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Test Code LABALLM B-Cell Lymphoblastic Leukemia Monitoring, Minimal Residual Disease Detection, Flow Cytometry, Varies

Important Note

SPECIMEN MUST ARRIVE WITHIN 72 HOURS OF COLLECTION

Additional Codes

Test Name in Epic EPIC TEST CODE Mnemonic Mayo Test ID
B-ALL MONITORING, MRD DETECTION, MN LABALLM BALLM BALLM

 


Additional Testing Requirements


If cytogenetic tests are also desired 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.



Shipping Instructions


Specimens must be received within 3 days of collection.



Necessary Information


A copy of the diagnostic flow cytometry report is required.



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), green top (sodium heparin)

Specimen Volume: 6 mL

Slides: If possible, include 5 to 10 unstained blood smears labeled with 2 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), green top (sodium heparin)

Specimen Volume: 6 mL

Slides: If possible, include 5 to 10 unstained bone marrow aspirate smears labeled with 2 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.


Useful For

Aids in monitoring a previously confirmed diagnosis of B-cell acute lymphoblastic leukemia

Testing Algorithm

For more information see Acute Leukemias of Ambiguous Lineage Testing Algorithm

Method Name

Immunophenotyping

Reporting Name

B-ALL Monitoring, MRD Detection, V

Specimen Type

Varies

Specimen Minimum Volume

Blood: 2 mL
Bone Marrow: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient 72 hours

Reject Due To

Gross hemolysis Reject

Clinical Information

B-cell acute lymphoblastic leukemia (B-ALL) is a neoplasm of precursor cells (lymphoblasts) committed to B-cell lineage. B-ALL is the most common acute leukemia in children and adolescents and can also occur in adults. Patients with B-ALL typically present with a high blast count in the peripheral blood and bone marrow replacement with the disease. The diagnosis of B-ALL is based on a combination of morphologic features showing primarily small blasts with open chromatin and high N:C ratio, and an immunophenotype showing immaturity (CD34 and/or TdT expression) associated with B-cell lineage markers (CD19, CD22, and CD79a).

 

New therapeutic approaches in B-ALL have been increasingly successful. One of the most important predictors of the disease relapse is the ability to detect minimal residual disease (MRD) in the bone marrow specimens following induction phase of the therapy (day 28). Immunophenotyping studies are necessary as morphologic features are not sufficient to detect MRD. The absence of MRD (at 0.002% sensitivity) is an important prognostic indicator in these patients.

 

This test may also be used to establish an immunophenotypic fingerprint of tumor cells at diagnosis to monitor MRD in these patients after treatments or allogeneic stem cell transplant.

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 the presence or absence of B-cell acute lymphoblastic leukemia (B-ALL) minimal residual disease (MRD) is provided. Patients who have detectable MRD by this assay are considered to have residual/recurrent B-ALL.

Cautions

This test is only appropriate for patients who have a previous confirmed diagnosis of B-cell acute lymphoblastic leukemia. Treatment with antibodies to CD19 may interfere with the ability to detect minimal residual disease.

Supportive Data

Sixty-seven patient samples were analyzed with 38 of these showing no measurable minimal residual disease (MRD). Three of these had levels greater than 20% acute lymphoblastic leukemia involvement. Eleven of these had 0.13% to 10.0% MRD involvement. The 15 with the lowest percent MRD involvement ranged from 0.003% to 0.08%. In addition, 25 normal bone marrows showed no MRD.

Method Description

Flow cytometric immunophenotyping (high sensitivity) of bone marrow is performed to evaluate the presence or absence of B lymphoblastic leukemia minimal residual disease using the following antibodies: BALLM Panel: CD10, CD19, CD20, CD22, CD24, CD34, CD38, CD45, CD58, and CD66c.(Cherian S, Miller V, McCullouch V, Dougherty K, Fromm JR, Wood BL. A novel flow cytometric assay for detection of residual disease in patients with B-lymphoblastic leukemia/lymphoma post anti-CD19 therapy. Cytometry B Clin Cytom. 2018;94(1):112-120)

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

Test Classification

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

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
BALLM B-ALL Monitoring, MRD Detection, V 102084-1

 

Result ID Test Result Name Result LOINC Value
CK173 BALLM Result No LOINC Needed
CK174 Final Diagnosis 22637-3
CK175 Special Studies 30954-2
CK176 Microscopic Description 22635-7

Forms

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