Test Catalog

Test Id : MYEFL

Myelodysplastic Syndrome by Flow Cytometry, Bone Marrow

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

Detecting increased blasts

 

Characterizing blast phenotypes

 

Identifying abnormal patterns of myeloid maturation as seen in myelodysplastic syndromes and other clonal myeloid neoplasms

 

Providing additional adjunct diagnostic information in cases with equivocal or suspicious morphologic features for myelodysplastic syndrome (MDS), MDS/myeloproliferative neoplasms including chronic myelomonocytic leukemia, and other clonal myeloid neoplasms

Highlights

This assay, when used in combination with appropriate review of the clinical history, morphologic, cytogenetic, and molecular genetic data, may provide helpful diagnostic information in evaluating bone marrow specimens for possible involvement by a myelodysplastic syndrome (MDS) or a myelodysplastic/myeloproliferative neoplasm (MDS/MPN) including chronic myelomonocytic leukemia (CMML).

 

In addition to detecting increased blasts, this assay also analyzes blast phenotypes and patterns of myeloid maturation. The diagnostic contribution of this assay, thus, does not rely solely on identifying blast increases.

 

This assay is not intended for prognostication or monitoring of response to therapy.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
FCINS Flow Cytometry Interp,16 or greater No, (Bill Only) No

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
ADD1 Flow Cytometry, Cell Surface, Addl No, (Bill Only) Yes
FIRST Flow Cytometry, Cell Surface, First No, (Bill only) Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This assay uses 2 panels for identifying cell populations of interest and for characterizing their phenotypic features. In the myelodysplastic syndrome panel, blasts are identified by CD45/side scatter gating strategy and by CD34 expression; promyelocytes are identified by bright CD13, CD33, and CD117 expression without CD34; granulocytes and precursors are defined by their variable expression of CD13 and CD16 according to their maturational stages. Abnormal patterns of myeloid maturation are determined according to the presence or absence of the following features: distinct blast increases over 5%; heterogeneous blast distribution on CD13/HLA-DR plot; expression of CD2, CD7, and/or CD56 on blasts; and disrupted granulocytic maturation on CD13/CD16 plot.(1,2)

 

Additionally, a triage panel is performed to ensure that monotypic B-cells, increased plasma cells, and phenotypically aberrant populations of CD3-positive T-cells and CD16-positive/CD3-negative natural killer (NK) cells, if present, are identified. This is necessary especially for cases where the reason for referral is broad, where clonal myeloid neoplasms may not be the only diagnostic consideration, or where there is incomplete clinical history and morphologic data.

 

These panels are used in combination with any available provided clinical history and morphologic findings to determine if any additional testing may be needed for complete disease characterization. If such additional testing is required, it will be added according to laboratory algorithms at an additional charge per unique antibody tested.

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

Immunophenotyping

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

MDS by Flow Cytometry, BM

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This assay uses 2 panels for identifying cell populations of interest and for characterizing their phenotypic features. In the myelodysplastic syndrome panel, blasts are identified by CD45/side scatter gating strategy and by CD34 expression; promyelocytes are identified by bright CD13, CD33, and CD117 expression without CD34; granulocytes and precursors are defined by their variable expression of CD13 and CD16 according to their maturational stages. Abnormal patterns of myeloid maturation are determined according to the presence or absence of the following features: distinct blast increases over 5%; heterogeneous blast distribution on CD13/HLA-DR plot; expression of CD2, CD7, and/or CD56 on blasts; and disrupted granulocytic maturation on CD13/CD16 plot.(1,2)

 

Additionally, a triage panel is performed to ensure that monotypic B-cells, increased plasma cells, and phenotypically aberrant populations of CD3-positive T-cells and CD16-positive/CD3-negative natural killer (NK) cells, if present, are identified. This is necessary especially for cases where the reason for referral is broad, where clonal myeloid neoplasms may not be the only diagnostic consideration, or where there is incomplete clinical history and morphologic data.

 

These panels are used in combination with any available provided clinical history and morphologic findings to determine if any additional testing may be needed for complete disease characterization. If such additional testing is required, it will be added according to laboratory algorithms at an additional charge per unique antibody tested.

Specimen Type
Describes the specimen type validated for testing

Bone Marrow

Additional Testing Requirements

If cytogenetic tests are also desired when collecting MYEFL / Myelodysplastic Syndrome by Flow Cytometry, Bone Marrow, an additional specimen should be submitted. It is important that the specimen be obtained, processed, and transported according to instructions for the other required test.

Shipping Instructions

Specimen must be received within 72 hours.

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

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Heparin, EDTA

Specimen Volume: 2-5 mL

Slides: Include 5 to 10 unstained bone marrow aspirate smears, if possible.

Collection Instructions:

1. Submission of bilateral specimens is not required.

2. Label specimen as bone marrow.

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

1 mL

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

Gross hemolysis 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 (preferred)

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

Detecting increased blasts

 

Characterizing blast phenotypes

 

Identifying abnormal patterns of myeloid maturation as seen in myelodysplastic syndromes and other clonal myeloid neoplasms

 

Providing additional adjunct diagnostic information in cases with equivocal or suspicious morphologic features for myelodysplastic syndrome (MDS), MDS/myeloproliferative neoplasms including chronic myelomonocytic leukemia, and other clonal myeloid neoplasms

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This assay uses 2 panels for identifying cell populations of interest and for characterizing their phenotypic features. In the myelodysplastic syndrome panel, blasts are identified by CD45/side scatter gating strategy and by CD34 expression; promyelocytes are identified by bright CD13, CD33, and CD117 expression without CD34; granulocytes and precursors are defined by their variable expression of CD13 and CD16 according to their maturational stages. Abnormal patterns of myeloid maturation are determined according to the presence or absence of the following features: distinct blast increases over 5%; heterogeneous blast distribution on CD13/HLA-DR plot; expression of CD2, CD7, and/or CD56 on blasts; and disrupted granulocytic maturation on CD13/CD16 plot.(1,2)

 

Additionally, a triage panel is performed to ensure that monotypic B-cells, increased plasma cells, and phenotypically aberrant populations of CD3-positive T-cells and CD16-positive/CD3-negative natural killer (NK) cells, if present, are identified. This is necessary especially for cases where the reason for referral is broad, where clonal myeloid neoplasms may not be the only diagnostic consideration, or where there is incomplete clinical history and morphologic data.

 

These panels are used in combination with any available provided clinical history and morphologic findings to determine if any additional testing may be needed for complete disease characterization. If such additional testing is required, it will be added according to laboratory algorithms at an additional charge per unique antibody tested.

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

Myelodysplastic syndromes (MDS) encompass a heterogeneous group of clonal hematopoietic neoplasms characterized by cytopenias due to ineffective hematopoiesis, variable degrees of dysmyelopoietic morphologic features, and increased risks of evolution to acute myeloid leukemia. Per 2008 World Health Organization recommendations, a definitive diagnosis of MDS requires identification of 1 or more of the following findings: clear-cut morphologic features of dysplasia in greater than or equal to 10% of the cells in 1 or more of the 3 hematopoietic lineages; increased (but <20%) blood or marrow blasts with or without Auer rods; and well-characterized clonal cytogenetic abnormalities.(3-4) 

 

However, at present, in approximately 50% of MDS patients, no informative or diagnostic clonal cytogenetic abnormalities are identified. Not infrequently, morphologic review of the patient’s blood and marrow specimen is inconclusive. And yet it is important to distinguish MDS and other clonal myeloid neoplasms from other nonmalignant and nonneoplastic possibilities in the differential diagnosis such as medication effects or other toxic exposures, copper deficiency, infections, and left-shifted hematopoietic regeneration, among others.  

 

In such settings, when used in conjunction with appropriate clinical and morphologic findings, flow cytometry immunophenotyping analysis can provide additional diagnostic information to help distinguish an underlying clonal hematopoietic neoplasm from a reactive or secondary response.(2,5)

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. This test will be processed as a laboratory consultation. An interpretation of the immunophenotypic findings and, if available, morphologic features will be provided by a board-certified hematopathologist for every case.

Interpretation
Provides information to assist in interpretation of the test results

The final interpretation integrates 1) the quantity of blasts; 2) blast phenotype with respect to CD13/HLA-DR expression and/or abnormal coexpression of CD2, CD7, and/or CD56; and 3) myeloid maturation patterns based on CD13/CD16 plot. In combination, the total number of abnormalities detected and the distinctiveness of the abnormalities themselves help determine the likelihood of specimen involvement by a clonal myeloid neoplasm.

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

The results of this assay are not intended to be stand-alone and need to be correlated with the patient’s clinical history, findings from the primary morphologic review of blood and marrow slides, and other laboratory features including cytogenetic and molecular genetic results.

 

The quantity of blasts as identified and reported in this assay should not form the basis upon which the final diagnosis or subclassification of acute myeloid leukemia, myelodysplastic syndrome, myeloproliferative neoplasms, or myelodysplastic/myeloproliferative neoplasms is established. For that purpose, the percentage of blasts derived from a morphologic review of the primarily prepared blood and marrow slides is required; per 2008 World Health Organization guidelines (If unable to perform at the client site, order PATHC / Pathology Consultation).

 

This assay should not be used to monitor response to therapy.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Kussick SJ, Fromm JR, Rossini A, et al: Four-color flow cytometry shows strong concordance with bone marrow morphology and cytogenetics in the evaluation for myelodysplasia. Am J Clin Pathol 2005;124:170-181

2. Jevremovic D, Timm MM, Reichard KK, et al: Loss of blast heterogeneity in myelodysplastic syndrome and other chronic myeloid neoplasms. Am J Clin Pathol 2014;142:292-298

3. Brunning RD, Orazi A, Germing U, LeBeau MM: WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. Edited by SH Swerdlow, E Campo, NL Harris, et al. IARC Lyon, 2008, pp 88-107 

4. Cioc AM, Nguyen PL: Myelodysplastic syndromes. In Hematopathology. Edited by E Hsi. Elsevier Saunders. Philadelphia, 2012, pp 523-546

5. van de Loosdrecht AA, Westers TM: Cutting edge: flow cytometry in myelodysplastic syndromes. J Natl Compr Canc Netw 2013;11:892-902

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

Flow cytometry immunophenotyping of bone marrow is performed using the following antibodies:

Myelodysplastic Syndrome Panel: CD2, CD7, CD10, CD13, CD15, CD16, CD33, CD34, CD36, CD38, CD45, CD56, CD64, CD117, and HLA-DR

 

Triage Panel: CD3, CD10, CD16, CD19, CD34, CD45, and kappa and lambda immunoglobulin light chains.(Unpublished Mayo methods)

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.

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.

1 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

Remaining bone marrow, 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 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.

This test was developed using an analyte specific reagent. Its performance characteristics were 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.

88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker x 1

88185-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each) x18

88189-Flow Cytometry Interpretation, 16 or More Markers (if appropriate)

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
MYEFL MDS by Flow Cytometry, BM In Process
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.
CK086 MDS Panel No LOINC Needed
CK092 Final Diagnosis 22637-3
CK093 Special Studies 30954-2
CK094 Microscopic Description 22635-7

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 | Create a 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