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Test Code HLLFH Hematologic Disorders, Leukemia/Lymphoma; Flow Hold Varies

Reporting Name

Heme Leukemia/Lymphoma; Flow Hold V

Useful For

Evaluating lymphocytoses of undetermined etiology

 

Identifying B- and T-cell lymphoproliferative disorders involving blood and bone marrow

 

Distinguishing acute lymphoblastic leukemia (ALL) from acute myeloid leukemia (AML)

 

Immunologic subtyping of ALL

 

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

Test ID Reporting Name Available Separately Always Performed
FCINT Flow Cytometry Interp, 2-8 Markers No No
FCIMS Flow Cytometry Interp, 9-15 Markers No No
FCINS Flow Cytometry Interp,16 or greater No No

Testing Algorithm

This test is designed to delay the start of leukemia/lymphoma immunophenotyping until the preliminary assessment is completed. Specimens are held in the laboratory until noon (12 p.m. CST) 2 days after the collection date. For testing to be cancelled, the client must call Mayo Medical Laboratories at 800-533-1710. The testing process will be initiated and fully charged if no notification is received within this time period. To expedite the beginning of testing, please call Mayo Medical Laboratories at 800-533-1710.

 

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). The interpretation will be based on markers tested in increments of 2 to 8, 9 to 15, or 16 and greater. 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 (FIRST if applicable, 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 and 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. 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.

 

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.

 

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.

 

In addition to reflexing flow cytometric panels, FISH or molecular testing may be recommended by the Mayo pathologist to facilitate diagnosis. They will contact the referring physician or pathologist to confirm the addition of these tests.

These include:

Cytogenetic FISH studies

-CCND1/IGH translocation t(11;14), to exclude mantle cell lymphoma in cases of CD5+CD23- B-cell lymphoproliferative disorder.

-PML-RARA translocation t(15;17), to exclude acute promyelocytic leukemia if there is morphologic suspicion and/or blasts and promyelocytes are CD34 and HLA-DR-negative.

-TCL-1 break-apart at 14q32, to exclude T-cell prolymphocytic leukemia in cases with CD4-positive T-cell lymphoproliferative disorder (phenotypic aberrancy or very tight CD4+ population with high CD4:CD8 ratio).

-MYC break-apart at 8q24, with or without IGH-BCL2 t(14;18) and BCL6 break-apart at 3q27, for suspected high grade B-cell lymphomas, based on morphologic assessment and immunophenotype (usually CD10-positive).

 

Molecular genetic studies:

-T-cell receptor gene rearrangement to examine clonality of T cells in cases showing phenotypically aberrant T-cell population.

 

Cytochemical stains:

Confirmatory cytochemical stains are performed as needed.

 

The following algorithms are available in Special Instructions:

-Malignant Lymphoma, Guideline for Bone Marrow Staging Studies

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

Performing Laboratory

Mayo Medical Laboratories in Rochester

Specimen Type

Varies


Advisory Information


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) should be ordered as 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 also desired when drawing this test, 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


Specimen must arrive within 96 hours for peripheral blood, bone marrow, and tissue, or 72 hours for fluids.



Necessary Information


1. The following information is required:

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

b. Clinical or morphologic suspicion

c. Specimen source

d. Date and time of collection

e. 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


Due to specimen stability, spinal fluid is not appropriate for this test.

 

Submit only 1 of the following specimens:

 

Specimen Type: Blood

Container/Tube:

Preferred: Yellow top (ACD solution B)

Acceptable: ACD (solution A), heparin, EDTA

Specimen Volume: 10 mL

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

Specimen Stability Information: Ambient/Refrigerated <96 hours

Collection Instructions:

1. Do not transfer blood to other containers.

2. Label specimen as blood.

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution B)

Acceptable: ACD (solution A), heparin, EDTA

Specimen Volume: 1-5 mL

Slides: Include 5- to 10-unstained bone marrow aspirate smears, if possible.

Specimen Stability Information: Ambient/Refrigerated <96 hours

Collection Instructions:

1. Submission of bilateral specimens is not required.

2. Label specimen as bone marrow.

 

Specimen Type: Fluid

Sources: Serous effusions

Container/Tube: Body fluid container

Specimen Volume: 20 mL

Specimen Stability Information: Refrigerated/Ambient <72 hours

Collection Instructions:

1. If possible, the 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.

 

Supplies:Hank's Solution (T132)

Specimen Type: Tissue

Container/Tube: Sterile container with 15 mL of tissue culture medium (eg. Hank's balanced salt solution [T132], RPMI, or equivalent)

Specimen Volume: 5 mm(3) or larger biopsy

Specimen Stability Information: Ambient/Refrigerated <96 hours

Collection Instructions:

1. Send intact specimen (do not mince).

2. Specimen cannot be fixed.


Specimen Minimum Volume

Blood: 3 mL; Bone Marrow: 1 mL; Fluid: 5 mL; Tissue: 1 mm(3) or larger biopsy

Specimen Stability Information

Specimen Type Temperature Time
Varies Varies

Reference Values

When performed, 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.

Day(s) and Time(s) Performed

Specimens are processed and reported Monday through Saturday

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.

CPT Code Information

88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker

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 Code Information

Test ID Test Order Name Order LOINC Value
HLLFH Heme Leukemia/Lymphoma; Flow Hold V In Process

 

Result ID Test Result Name Result LOINC Value
CK075 Final Diagnosis 34574-4
CK076 Special Studies 30954-2
CK077 Microscopic Description 22635-7
CK078 Flow Cytometry Testing In Process

Analytic Time

2 days

NY State Approved

Yes

Method Name

Immunophenotyping

Additional Tests

Test ID Reporting Name Available Separately Always Performed
FIRST Flow Cytometry, Cell Surface, First No Yes
ADD1 Flow Cytometry, Cell Surface, Addl No Yes

Forms

1. Hematopathology Patient Information (T676) in Special Instructions

2. 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)