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Test Code CLLMD Chronic Lymphocytic Leukemia (CLL) Monitoring Minimal Residual Disease Detection, Flow Cytometry, 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


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.


Secondary ID

608972

Useful For

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

Immunophenotyping

Specimen Type

Varies

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 4 days
  Refrigerated  4 days

Reject Due To

Gross hemolysis Reject
Fully clotted whole blood Reject

Reference Values

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

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.

Method Description

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

Day(s) Performed

Preanalytical processing: Monday through Saturday

Results reported: Monday through Friday

Report Available

1 to 4 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

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 Code Information

Test ID Test Order Name Order LOINC Value
CLLMD CLL Monitoring MRD Detection, V In Process

 

Result ID Test Result Name Result LOINC Value
608973 CLLMD Result No LOINC Needed
608974 Final Diagnosis 22637-3
608975 Special Studies 30954-2
608976 Microscopic Description 22635-7

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.