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Test ID BALLM B-Cell Lymphoblastic Leukemia Monitoring, Minimal Residual Disease Detection, Flow Cytometry, Varies


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 72 hours 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

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

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.

Clinical Reference

1. Bader P, Kreyenberg H, Henze GHR, et al: Prognostic value of minimal residual disease quantification before allogeneic stem-cell transplantation in relapsed childhood acute lymphoblastic leukemia: the ALL-REZ BFM Study Group. J Clin Oncol. 2009 Jan 20;27:377-384

2. Borowitz MJ, Devidas M, Hunger SP, et al: Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood. 2008 Jun 15;111(12):5477-5485

3. Borowitz MJ, Pullen DJ, Winick N, Martin PL, Bowman WP, Camitta B: Comparison of diagnostic and relapse flow cytometry phenotypes in childhood acute lymphoblastic leukemia: implications for residual disease detection: a report from the children's oncology group. Cytometry B Clin Cytom. 2005 Nov;68(1):18-24

4. Campana D: Role of minimal residual disease monitoring in adult and pediatric acute lymphoblastic leukemia. Hematol Oncol Clin North Am. 2009 Oct;23(5):1083-1098

5. Chen W, Karadikar NJ, McKenna RW, Kroft SH: Stability of leukemia-associated immunophenotypes in precursor B-lymphoblastic leukemia/lymphoma: a single institution experience. Am J Clin Pathol. 2007 Jan;127(1):39-46

6. Coustan-Smith E, Ribeiro RC, Stow P, et al: A simplified flow cytometric assay identifies children with acute lymphoblastic leukemia who have a superior clinical outcome. Blood. 2006 Jul 1;108(1):97-102

7. Coustan-Smith E, Sancho J, Behm FG, et al: Prognostic importance of measuring early clearance of leukemic cells by flow cytometry in childhood acute lymphoblastic leukemia. Blood. 2002 Jul 1;100(1):52-58

8. Guillaume N, Penther D, Vaida I, et al: CD66c expression in B-cell lymphoblastic leukemia: strength and weakness. Int J Lab Hematol. 2011 Feb;33(1):92-96

9. Stow P, Key L, Chen X, et al: Clinical significance of low levels of minimal residual disease at the end of remission induction therapy in childhood acute lymphoblastic leukemia. Blood. 2010 Jun 10;115(23):4657-4663

10. Wood BL: Principals of minimal residual disease detection for hematopoietic neoplasms by flow cytometry. Cytometry B Clin Cytom. 2016 Jan;90(1):47-53

Day(s) Performed

Monday through Friday

Report Available

1 to 4 days

Test Classification

This test was developed, and its performance characteristics 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

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 In Process

 

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