Test Catalog

Test Id : SZDIA

Sezary Diagnostic Flow Cytometry, Blood

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

Identifying phenotypically aberrant T-cell population in peripheral blood as part of the diagnostic workup for Sezary syndrome

 

Roughly assessing the circulating tumor burden in mycosis fungoides, if the phenotype of the neoplastic cells is distinctive enough

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 in cases of suspected Sezary syndrome or cutaneous T-cell lymphoma (CTCL) with peripheral blood involvement. For cases without a previously confirmed diagnosis of Sezary syndrome, a triage panel will also be performed to exclude a B-cell lymphoproliferative disorder.

 

A triage panel is always performed. 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).

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 in cases of suspected Sezary syndrome or cutaneous T-cell lymphoma (CTCL) with peripheral blood involvement. For cases without a previously confirmed diagnosis of Sezary syndrome, a triage panel will also be performed to exclude a B-cell lymphoproliferative disorder.

 

A triage panel is always performed. 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).

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

This test is not appropriate for monitoring patients with a diagnosis of Sezary syndrome; order SZMON / Sezary Monitoring Flow Cytometry, Blood in that situation.

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

Collection Container/Tube:

Preferred: Yellow top (ACD)

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

Specimen Volume: 6 mL

Collection Instructions:

1. Send in original tube. Do not transfer blood to other containers.

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

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) 72 hours
Refrigerated 72 hours

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

Identifying phenotypically aberrant T-cell population in peripheral blood as part of the diagnostic workup for Sezary syndrome

 

Roughly assessing the circulating tumor burden in mycosis fungoides, if the phenotype of the neoplastic cells is distinctive enough

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

This Sezary panel is ordered in cases of suspected Sezary syndrome or cutaneous T-cell lymphoma (CTCL) with peripheral blood involvement. For cases without a previously confirmed diagnosis of Sezary syndrome, a triage panel will also be performed to exclude a B-cell lymphoproliferative disorder.

 

A triage panel is always performed. 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).

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

Sezary syndrome is a leukemic form of cutaneous T-cell lymphoma (CTCL). By definition, it is associated with systemic skin involvement (erythroderma) and the presence of at least 1000/mcL of circulating cells with irregular nuclear features (Sezary cells). Morphologic assessment of the number of Sezary cells has been proven to have low reproducibility. Therefore, WHO/European Organization for Research and Treatment of Cancer (EORTC) classification of skin tumors adopted alternative methods to assess circulating T-cells in order to establish the diagnosis of Sezary syndrome. These include CD4:CD8 ratio of more than 10:1, and selective loss of CD7 and/or CD26 on 40% and 30% of the CD4-positive cell population, respectively. It is important to recognize that the later criteria (fulfilled by peripheral blood flow cytometry immunophenotyping) are relative, and not in direct correlation with absolute counts of Sezary cells defined by morphology.

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

Sezary cells typically show loss of CD7 and/or CD26. As loss of these markers is not completely sensitive or specific for Sezary cells, and there are circulating normal CD4-positive T-cells, which usually cannot be excluded from the analysis, the WHO/European Organization for Research and Treatment of Cancer (EORTC) classification of skin tumors proposed cutoffs of 30% for CD26 loss and 40% for CD7 loss on CD4-positive T-cells as diagnostic criteria for Sezary syndrome. In addition, a CD4:CD8 ratio of greater than or equal to 10:1 in a gated T-cell population is also considered abnormal and part of the diagnostic algorithm for Sezary syndrome.

 

In mycosis fungoides staging studies the cutoffs are even less clearly defined. The clinical outcome was worse in patients with more than 5% of circulating lymphocytes showing Sezary-like morphology. However, flow cytometry immunophenotyping is deemed useful for relative quantification of these cells only if they can be separated by aberrant expression of other surface markers. In the majority of cases, this cannot be accomplished to the proposed cutoff point (5% of circulating lymphocytes).

 

The test will be resulted as "No phenotypically aberrant T-cell population detected" if there is no specific phenotype that allows separation of potentially abnormal CD4-positive T-cells, loss of CD26 (and/or CD7) is present in less than 30% (40%), and CD4:CD8 ratio is less than 10:1. If any of the above aberrancies are present, the test will be resulted as "Phenotypically distinct T-cell population is detected" with a description of phenotype, percentage of total CD4-positive population, and percentage of total analyzed events. In addition, the phenotype will be compared to that of any distinct T-cell population previously seen in the same patient by our laboratory.

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. Honra 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;67:431-436

2. Vaughan J, Harrington AM, Hari PN, et al: Immunophenotypic stability of Sezary cells by flow cytometry: usefulness of flow cytometry in assessing response to and guiding alemtuzumab therapy. Am J Clin Pathol. 2012 Mar;137(3):403-411

3. Kelemen K, Guitart J, Kuzel TM, et al: The usefulness of CD26 in flow cytometric analysis of peripheral blood in Sezary syndrome. Am J Clin Pathol. 2008 Jan;129(1):146-156

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

5. Olsen E, Vonderheid E, Pimpinelli N, et al: Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-1722

6. Willemze R, Jaffe ES, Burg G, et al: WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105:3768-3785

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 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 Jan;98(1):99-107)

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.

  • 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)

88188-Flow Cytometry Interpretation, 9 to15 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