Test Catalog

Test Id : CLLMD

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Chronic Lymphocytic Leukemia (CLL) Monitoring Minimal Residual Disease Detection, Flow Cytometry, Varies

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Overview

Test Catalog

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

Confirming the presence or absence of minimal residual disease in patients with known chronic lymphocytic leukemia who are either post-chemo/immunotherapy or post-bone marrow transplant

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

CLL Monitoring MRD Detection, V

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

CLL MRD

Chronic lymphocytic leukemia minimal residual disease

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

The preferred test for evaluating any tissue biopsy for a potential lymphoproliferative disorder is LLPT / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Tissue.

 

The preferred test for a first-time evaluation of a patient with lymphocytosis is a routine flow cytometric assay; see LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies.

Additional Testing Requirements

If cytogenetic tests are desired along with this test request, 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.

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

Submit only 1 of the following specimens:

 

Specimen Type: Whole blood

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA)

Specimen Volume: 6 mL

Slides: If possible, include 5- to 10-unstained blood smears, must be labeled with two unique identifiers.

Collection Instructions:

1. Send whole blood specimen in original tube. Do not aliquot.

2. Label specimen as blood.

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA)

Specimen Volume: 6 mL

Slides: If possible, include 5 to 10 unstained bone marrow aspirate smears, must be labeled with two unique identifiers.

Collection Instructions:

1. Submission of bilateral specimens is not required.

2. Send bone marrow specimen in original tube. Do not aliquot.

3. 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
Fully clotted whole blood 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
Varies Ambient (preferred) 4 days
Refrigerated 4 days

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

Confirming the presence or absence of minimal residual disease in patients with known chronic lymphocytic leukemia who are either post-chemo/immunotherapy or post-bone marrow transplant

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

Chronic lymphocytic leukemia (CLL) is a low-grade, B-cell neoplasm and is the most common leukemia detected in the western world. It is primarily associated with adult patients and may present as a lymphocytosis, be detected as part of a lymphadenopathy evaluation, or be found incidentally in an otherwise asymptomatic patient. The diagnosis of CLL is based on a combination of morphologic features showing primarily small lymphoid cells with coarse chromatin and scant cytoplasm and an immunophenotype of clonal B cells with dim immunoglobulin, dim CD20, and coexpression of CD5, CD22, CD43, and CD200.

 

New therapeutic approaches in CLL have been increasingly successful with some patients showing no or only very minimal residual disease (MRD) in their peripheral blood or bone marrow specimens following a therapeutic course. Immunophenotyping studies are necessary as morphologic features are not sufficient to detect MRD. The absence of MRD is an important prognostic indicator in these patients.

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 correlation with the morphologic features will be provided by a hematopathologist for every case.

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report for presence or absence of minimal residual disease (MRD) for chronic lymphocytic leukemia (CLL) is provided.

 

Patients with CLL post treatment, who have detectable MRD by this assay, are considered to have residual CLL disease.

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

This test is only appropriate for patients who have a previously confirmed diagnosis of chronic lymphocytic leukemia.

Supportive Data

This assay has been compared with the previously validated assay used in several clinical trials at Mayo Clinic to evaluate response to therapies in patients with chronic lymphocytic leukemia. The data showed that this assay has a better analytic sensitivity, especially for patients undergoing anti-CD19 treatment.

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

1. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12):5446-5456

2. Dimier N, Delmar P, Ward C, et al. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018;131(9):955-962

3. Rawstron AC, Fazi C, Agathangelidis A, et al. A complementary role of multiparameter flow cytometry and high-throughput sequencing for minimal residual disease detection in chronic lymphocytic leukemia: An European Research Initiative on CLL study. Leukemia. 2016;30(4):929-936

4. Zent CS, Victoria Wang X, Ketterling RP, et al. A phase II randomized trial comparing standard and low dose rituximab combined with alemtuzumab as initial treatment of progressive chronic lymphocytic leukemia in older patients: a trial of the ECOG-ACRIN Cancer Research Group (E1908). Am J Hematol. 2016;91(3):308-312

5. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib-Rituximab or chemoimmunotherapy for chronic lymphocytic leukemia. N Engl J Med. 2019;381(5):432-443

6. Kay NE, Strati P, LaPlant BR, et al. A randomized phase II trial comparing chemoimmunotherapy with or without bevacizumab in previously untreated patients with chronic lymphocytic leukemia. Oncotarget. 2016;7(48):78269-78280

7. Strati P, Keating MJ, O'Brien SM, et al. Eradication of bone marrow minimal residual disease may prompt early treatment discontinuation in CLL. Blood. 2014;123(24):3727-3732

8. Rawstron AC, Villamor N, Ritgen M, et al. International standardized approach for flow cytometric residual disease monitoring in chronic lymphocytic leukaemia. Leukemia. 2007;21(5):956-964

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

Flow cytometric immunophenotyping (high sensitivity) of bone marrow is performed to evaluate the presence or absence of chronic lymphocytic leukemia (CLL) minimal residual disease (MRD) using the following antibodies:

CLL, MRD Panel: CD5, CD19, CD20, CD22, CD38, CD43, CD45, CD200, and kappa and lambda immunoglobulin light chains.

The sensitivity of this assay is 0.002% (2 x 10[-5]) based on 1,000,000 total events collected and an abnormal cell immunophenotype detected in a cluster of at least 20 cells. The assay sensitivity meets or exceeds the 0.01-0.001% (10[-4]-10[-5]) level of detection by flow cytometry, as recommended by the current ERIC method and NCCN guidelines for MRD analysis in CLL.(Keren P, McCoy Jr JP, Carey J, eds. Flow Cytometry in Clinical Diagnosis. 4th ed. ASCP Press; 2007; Wierda WG, Brown J, Abramson JS, et al. NCCN Guidelines Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 3.2022. J Natl Compr Canc Netw. 2022;20(6):622-634. doi:10.6004/jnccn.2022.0031

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.

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 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 (each)

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
CLLMD CLL Monitoring MRD Detection, V 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.
608973 CLLMD Result No LOINC Needed
608974 Final Diagnosis 22637-3
608975 Special Studies 30954-2
608976 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 | PHP Pdf | CMS 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