Test Catalog

Test Id : MONOF

Monocyte Repartition by CD14/CD16, Blood

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

Aiding in the diagnosis and monitoring of chronic myelomonocytic leukemia

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

Monocyte Repartition by CD14/CD16,B

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

MONOF

CMML

Monocytes

Monocytosis

Monocyte repartition

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

If cytogenetic tests are also desired 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

Specimens must be received within 72 hours of collection.

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

Container/Tube:

Preferred: Yellow top (ACD solution A or B)
Acceptable: Lavender top (EDTA)
Specimen Volume: 3 mL

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
New York State specimens, <50% viability 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
Whole blood Refrigerated (preferred) 72 hours

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

Aiding in the diagnosis and monitoring of chronic myelomonocytic leukemia

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

Chronic myelomonocytic leukemia (CMML) is a myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndrome characterized by peripheral blood monocytosis (absolute monocyte count > or =1.0 x 10(9)/L, > or =10% of the total white blood cell count) persisting for 3 months or greater. It could be very challenging to distinguish CMML from a reactive monocytosis or from a MPN (such as primary myelofibrosis or polycythemia vera) with monocytosis. Monocytes can be classified into 3 subsets: classical MO1 (CD14+/CD16-), intermediate MO2 (CD14+/CD16+), and non-classical MO3 (CD14-/CD16+) monocytes, with MO1 constituting the major monocyte population (85%) in healthy individuals. Recent reports using multiparametric flow cytometry have demonstrated a characteristic increase in classical monocytes (> or =94%) in CMML patients, thus distinguishing them from other causes of reactive and clonal monocytosis with greater than 90% sensitivity and specificity.(1) This panel is designed to analyze the repartition of monocytes in these patients and to give a semi-quantitative value for the MO1 compartment. This value will aid in the differential diagnosis and monitoring of CMML.

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.

% Monocytes of WBC: 1.0-6.6%

MO1 (classical monocytes): <94.0%

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report describing the classical monocytes (MO1) fraction as either increased or normal will be provided. See Cautions.

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

Typically, an expanded classical monocytes (MO1) fraction has been seen in patients with chronic myelomonocytic leukemia (CMML).(1,2,3) However, it is not diagnostic of CMML. It can be seen in patients with other myeloid neoplasms (eg, myelodysplastic syndrome, myeloproliferative neoplasm, myelodysplastic/myeloproliferative neoplasm, not otherwise specified) or in reactive conditions. A normal MO1 fraction does not rule out a diagnosis of CMML because it may be seen in CMML patients with autoimmune or inflammatory states or post-therapy.

 

Correlation of these flow cytometry results with bone marrow aspirate and biopsy findings, clinical history, and other laboratory features is required for a definitive diagnosis.

Supportive Data

Clinical Sensitivity and Sensitivity:

Thirty-two patients with untreated chronic myelomonocytic leukemia (CMML) were tested. Twenty-five of these patients had a percent classical monocyte (%MO1) result of greater than or equal to 94%(abnormal result), which correlated to a sensitivity of 78%.

 

One hundred one patients with non-CMML hematologic malignancies were also tested. Ninety of these patients had a %MO1 result of less than 94% (normal result), which correlated to a specificity of 89%.

 

In addition, 30 healthy donors also had a %MO1 result of less than 94% (normal result).

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

1. Selimoglu-Buet D, Wagner-Ballon O, Saada V, et al: Characteristic repartition of monocyte subsets as a diagnostic signature of chronic myelomonocytic leukemia. Blood. 2015 Jun 4;125(23):3618-3626. doi: 10.1182/blood-2015-01-620781

2. Pophali PA, Marinelli LM, Ketterling RP, et al: High level MYC amplification in B-cell lymphomas: is it a marker of aggressive disease? Blood Cancer J. 2020 Jan 13;10(1):5. doi: 10.1038/s41408-019-0271-z

3. Patnaik MM, Timm MM, Vallapureddy R, et al: Flow cytometry based monocyte subset analysis accurately distinguishes chronic myelomonocytic leukemia from myeloproliferative neoplasms with associated monocytosis. Blood Cancer J. 2017 Jul 21;7(7):e584. doi: 10.1038/bcj.2017.66

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

Flow cytometric immunophenotyping of peripheral blood is performed to evaluate the percentage of monocytes in the classical (MO1), intermediate (MO2), and non-classical (MO3) compartments. Only the MO1 compartment will be reported. MONOF Panel: CD3, CD7, CD14, CD16, CD24, CD33, CD45, and CD56.(Patnaik MM, Timm MM, Vallapureddy R, et al: Flow cytometry based monocyte subset analysis accurately distinguishes chronic myelomonocytic leukemia from myeloproliferative neoplasms with associated monocytosis. Blood Cancer J. 2017 Jul;7[7]:e584. doi: 10.1038/bcj.2017.66)

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 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.

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

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

88185 x 7-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)

88187-Flow Cytometry Interpretation, 2 to 8 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
MONOF Monocyte Repartition by CD14/CD16,B 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.
610019 % Monocytes of WBC In Process
610020 MO1 (Classical Monocytes) In Process
610023 Final Diagnosis In Process

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