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
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
FCINT | Flow Cytometry Interp, 2-8 Markers | No, (Bill Only) | No |
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 |
When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.
Immunophenotyping
When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.
Varies
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).
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.
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)
If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Blood: 4 mL
Bone Marrow: 1 mL
Gross hemolysis | Reject |
Gross lipemia | OK |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Ambient (preferred) | 72 hours | |
Refrigerated | 72 hours |
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
When this test is ordered, flow cytometry interpretation, 2 to 8 markers will be performed at an additional charge.
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.
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.
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.
This test is only appropriate for patients who have a previously confirmed diagnosis of chronic lymphocytic leukemia.
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.
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
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)
Monday through Saturday
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.
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
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 |