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Test Id : SZDIA

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Sezary Diagnostic Flow Cytometry, Blood

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Overview

Test Catalog

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

Identifying immunophenotypically aberrant T-cell populations with restricted expression of T-cell receptor beta-chain constant in peripheral blood, to roughly assess the circulating tumor burden in cutaneous T-cell lymphomas

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
FCIMS Flow Cytometry Interp, 9-15 Markers No No
FCINS Flow Cytometry Interp,16 or greater No 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 Yes
ADD1 Flow Cytometry, Cell Surface, Addl No Yes

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

This Sezary panel is ordered for patients with a clinical suspicion of Sezary syndrome or cutaneous T-cell lymphoma with peripheral blood involvement without a previously confirmed diagnosis. A Triage panel and Sezary panel will always be performed. This test is not indicated for monitoring peripheral blood involvement in patients with a diagnosis of Sezary syndrome or mycosis fungoides. For monitoring purposes, order SZMON / Sezary Monitoring Flow Cytometry, Blood.

 

The panel is charged based on 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 testing process begins with a triage panel to evaluate for and exclude monotypic B cells or increased numbers of blasts. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. Additional reflex testing may occur to fully characterize a disease state per algorithmic approach or clarify any abnormalities from the screening test at an additional charge for each marker tested (ADD1 if applicable). For a comprehensive list of potential additional panels, refer to LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies.

 

The Sezary panel will further evaluate the T cells for expression of CD2, CD4, CD5, CD7, CD8, CD26, and TRBC1.

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

Sezary Diagnostic Flow Cytometry, B

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

Sezary

Leukemic CTCL

Mycosis fungoides

Circulating T-cell lymphoma

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

This Sezary panel is ordered for patients with a clinical suspicion of Sezary syndrome or cutaneous T-cell lymphoma with peripheral blood involvement without a previously confirmed diagnosis. A Triage panel and Sezary panel will always be performed. This test is not indicated for monitoring peripheral blood involvement in patients with a diagnosis of Sezary syndrome or mycosis fungoides. For monitoring purposes, order SZMON / Sezary Monitoring Flow Cytometry, Blood.

 

The panel is charged based on 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 testing process begins with a triage panel to evaluate for and exclude monotypic B cells or increased numbers of blasts. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. Additional reflex testing may occur to fully characterize a disease state per algorithmic approach or clarify any abnormalities from the screening test at an additional charge for each marker tested (ADD1 if applicable). For a comprehensive list of potential additional panels, refer to LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies.

 

The Sezary panel will further evaluate the T cells for expression of CD2, CD4, CD5, CD7, CD8, CD26, and TRBC1.

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

This test is not indicated for monitoring patients with a diagnosis of Sezary syndrome. For monitoring purposes, order SZMON / Sezary Monitoring Flow Cytometry, Blood.

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

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

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

Specimen Volume: 6 mL

Collection Instructions:

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

2. Label specimen as blood.

Forms

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. The minimum volume is sufficient for one attempt at testing.

1 mL

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

Gross hemolysis Reject
Gross lipemia OK

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 (preferred) 4 days
Refrigerated 4 days

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

Identifying immunophenotypically aberrant T-cell populations with restricted expression of T-cell receptor beta-chain constant in peripheral blood, to roughly assess the circulating tumor burden in cutaneous T-cell lymphomas

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

This Sezary panel is ordered for patients with a clinical suspicion of Sezary syndrome or cutaneous T-cell lymphoma with peripheral blood involvement without a previously confirmed diagnosis. A Triage panel and Sezary panel will always be performed. This test is not indicated for monitoring peripheral blood involvement in patients with a diagnosis of Sezary syndrome or mycosis fungoides. For monitoring purposes, order SZMON / Sezary Monitoring Flow Cytometry, Blood.

 

The panel is charged based on 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 testing process begins with a triage panel to evaluate for and exclude monotypic B cells or increased numbers of blasts. The triage panel also includes antibodies to assess the number of CD3-positive T cells and CD16-positive/CD3-negative natural killer cells present. Additional reflex testing may occur to fully characterize a disease state per algorithmic approach or clarify any abnormalities from the screening test at an additional charge for each marker tested (ADD1 if applicable). For a comprehensive list of potential additional panels, refer to LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies.

 

The Sezary panel will further evaluate the T cells for expression of CD2, CD4, CD5, CD7, CD8, CD26, and TRBC1.

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

Sezary syndrome (SS) and mycosis fungoides (MF) are two distinct but intimately related T-cell lymphoproliferative disorders involving the skin and are commonly referred to as cutaneous T-cell lymphomas (CTCLs). SS is defined by the triad of erythroderma, generalized lymphadenopathy, and the presence of circulating cells with irregular nuclear features (Sezary cells). MF typically presents with slowly progressing patch and plaque lesions. Detection of neoplastic CD4-positive T cells in peripheral blood (>1000 cells/microliter) is essential to establish a diagnosis of SS. Disease staging and assessment of therapy response in CTCL require a quantitative assessment of peripheral blood involvement in absolute number of neoplastic cells (Sezary cells) per microliter. Flow cytometry is now considered the method of choice to estimate the number of Sezary cells in peripheral blood, largely replacing the less reproducible and time-consuming morphologic quantitation of atypical lymphocytes on a peripheral blood smear, proposed by the International Society for Cutaneous Lymphomas, and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer. Typically, Sezary cells are immunophenotypically distinct and they are clonal.

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, if available, morphologic features will be provided by a board-certified hematopathologist for every case.

Interpretation
Provides information to assist in interpretation of the test results

An immunophenotypically distinct T-cell population is suggestive of clonality when the subset exhibits a restricted T-cell receptor beta-chain constant (TRBC) staining pattern defined as either 1) >85% of TRBC1-positive events, 2) <15% TRBC1-positive events, or 3) homogenous TRBC1-dim expression. The immunophenotype of the distinct T-cell population, its percentage of total lymphocytes, and its percentage of total analyzed events will be reported. The test will be resulted as "No phenotypically aberrant T-cell population detected" if there is no specific immunophenotype that allows the detection of TRBC-restricted T cells.

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

Correlation with clinical features is necessary for diagnosis of Sezary syndrome. This analysis can only describe a cell population with aberrant phenotype, but the significance of this finding in isolation is uncertain.

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

1. Horna P, Deaver DM, Qin D, et al. Quantitative flow cytometric identification of aberrant T cell clusters in erythrodermic cutaneous T cell lymphoma. Implications for staging and prognosis. J Clin Pathol. 2014;67(5):431-436

2. Berg H, Otteson GE, Corley H, et al. Flow cytometric evaluation of TRBC1 expression in tissue specimens and body fluids is a novel and specific method for assessment of T-cell clonality and diagnosis of T-cell neoplasms. Cytometry B Clin Cytom. 2021;100(3):361-369

3. Horna P, Shi M, Olteanu H, Johansson U. Emerging role of T-cell receptor constant beta chain-1 (TRBC1) expression in the flow cytometric diagnosis of T-cell malignancies. Int J Mol Sci. 2021;22(4):1817

4. Wilcox RA. Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(1):152-165. doi:10.1002/ajh.24233

5. Horna P, Olteanu H, Jevremovic D, et al. Single-antibody evaluation of T-cell receptor beta constant chain monotypia by flow cytometry facilitates the diagnosis of T-cell large granular lymphocytic leukemia. Am J Clin Pathol. 2021;156(1):139-148

6. Horna P, Shi M, Jevremovic D, Craig FE, Comfere NI, Olteanu H. Utility of TRBC1 expression in the diagnosis of peripheral blood involvement by cutaneous T-cell lymphoma. J Invest Dermatol. 2021;141(4):821-829

7. Scarisbrick JJ, Hodak E, Bagot M, et al. Blood classification and blood response criteria in mycosis fungoides and Sezary syndrome using flow cytometry: recommendations from the EORTC cutaneous lymphoma task force. Eur J Cancer. 2018;93:47-56

8. Illingworth A, Johansson U, Huang S, et al. International guidelines for the flow cytometric evaluation of peripheral blood for suspected Sézary syndrome or mycosis fungoides: Assay development/optimization, validation, and ongoing quality monitors. Cytometry B Clin Cytom. 2021;100(2):156-182

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

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

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

-Sezary Panel: CD2, CD3, CD4, CD5, CD7, CD8, CD26, CD45, and TRBC1.(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)

-Possible additional panels performed per algorithmic approach.

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 3 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

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.

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  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • 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)

88188-Flow Cytometry Interpretation, 9 to15 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
SZDIA Sezary Diagnostic Flow Cytometry, B 101118-8
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.
CK126 Sezary Diagnostic No LOINC Needed
CK127 Final Diagnosis 50398-7
CK128 Special Studies 30954-2
CK129 Microscopic Description 22635-7

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