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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 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

 

This test is not intended for detection of minimal residual disease below 5% blasts.

Additional Tests

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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
FCIMS Flow Cytometry Interp, 9-15 Markers No, (Bill Only) No
FCINS Flow Cytometry Interp,16 or greater No, (Bill Only) No
FCINT Flow Cytometry Interp, 2-8 Markers No, (Bill Only) No
AMLMF AML, Specified FISH Yes 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. Central time) 2 days after the collection date. For testing to be canceled, the client must call 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, call 800-533-1710.

 

The testing process begins with a screening panel. The 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).

 

In addition to reflexing flow cytometric panels, AMLF / Acute Myeloid Leukemia (AML), FISH, Varies testing for PML::RARA translocation t(15;17),may be added by the Mayo Clinic pathologist to exclude acute promyelocytic leukemia if there is morphologic suspicion and/or blasts and promyelocytes are CD34 and HLA-DR-negative.

 

The triage panel is initially performed on peripheral blood, bone marrow, and fluid samples to evaluate for monotypic B cells by kappa and lambda immunoglobulin 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 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 triage panel is initially performed on tissue specimens to evaluate for monotypic B cells by kappa and lambda immunoglobulin light chain expression, CD5,CD10,CD19,CD20, and CD23. Increased numbers of blasts and plasma cells are identified 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 (7-amino actinomycin d) exclusion.

 

This testing, together with the provided clinical history and morphologic review is used to determine what, if any, additional 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, fluorescence in situ hybridization (FISH), molecular testing or cytochemical stains may be recommended by the Mayo Clinic pathologist to facilitate diagnosis. They will contact the referring provider or pathologist to confirm the addition of these tests.

 

The following algorithms are available:

-Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm

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

Method Name

Immunophenotyping

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Ordering Guidance


For B-cell acute lymphoblastic leukemia minimal residual disease testing in either blood or bone marrow, order BALLM / B-Cell Lymphoblastic Leukemia Monitoring, Minimal Residual Disease Detection, Flow Cytometry, Varies. 

 

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.

 

This test is not intended for products of conception (POC) specimens. For POC specimens see CMAPC / Chromosomal Microarray, Autopsy, Products of Conception, or Stillbirth.



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 4 days of collection.



Necessary Information


The following information is required:

1. Pertinent clinical history, including reason for testing or clinical indication/morphologic suspicion

2. Specimen source

3. For tissue specimens:

-Tissue type

-Location

-Pathology/diagnostic report, including the client surgical pathology case number



Specimen Required


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

 

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) or Green top (sodium heparin)

Specimen Volume: 10 mL

Slides: If possible, include 5- to 10-unstained blood smears, must be labeled with two unique identifiers.

Collection Instructions:

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

2. Label specimen as blood.

Specimen Stability Information: Ambient ≤4 days/Refrigerated ≤4 days 

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA) or green top (sodium heparin)

Specimen Volume: 1 to 5 mL

Slides: If possible, include 5- to 10-unstained bone marrow aspirate smears, which must be labeled with two 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.

Specimen Stability Information: Ambient ≤4 days/Refrigerated ≤4 days

 

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 should be anticoagulated with heparin (1 U/mL of fluid).

2. Label specimen with fluid type.

Specimen Stability Information: Refrigerated/Ambient ≤4 days

Additional Information: 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.

 

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

Collection Instructions:

1. Send intact specimen (do not mince)

2. Specimen cannot be fixed.

Specimen Stability Information: Ambient ≤4 days/Refrigerated ≤4 days


Specimen Minimum Volume

Blood: 3 mL
Bone Marrow: 0.5 mL
Fluid: 5 mL
Tissue: 1 mm(3) or larger biopsy

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies

Reject Due To

Gross hemolysis Reject
Fixed, paraffin-embedded, or minced tissue Reject

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Saturday 

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 No LOINC Needed

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 US Food and Drug Administration.

Report Available

2 to 4 days

NY State Approved

Yes

Forms

1. Hematopathology Patient Information (T676)

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