Test Catalog

Test Id : LLPB

Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Blood

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

Evaluating lymphocytoses of undetermined etiology

 

Identifying B- and T-cell lymphoproliferative disorders involving blood

 

Distinguishing acute lymphoblastic leukemia (ALL) from acute myeloid leukemia (AML) using whole blood specimens

 

Immunologic subtyping of ALL

 

Distinguishing reactive lymphocytes and lymphoid hyperplasia from malignant lymphoma using whole blood specimens

 

Distinguishing between malignant lymphoma and acute leukemia using whole blood specimens

 

Phenotypic subclassification of B- and T-cell chronic lymphoproliferative disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and hairy cell leukemia

 

Recognizing AML with minimal morphologic or cytochemical evidence of differentiation

 

Recognizing monoclonal plasma cells

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
FCINT Flow Cytometry Interp, 2-8 Markers No, (Bill Only) No
FCIMS Flow Cytometry Interp, 9-15 Markers No, (Bill Only) No
FCINS Flow Cytometry Interp,16 or greater No, (BIll Only) No

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial 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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

A screening triage panel is initially performed to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blast cells by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression and side scatter gating. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. This triage panel also determines if there is an increase in the number of T cells that aberrantly coexpress CD16, an immunophenotypic feature of T-cell granular lymphocytic leukemia.

 

If no abnormalities are detected by the initial panel, no further flow cytometric assessment will be performed unless otherwise indicated by specific features of the clinical presentation or prior laboratory results.

 

The triage screen panel, together with the provided clinical history and morphologic review, is used to determine what, if any, additional marker testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per the algorithm to fully characterize a disease state with a charge per unique antibody tested. Possible additional panels containing specific markers include, but are not limited to, the following: T-cell panel, B-cell panel, acute panel, myeloperoxidase/terminal deoxynucleotidyl transferase (MPO/TdT) panel, killer-cell immunoglobulin-like receptor panel, B-cell acute lymphoblastic leukemia (ALL) panel, plasma cell panel.

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.

No

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

Leukemia/Lymphoma Immunopheno, B

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

Acute Leukemia - Immunophenotyping, Flow Cytometry

Anti-kappa

Anti-lambda

B cell antigen

B cells, hematologic

B-cell ALL minimal residual disease (MRD) detection

B-cell clonality

Chronic Lymphocytic Leukemia, Immunophenotyping, Flow Cytometry

Flow Cytometry, Leukemia Immunophenotyping

Flow Cytometry, Lymphoma Immunophenotyping

GLL Panel - Leukemia Immunophenotyping

Granular Lymphocytic Leukemia

KIR Panel - Leukemia Immunophenotyping

Leukemia Immunophenotyping

Leukemia Lymphoma

LGL Panel - Leukemia Immunophenotyping

Lymphocytoflow

Lymphoma Immunophenotyping by Flow Cytometry

Mast Cell

NK Panel - Leukemia Immunophenotyping

Plasma cell clonality

T-cell clonality

T-cell receptor (TCR) flow cytometry

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

A screening triage panel is initially performed to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blast cells by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression and side scatter gating. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. This triage panel also determines if there is an increase in the number of T cells that aberrantly coexpress CD16, an immunophenotypic feature of T-cell granular lymphocytic leukemia.

 

If no abnormalities are detected by the initial panel, no further flow cytometric assessment will be performed unless otherwise indicated by specific features of the clinical presentation or prior laboratory results.

 

The triage screen panel, together with the provided clinical history and morphologic review, is used to determine what, if any, additional marker testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per the algorithm to fully characterize a disease state with a charge per unique antibody tested. Possible additional panels containing specific markers include, but are not limited to, the following: T-cell panel, B-cell panel, acute panel, myeloperoxidase/terminal deoxynucleotidyl transferase (MPO/TdT) panel, killer-cell immunoglobulin-like receptor panel, B-cell acute lymphoblastic leukemia (ALL) panel, plasma cell panel.

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

This test is appropriate for hematopoietic peripheral blood specimens only.

 

For bone marrow specimens, order LLBM / Leukemia/Lymphoma Immunophenotyping by Flow Cytometry, Bone Marrow.

 

For solid tissue specimens, order LLTS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Tissue.

 

For body fluid and cerebrospinal fluid specimens, order LLBF / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Body Fluid

Shipping Instructions

Specimen must arrive within 96 hours of collection.

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

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 labeled with two unique identifiers

Collection Instructions:

1. Send whole blood specimen in original tube. Do not aliquot.

2. Label specimen as blood.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

3 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
Whole blood Ambient 4 days

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

Evaluating lymphocytoses of undetermined etiology

 

Identifying B- and T-cell lymphoproliferative disorders involving blood

 

Distinguishing acute lymphoblastic leukemia (ALL) from acute myeloid leukemia (AML) using whole blood specimens

 

Immunologic subtyping of ALL

 

Distinguishing reactive lymphocytes and lymphoid hyperplasia from malignant lymphoma using whole blood specimens

 

Distinguishing between malignant lymphoma and acute leukemia using whole blood specimens

 

Phenotypic subclassification of B- and T-cell chronic lymphoproliferative disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and hairy cell leukemia

 

Recognizing AML with minimal morphologic or cytochemical evidence of differentiation

 

Recognizing monoclonal plasma cells

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

A screening triage panel is initially performed to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blast cells by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression and side scatter gating. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. This triage panel also determines if there is an increase in the number of T cells that aberrantly coexpress CD16, an immunophenotypic feature of T-cell granular lymphocytic leukemia.

 

If no abnormalities are detected by the initial panel, no further flow cytometric assessment will be performed unless otherwise indicated by specific features of the clinical presentation or prior laboratory results.

 

The triage screen panel, together with the provided clinical history and morphologic review, is used to determine what, if any, additional marker testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per the algorithm to fully characterize a disease state with a charge per unique antibody tested. Possible additional panels containing specific markers include, but are not limited to, the following: T-cell panel, B-cell panel, acute panel, myeloperoxidase/terminal deoxynucleotidyl transferase (MPO/TdT) panel, killer-cell immunoglobulin-like receptor panel, B-cell acute lymphoblastic leukemia (ALL) panel, plasma cell panel.

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

Diagnostic hematopathology has become an increasingly complex subspecialty, particularly with neoplastic disorders of blood and bone marrow. While morphologic assessment of blood smears, bone marrow smears, and tissue sections remains the cornerstone of lymphoma and leukemia diagnosis and classification, immunophenotyping is a very valuable and important complementary tool.

 

Immunophenotyping hematopoietic specimens can help resolve many differential diagnostic problems posed by the clinical or morphologic features.

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

Report will include a morphologic description, a summary of the procedure, the percent positivity of selected antigens, and an interpretive conclusion based on the correlation of the clinical history with the morphologic features and immunophenotypic results.

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

Specimens will be initially triaged to determine which, if any, of the immunophenotyping panels should be performed.

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

1. Hanson CA, Kurtin PJ, Katzman JA, et al. Immunophenotypic analysis of peripheral blood and bone marrow in the staging of B-cell malignant lymphoma. Blood. 1999;94(11):3889-3896

2. Hanson CA. Acute leukemias and myelodysplastic syndromes. In: McClatchey KD, ed. Clinical Laboratory Medicine. Williams and Wilkins; 1994:939-969

3. Morice WG, Leibson PJ, Tefferi A. Natural killer cells and the syndrome of chronic natural killer cell lymphocytosis. Leuk Lymphoma. 2001;41(3-4):277-284. doi: 10.3109/10428190109057982

4. Langerak, van Den Beemd, Wolvers-Tettero, et al. Molecular and flow cytometric analysis of the Vbeta repertoire for clonality assessment in mature TCRalphabeta T-cell proliferations. Blood. 2001;98(1):165-173. doi: 10.1182/blood.v98.1.165

5. Hoffman RA, Kung PC, Hansen QP, Goldstein G. Simple and rapid measurement of human T lymphocytes and their subclass in peripheral blood. Proc Natl Acad Sci USA. 1980;77(8):4914-4917. doi: 10.1073/pnas.77.8.4914

6. Jaffe ES, Cossman J. Immunodiagnosis of lymphoid and mononuclear phagocytic neoplasms. In: Rose NR, Friedman H, Fahey JD, eds. Manual of Clinical Immunology. 3rd ed. ASM Press; 1987:779-790

7. Morice WG, Kimlinger T, Katzmann JA, et al. Flow cytometric assessment of TCR-Vbeta expression in the evaluation of peripheral blood involvement by T-cell lymphoproliferative disorders: a comparison with conventional T-cell immunophenotyping and molecular genetic techniques. Am J Clin Pathol. 2004;121(3):373-383. doi: 10.1309/3A32-DTVM-H640-M2QA

8. Stelzer GT, Shultz KE, Loken MR. CD45 gating for routine flow cytometric analysis of bone marrow specimens. Ann NY Acad Sci. 1993;677:265-280. doi: 10.1111/j.1749-6632.1993.tb38783.x

9. Jevremovic D, Olteanu H. Flow cytometry applications in the diagnosis of T/NK-cell lymphoproliferative disorders. Cytometry B Clin Cytom. 2019;96(2):99-115. doi: 10.1002/cyto.b.21768

10. Shi M, Jevremovic D, Otteson GE, Timm MM, Olteanu H, Horna P. Single antibody detection of T-cell receptor alpha beta clonality by flow cytometry rapidly identifies mature T-Cell neoplasms and monotypic small CD8-positive subsets of uncertain significance. Cytometry B Clin Cytom. 2020;98(1):99-107

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

Flow cytometric immunophenotyping of peripheral blood is performed using the following antibodies:

Triage panel: CD3, CD10, CD16, CD19, CD34, CD45 and kappa and lambda light chains

 

Possible additional panels:

-B-cell panel: CD5, CD11c, CD19, CD20, CD22, CD23, CD38, CD45, CD103, CD200 and kappa and lambda light chains

-T-cell panel: CD2, CD3, CD4, CD5, CD7, CD8, CD45, and gamma/delta

-Killer-cell immunoglobulin-like receptor (KIR) panel: CD3, CD8, CD16, CD56, CD57, CD94, CD158a, CD158b, CD158e (p70), and NKG2a

-Acute panel: CD2, CD7, CD13, CD15, CD16, CD33, CD34, CD36, CD38, CD45, CD56, CD64, CD117, and HLA-DR

-B-cell ALL, minimal residual disease (MRD) panel: CD10, CD19, CD20, CD22, CD24, CD34, CD38, CD45, CD58, CD66c.

-Myeloperoxidase/terminal deoxynucleotidyl transferase (MPO/TdT) panel: cytoplasmic CD3, CD13, cytoplasmic CD22, CD34, CD45, cytoplasmic CD79a, nuclear TdT, and cytoplasmic MPO

-Plasma cell panel: CD19, CD38, CD45, CD138, and cytoplasmic kappa and lambda light chains

(Keren P, McCoy Jr JP, Carey J. Flow Cytometry in Clinical Diagnosis. 4th ed. ASCP Press; 2007; Betters DM: Use of flow cytometry in clinical practice. J Adv Pract Oncol. 2015;6[5]:435-440. doi: 10.6004/jadpro.2015.6.5.4)

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.

Monday through Friday, Sunday

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

Jacksonville

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.

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  • 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 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 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 x 1

88185-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)

88187-Flow Cytometry Interpretation, 2 to 8 Markers (if appropriate)

88188-Flow Cytometry Interpretation, 9 to 15 Markers (if appropriate)

88189-Flow Cytometry Interpretation, 16 or More Markers (if appropriate)

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
LLPB Leukemia/Lymphoma Immunopheno, B In Process
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.
JF001 Interpretation 69052-9

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 | PHP Pdf | CMS 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