Test ID: CLLM
CLL Monitoring, MRD Detection, Blood
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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-chemotherapy or post-bone marrow transplantation
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 88465 | Flow Cytometry Interp, 2-8 Markers | No, (Bill Only) | Yes |
Testing Algorithm Delineates situation(s) 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 always be performed at an additional charge.
Method Name A short description of the method used to perform the test
Flow Cytometric Immunophenotyping
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Yellow top (ACD solution B)
Specimen Volume: 6 mL
Collection Instructions:
1. Do not transfer blood to other containers.
2. Include 5 to 10 unstained blood smears, if possible.
Forms: If not ordering electronically, please submit a Hematopathology/Molecular Oncology Request Form (Supply T241) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | OK |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Whole blood | Ambient (preferred) | |
| Refrigerated | ||
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 previous 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 <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 Provides recommendations for further 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 monoclonal antibodies directed against CD5, CD19, CD20,CD45, and anti-kappa and anti-lambda immunoglobulins.(Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Specimens are processed and reported Monday through Sunday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CLL Monitoring, MRD Detection
88184-Flow cytometry, first cell surface, cytoplasmic or nuclear marker
88185 x 5-Each additional marker
Flow Cytometry Interpretation, 2-8 Markers
88187-Flow cytometry
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 20424 | Accession Number | N/A |
| 20425 | Referring Pathologist/Physician | 46608-6 |
| 20426 | Ref. Path Address | N/A |
| 20427 | Material | N/A |
| 20428 | Specimen: | N/A |
| 20429 | Microscopic Description | N/A |
| 20430 | Special Studies: | N/A |
| 20431 | Final Diagnosis: | N/A |
| 20432 | Comment: | N/A |
| 20433 | Signing Pathologist | 19139-5 |
| 20434 | *Previous Report Follows* | N/A |
| 20435 | Addendum | 35265-8 |
| 20436 | Addendum Comment: | 22638-1 |
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