Test Catalog

Test Id : LLPT

Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Tissue

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

Evaluation of tissues for potential involvement by:

-Chronic lymphoproliferative disorders

-Malignant lymphomas

-Acute lymphoblastic leukemia

-Acute myelogenous leukemia

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.

When this test is ordered, a screening panel and a professional interpretation will always be charged. The screening panel will be charged based on number of makers tested (FIRST for first marker, ADD1 for each additional marker). The interpretation will be set based on markers tested in increments of 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 tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, and 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.

 

This panel, together with the provided clinical history and morphologic review, is 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.

 

In addition to reflexing flow cytometric panels, fluorescence in situ hybridization (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.

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 Phenotype, Tissue

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

Flow Cytometry, Tissue

Leukemia Immunophenotyping, Tissue Panel

Lymphoma Immunophenotyping by Flow Cytometry

Lymphoma Immunophenotyping, Tissue

Tissue Panel, Leukemia Immunophenotyping

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

When this test is ordered, a screening panel and a professional interpretation will always be charged. The screening panel will be charged based on number of makers tested (FIRST for first marker, ADD1 for each additional marker). The interpretation will be set based on markers tested in increments of 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 tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, and 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.

 

This panel, together with the provided clinical history and morphologic review, is 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.

 

In addition to reflexing flow cytometric panels, fluorescence in situ hybridization (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.

Specimen Type
Describes the specimen type validated for testing

Tissue

Shipping Instructions

Specimen must arrive within 96 hours of collection.

Necessary Information

1. Date, time of collection, tissue type, and location are required.

2. A pathology/diagnostic report including the client surgical pathology case number, a brief history, reason for testing 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

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. Collect fine-needle aspirate.

2. Send intact specimen (do not mince).

3. 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

1 mm(3)

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

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
Tissue Refrigerated (preferred)
Ambient

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

Evaluation of tissues for potential involvement by:

-Chronic lymphoproliferative disorders

-Malignant lymphomas

-Acute lymphoblastic leukemia

-Acute myelogenous leukemia

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

When this test is ordered, a screening panel and a professional interpretation will always be charged. The screening panel will be charged based on number of makers tested (FIRST for first marker, ADD1 for each additional marker). The interpretation will be set based on markers tested in increments of 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 tissue panel is initially performed to evaluate for monotypic B-cells by kappa and lambda light chain expression, and 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.

 

This panel, together with the provided clinical history and morphologic review, is 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.

 

In addition to reflexing flow cytometric panels, fluorescence in situ hybridization (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.

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

Cellular immunophenotyping, characterizing cells by using antibodies directed against cell surface markers, is generally regarded as a fundamental element in establishing a diagnosis of tissue involvement by hematolymphoid malignancies, when used in conjunction with morphologic assessment. It is also an essential component in subclassification of hematolymphoid malignancies when present.

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.

Interpretation
Provides information to assist in interpretation of the test results

Normal tissues typically contain a mixture of B cells with polytypic surface immunoglobulin light chain expression and T cells with unremarkable expression of the T cell-associated antigens CD3, CD5, and CD7. Typically, no appreciable blast population is present by CD45 and side scatter analysis.

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

It is well recognized that a negative flow cytometry result does not exclude tissue involvement by hematolymphoid malignancy. This may be attributable to sampling bias, although some malignancies, such as Hodgkin lymphoma, are not detected by this technique.

 

Viability will be assessed in all tissue specimens. Cases in which the viability is low (<50%) are prone to false-negative results and, therefore, must be interpreted with caution. In cases with viability less than 30%, testing will be attempted but may not be interpretable. Fine-needle aspiration and small biopsy specimens have a higher frequency of low cell counts and poor viability, which may be uninterpretable.

 

Even when abnormal, in most instances the results of flow cytometry are insufficient for complete subclassification of a hematolymphoid malignancy. Precise subclassification requires correlation with the histopathologic features in paraffin-embedded materials and also, in some instances, the results of cytogenetic analyses.

 

The tissue used for flow cytometry cannot be subsequently submitted for histopathologic evaluation. For this reason, this technique should be avoided in small biopsy specimens.

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

1. Morice WG, Hodnefield JM, Kurtin PJ, Hanson CA: An unusual case of leukemic mantle cell lymphoma with a blastoid component showing loss of CD5 and aberrant expression of CD10. Am J Clin Pathol. 2004 July;122(1):122-127

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

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

4. Witzig TE, Banks PM, Stenson MJ, et al: Rapid immunotyping of B-cell non-Hodgkin's lymphomas by flow cytometry. A comparison with the standard frozen-section method. Am J Clin Pathol. 1990 Sep;94(3):280-286

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

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

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

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 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

KIR Panel: CD3, CD8, CD16, CD56, CD57, CD94, CD158a, CD158b, CD158e (p70) and NKG2a

Acute Panel: CD2, CD3, CD5, CD7, CD13, CD15, CD19, CD20, CD33, CD34, CD45, CD56, 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

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 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 tissue 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 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)

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