome: results of a sequencing study of patients with newly diagnosed myeloma. J Clin Oncol. 2015;33(33):3911-3920
2. Morgan GJ, Walker BA, Davies FE. The genetic architecture of multiple myeloma. Nat Rev Cancer. 2012;12(5):335-348
3. Kortuem KM, Braggio E, Bruins L, et al. Panel sequencing for clinically oriented variant screening and copy number detection in 142 untreated multiple myeloma patients. Blood Cancer J. 2016;6(2):e397
4. Kortuem KM, Mai EK, Hanafiah NH, et al. Targeted sequencing of refractory myeloma reveals a high incidence of mutations in CRBN and Ras pathway genes. Blood. 2016;128(9):1226-1233
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    Selection of plasma cells using fluorescence-activated cell sorting is the most direct and robust method of obtaining relatively pure plasma cell populations for molecular assessment. This, in turn, augments the ability to identify key mutations and subclonal variants of possible clinical value without dilution effects from non-tumor cell DNA.(Instruction manual: BD FACSMelody Cell Sorter User's Guide. Revision 3. BD Biosciences; 03/2020)
    
        PDF Report
            
                
                
                    
                    Indicates whether the report includes an additional document with charts, images or other enriched information
                
            
    
    
    
        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.
                
            
    
    Monday through Saturday
    
        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.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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.
                
            
    
    CPT codes are provided by the performing laboratory.
88184-Flow Cytometry; first cell surface, cytoplasmic or nuclear marker
88185 x 5-Flow Cytometry, additional cell surface, cytoplasmic or nuclear marker (each)
    
        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 | 
|---|---|---|
| CSPMM | NGPCM Pre-Analysis Cell Sorting, BM | No LOINC Needed | 
| 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.
                                     | 
|---|---|---|
| 618627 | NGPCM Pre-Analysis Cell Sort | No LOINC Needed | 
| 618630 | Final Diagnosis | 22637-3 |