Test Catalog

Test Id : BALLM

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

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Immunophenotyping

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

B-ALL Monitoring, MRD Detection, V

Aliases
Lists additional common names for a test, as an aid in searching

Acute Minimal Residual Disease

ALL-MRD

B-ALL MRD

B-cell ALL MRD

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

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 3 days of collection.

Necessary Information

A copy of the diagnostic flow cytometry report is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Blood: 2 mL

Bone Marrow: 1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Ambient 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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;27(3):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;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;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;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;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;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;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;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;115(23):4657-4663

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

Method Description
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Preanalytical processing: Monday through Saturday

Results reported: Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

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® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports