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Test Code ALLM B-ALL Monitoring, MRD Detection, Bone Marrow

Useful For

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

Additional Tests

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

Testing Algorithm

When this test is ordered, flow cytometry interpretation, 2 to 8 markers will always be performed at an additional charge.

Reporting Name

B-ALL Monitoring, MRD Detection, BM

Specimen Type

Bone Marrow


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.



Necessary Information


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.



Specimen Required


Container/Tube:

Preferred: Yellow top (ACD)
Acceptable: EDTA, heparin
Specimen Volume: 3 mL

Slides: Include 5- to 10-unstained bone marrow aspirate smears, if possible.
Collection Instructions:
1. Submission of bilateral specimens is not required.
2. Label specimen appropriately (bone marrow).


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Bone Marrow Ambient

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

Clinical Information

B-cell lymphoblastic leukemia/lymphoma (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 also occurs 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 0.01% sensitivity) is an important prognostic indicator in these patients.

 

This test is used to establish an antigen footprint of tumor cells at diagnosis to monitor minimal residual disease in these patients after treatments and/or transplants.

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 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 lymphoblastic leukemia. Treatment with antibodies to CD19 may interfere with the ability to detect minimal residual disease (MRD).

Supportive Data

Thirty-three patient samples were analyzed with 14 of these showing no measurable minimal residual disease (MRD). Nine of these had levels greater than 50% ALL involvement. Six of these had 2.19% to 24.39% MRD involvement. The 4 with the lowest percent MRD involvement were 0.2%, 0.05%, 0.02%, and 0.01% (assay sensitivity).

Clinical Reference

1. Bader P, Kreyenberg H, Henze GH, et al: ALL-REZ BFM Study Group. 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;27:377-384

2. Borowitz MJ, Devidas M, Hunger SP, et al; Children's Oncology Group. 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;111:5477-5485

3. Borowitz MJ, Pullen DJ, Winick N, et al: 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;68:18-24

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

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

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;108:97-102

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;100:52-58

8. Coustan-Smith E, Sancho J, Hancock ML, et al: Clinical importance of minimal residual disease in childhood acute lymphoblastic leukemia. Blood 2000;96:2691-2696

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

10. Lucio P, Gaipa G, van Lochem EG, et al: BIOMED-I concerted action report: flow cytometric immunophenotyping of precursor B-ALL with standardized triple-stainings. BIOMED-1 Concerted Action Investigation of Minimal Residual Disease in Acute Leukemia: International Standardization and Clinical Evaluation. Leukemia 2001;15:1185-1192

11. McKenna RW, Washington LT, Aquino DB, et al: Immunophenotypic analysis of hematogones (B-lymphocyte precursors) in 662 consecutive bone marrow specimens by 4-color flow cytometry. Blood 2001;98:2498-2507

12. 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;115:4657-4663

13. Weir EG, Cowan K, LeBeau P, Borowitz MJ: A limited antibody panel can distinguish B-precursor acute lymphoblastic leukemia from normal B precursors with four color flow cytometry: implications for residual disease detection. Leukemia 1999;13:558-567

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:

ALLM Panel: CD9, CD10, CD19, CD20, CD34, CD38, CD45, and CD66c.(Flow Cytometry in Clinical Diagnosis. Fourth edition. Edited by P Keren, JP McCoy Jr, J Carey. ASCP Press, Chicago, IL, 2007)

Day(s) and Time(s) Performed

Specimens are processed and reported Monday through Saturday

Analytic Time

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

CPT Code Information

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ALLM B-ALL Monitoring, MRD Detection, BM In Process

 

Result ID Test Result Name Result LOINC Value
CK085 ALLM Result In Process
CK088 Final Diagnosis 22637-3
CK089 Special Studies 22635-7
CK090 Microscopic Description 22635-7

Method Name

Immunophenotyping

Test Classification

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 U.S. Food and Drug Administration.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
FCINT Flow Cytometry Interp, 2-8 Markers No, (Bill Only) No

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request Form (T726) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/hematopathology-request-form.pdf)