Test Catalog

Test Id : CLLMV

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

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 postchemotherapy or post-bone marrow transplantation

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
FCINT Flow Cytometry Interp, 2-8 Markers 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
FIRST Flow Cytometry, Cell Surface, First No, (Bill Only) Yes
ADD1 Flow Cytometry, Cell Surface, Addl No, (Bill Only) Yes

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

When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.

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

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

When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.

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 (LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies).

Additional Testing Requirements

If cytogenetic tests are also desired, when collecting for this test 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: Blood

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Sodium heparin, EDTA

Specimen Volume: 10 mL

Slides: Include 5- to 10-unstained blood smears, if possible.

Collection Instructions: Do not transfer blood to other containers.

 

Specimen Type: Bone Marrow

Container/Tube: 

Preferred: Yellow top (ACD solution A or B)

Acceptable: Sodium heparin, EDTA

Specimen Volume: 1-5 mL

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

Collection Instructions:

1. Submission of bilateral specimens in not required.

2. Label specimen appropriately (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

Blood: 4 mL

Bone Marrow: 1 mL

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

Gross hemolysis Reject
Gross lipemia OK

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) 72 hours
Refrigerated 72 hours

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 postchemotherapy or post-bone marrow transplantation

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

When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.

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 that is the most common leukemia detected in the western world. It is a disease primarily of adults 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 and CD23.

 

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.

 

Individuals without CLL should not have detectable clonal B cells in the peripheral blood or bone marrow.

 

Patients 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 used in several clinical trials at Mayo Clinic evaluating response to therapies in chronic lymphocytic leukemia (CLL). In total, 421 specimens have been analyzed for CLL minimal residual disease (MRD) with this assay; 316 had MRD present and 105 had no detectable MRD. Of the 316 with MRD, 136 had less than 1.0% MRD with 18 at 0.01% detectable MRD (assay sensitivity). Of the 136, 123 had direct correlations with the routine clinical flow cytometric screening assay. Of those 123 cases, 63 had similar findings by both techniques, while 60 had detectable clonal B cells only with the CLL MRD assay.

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;111:5446-5456

2. Varghese AM, Rawstron AC, Hillmen P: Eradicating minimal residual disease in chronic lymphocytic leukemia: should this be the goal of treatment? Curr Hematol Malig Rep 2010;5:35-44

3. Shanafelt TD: Predicting clinical outcome in CLL: how and why. Hematology Am Soc Hematol Educ Program 2009;421-429

4. Sayala HA, Rawstron AC, Hillmen P: Minimal residual disease assessment in chronic lymphocytic leukaemia. Best Pract Res Clin Haematol 2007;20:499-512

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

6. Moreton P, Kennedy B, Lucas G, et al: Eradication of minimal residual disease in B-cell chronic lymphocytic leukemia after alemtuzumab therapy is associated with prolonged survival. J Clin Oncol 2005;23:2971-2979

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

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

CLLM Panel: CD5, CD19, CD20, CD23, CD38, CD45, and kappa and lambda light chains.(Flow Cytometry in Clinical Diagnosis. Fourth edition. Edited by P Keren, JP McCoy Jr, J Carey. ASCP Press, Chicago, IL, 2007)

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

4 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
CLLMV 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.
CK141 Final Diagnosis 50398-7
CK142 Special Studies 30954-2
CK143 Microscopic Description 22635-7
CK140 CLLMV Result No LOINC Needed

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