Test Catalog

Test Id : LLTOF

Leukemia and Lymphoma Phenotyping, Technical Only, Varies

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 and bone marrow

 

Distinguishing acute lymphoblastic leukemia from acute myeloid leukemia (AML)

 

Immunologic subtyping of acute leukemias

 

Distinguishing reactive lymphocytes and lymphoid hyperplasia from malignant lymphoma

 

Distinguishing between malignant lymphoma and acute leukemia

 

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.

Note: This test is only available to clients who have MayoAccess or MayoLink.

 

The client is responsible for the interpretation and billing of the professional component; Mayo Clinic will bill the technical component only.

 

The testing process begins with a screening panel. The screening panel will be charged based on the number of markers tested (FIRST for first marker, ADD1 for each additional marker). In addition, reflex testing may occur to fully characterize a disease state or clarify any abnormalities from the screening test. Reflex tests will be performed at an additional charge for each marker tested (ADD1 if applicable).

 

The triage panel is initially performed on peripheral blood, bone marrow, and fluid samples to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blasts by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression with 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 (NK) 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.

 

The tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, increased numbers of blasts, and plasma cells by CD45 expression along with side scatter gating. The panel can also evaluate T cells with CD3, CD5, and CD7. Additionally, viability is assessed on all tissue specimens using 7-AAD exclusion.

 

These panels, together with the provided clinical history and morphologic review, are used to determine what, if any, further testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per algorithm to fully characterize a disease state with a charge per unique antibody tested.

 

Cases requiring the granular lymphocytic leukemia flow panel will have an interpretation added and performed by a Mayo Clinic pathologist.

 

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 following algorithms are available in Special Instructions:

-Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm

-Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up

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

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

Leukemia/Lymphoma; Tech Only Flow

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

Tech Flow

Technical Only Flow

Tech Only Immunophenotyping

Technical Only Immunophenotyping

Virtual Flow

Leukemia Lymphoma

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

Note: This test is only available to clients who have MayoAccess or MayoLink.

 

The client is responsible for the interpretation and billing of the professional component; Mayo Clinic will bill the technical component only.

 

The testing process begins with a screening panel. The screening panel will be charged based on the number of markers tested (FIRST for first marker, ADD1 for each additional marker). In addition, reflex testing may occur to fully characterize a disease state or clarify any abnormalities from the screening test. Reflex tests will be performed at an additional charge for each marker tested (ADD1 if applicable).

 

The triage panel is initially performed on peripheral blood, bone marrow, and fluid samples to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blasts by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression with 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 (NK) 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.

 

The tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, increased numbers of blasts, and plasma cells by CD45 expression along with side scatter gating. The panel can also evaluate T cells with CD3, CD5, and CD7. Additionally, viability is assessed on all tissue specimens using 7-AAD exclusion.

 

These panels, together with the provided clinical history and morphologic review, are used to determine what, if any, further testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per algorithm to fully characterize a disease state with a charge per unique antibody tested.

 

Cases requiring the granular lymphocytic leukemia flow panel will have an interpretation added and performed by a Mayo Clinic pathologist.

 

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 following algorithms are available in Special Instructions:

-Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm

-Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

For bone marrow specimens being evaluated for possible involvement by a myelodysplastic syndrome (MDS) or a myelodysplastic/myeloproliferative neoplasm (MDS/MPN) including chronic myelomonocytic leukemia (CMML), order MYEFL / Myelodysplastic Syndrome by Flow Cytometry, Bone Marrow.

 

Bronchoalveolar lavage specimens submitted for evaluation for leukemia or lymphoma are appropriate to send for this test.

 

This test is not appropriate for and cannot support diagnosis of sarcoidosis, hypersensitivity pneumonitis, interstitial lung diseases, or differentiating between pulmonary tuberculosis and sarcoidosis (requests for CD4/CD8 ratios); specimens sent for these purposes will be rejected.

Additional Testing Requirements

For bone marrow testing, if cytogenetic tests are desired along with this test request, an additional specimen should be submitted. It is important that the specimen be obtained, processed, and transported according to instructions for the other test.

Shipping Instructions

Specimen must arrive within 48 hours of collection for spinal fluid, 72 hours for serous fluids, and 96 hours for peripheral blood, bone marrow, and tissues.

Necessary Information

1. The following information is required:

a. Pertinent clinical history including reason for testing or clinical indication

b. Clinical or morphologic suspicion

c. Specimen source

d. Date and time of collection

e. For spinal fluid specimens: spinal fluid cell and differential counts are required.

f. For tissue specimens: tissue type and location are required.

2. A pathology/diagnostic report including the client surgical pathology case number, a brief history, reason for referral or clinical suspicion are required before the specimen will be processed.

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: Green top (sodium heparin) or lavender top (EDTA)

Specimen Volume: 10 mL

Slides: Include 5 to 10 unstained blood smears, if possible.

Collection Instructions:

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

2. Label specimen as blood.

Specimen Stability Information: Ambient <96 hours/Refrigerated < or =96 hours

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Green top (sodium heparin) or lavender top (EDTA)

Specimen Volume: 1-5 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 as bone marrow.

Specimen Stability Information: Ambient <96 hours/Refrigerated < or =96 hours

 

Specimen Type: Fluid

Sources: Serous effusions, pleural, pericardial, or abdominal (peritoneal fluid)

Container/Tube: Body fluid container

Specimen Volume: 20 mL

Collection Instructions:

1. If possible, fluids other than spinal fluid should be anticoagulated with heparin (1 U/mL of fluid).

2. The volume of fluid necessary to phenotype the lymphocytes or blasts in serous effusions depends upon the cell count in the specimen. Usually 20 mL of pleural or peritoneal fluid is sufficient. Smaller volumes can be used if there is a high cell count.

3. Label specimen with fluid type.

Specimen Stability Information: Refrigerated <72 hours/Ambient < or =72 hours

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 1-1.5 mL

Collection Instructions:

1. An original cytospin preparation (preferably unstained) must be included with the spinal fluid specimen so correlative morphologic evaluation can occur.

2. The volume of fluid necessary to phenotype the lymphocytes or blasts in spinal fluid depends upon the cell count in the specimen. A cell count should be determined and submitted with the specimen. Usually 1 to 1.5 mL of spinal fluid is sufficient. Smaller volumes can be used if there is a high cell count. If cell count is <10 cells/mcL, a larger volume of spinal fluid may be required. When cell counts drop below 5 cells/mcL, the immunophenotypic analysis may not be successful.

3. Label specimen as spinal fluid.

Specimen Stability Information: Refrigerated <48 hours/Ambient < or =48 hours

 

Specimen Type: Tissue

Supplies: Hank's Solution (T132)

Container/Tube: Sterile container with 15 mL of tissue culture medium (eg, Hank's balanced salt solution, RPMI, or equivalent)

Specimen Volume: 5 mm(3) or larger biopsy

Specimen Stability Information: Ambient <96 hours/Refrigerated < or =96 hours

Collection Instructions:

1. Send intact specimen (do not mince).

2. Specimen cannot be fixed.

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

Forms

1. Hematopathology Patient Information (T676) in Special Instructions

2. 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

Blood: 3 mL

Bone Marrow, Spinal Fluid: 1 mL

Fluid from Serous Effusions: 5 mL

Tissue: 1 mm(3) or larger biopsy

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

Gross hemolysis Reject
Fixed, paraffin-embedded, or minced tissue 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 Varies (preferred)

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 and bone marrow

 

Distinguishing acute lymphoblastic leukemia from acute myeloid leukemia (AML)

 

Immunologic subtyping of acute leukemias

 

Distinguishing reactive lymphocytes and lymphoid hyperplasia from malignant lymphoma

 

Distinguishing between malignant lymphoma and acute leukemia

 

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.

Note: This test is only available to clients who have MayoAccess or MayoLink.

 

The client is responsible for the interpretation and billing of the professional component; Mayo Clinic will bill the technical component only.

 

The testing process begins with a screening panel. The screening panel will be charged based on the number of markers tested (FIRST for first marker, ADD1 for each additional marker). In addition, reflex testing may occur to fully characterize a disease state or clarify any abnormalities from the screening test. Reflex tests will be performed at an additional charge for each marker tested (ADD1 if applicable).

 

The triage panel is initially performed on peripheral blood, bone marrow, and fluid samples to evaluate for monotypic B cells by kappa and lambda light chain expression, increased numbers of blasts by CD34 and CD45 expression along with side scatter gating, and increased plasma cells by CD45 expression with 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 (NK) 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.

 

The tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, increased numbers of blasts, and plasma cells by CD45 expression along with side scatter gating. The panel can also evaluate T cells with CD3, CD5, and CD7. Additionally, viability is assessed on all tissue specimens using 7-AAD exclusion.

 

These panels, together with the provided clinical history and morphologic review, are used to determine what, if any, further testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per algorithm to fully characterize a disease state with a charge per unique antibody tested.

 

Cases requiring the granular lymphocytic leukemia flow panel will have an interpretation added and performed by a Mayo Clinic pathologist.

 

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 following algorithms are available in Special Instructions:

-Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm

-Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up

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. This test is appropriate for hematopoietic specimens only.

 

This is a technical only test and does not include interpretation unless reflex testing is performed. At any point, clients may request to have a Mayo Clinic hematopathologist provide an interpretation at an additional charge.

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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

Report will include a summary of the procedure.

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

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

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

1. Jevremovic D, Dronca RS, Morice WG, et al: CD5+ B-cell lymphoproliferative disorders: Beyond chronic lymphocytic leukemia and mantle cell lymphoma. Leuk Res. 2010;34(9):1235-1238

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

3. 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

4. Rosado FG, Morice WG, He R, et al: Immunophenotypic features by multiparameter flow cytometry can help distinguish low grade B-cell lymphomas with plasmacytic differentiation from plasma cell proliferative disorders with an unrelated clonal B-cell process. Br J Haematol. 2015 May;169(3):368-376

5. Shi M, Ternus JA, Ketterling RP, et al: Immunophenotypic and laboratory features of t(11;14)(q13;q32)-positive plasma cell neoplasms. Leuk Lymphoma. 2018;59(8):1913-1919

6. Morice WG, Kimlinger T, Katzmann JA, et al: Flow cytometric assessment of TCR-V-beta 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

7. 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 Jan;98(1):99-107

8. 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

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

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

Flow cytometric immunophenotyping of peripheral blood, bone marrow, and body fluids is performed using the following antibodies:

 

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

 

Flow cytometric immunophenotyping of tissues is performed using the following antibodies:

Tissue Panel: CD3, CD5, CD7, CD10, CD19, CD20, CD23, CD45, 7-AAD, 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, TRBC1, 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, and CD66c

-Myeloperoxidase (MPO)/terminal deoxynucleotidyl transferase (TdT) (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

-Mast Cell Panel: CD2, CD25, CD69, CD117.(Keren P, McCoy JP, Carey J, eds. Flow Cytometry in Clinical Diagnosis. 4th ed. ASCP Press; 2007; Betters DM: Use of flow cytometry in clinical practice. J Adv Pract Oncol. 2015 Sep-Oct;6[5]:435–440)

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

Supplemental

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 Saturday

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

Remaining blood/bone marrow: 14 days; Remaining tissue/fluid: 7 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 Regional Manager. 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

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

Additional CPTs may be added if consultative help is needed with the case, or algorithm dictates Mayo consultant involvement.

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
LLTOF Leukemia/Lymphoma; Tech Only Flow 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.
CK072 Final Diagnosis 22637-3
CK073 Microscopic Description 22635-7
CK074 Special Studies 30954-2
CK071 Flow Cytometry 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 | 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