Test Catalog

Test Id : TLPDF

T-Cell Lymphoma, Diagnostic FISH, Varies

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

Detecting a neoplastic clone associated with the common chromosome abnormalities observed in patients with various T-cell lymphomas using a laboratory-designated probe set algorithm

 

Tracking known chromosome abnormalities and response to therapy in patients with T-cell lymphoma

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

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
TLPDB Probe, Each Additional (TLPDF) No, (Bill Only) No

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

This test includes a charge for the probe application, analysis, and professional interpretation of results for 3 probe sets (6 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

When this test and flow cytometry testing for leukemia/lymphoma are ordered concurrently, the flow cytometry result will be utilized to determine if sufficient clonal T-cells are available for FISH testing. If the result does not identify a sufficient clonal T-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

 

If FISH testing proceeds, all probes in the initial panel will be performed. The initial panel includes testing for the following abnormalities using the probes listed:

14q32.1 rearrangement, TCL1A break-apart

14q11.2 rearrangement, TRAD break-apart**

i(7q), D7Z1/D7S486

+8, D8Z2/MYC

 

**When a TCL1A rearrangement is not identified and the patient has T-cell prolymphocytic leukemia/lymphoma (T-PLL), reflex testing using the TRAD break-apart probe set will be performed.

 

See Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm, see in Special Instructions.

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

Fluorescence In Situ Hybridization (FISH)

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

T-cell Lymphoma B/BM, Diag FISH

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

+8 (trisomy 8)

Hepatosplenic T-cell Lymphoma

inv(14) - inversion 14

Iso(7q) - isochromosome 7q

T-cell Prolymphocytic Leukemia (T-PLL)

TCL1A (14q32) rearrangement

TRAD (14q11.2) rearrangement

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

This test includes a charge for the probe application, analysis, and professional interpretation of results for 3 probe sets (6 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

When this test and flow cytometry testing for leukemia/lymphoma are ordered concurrently, the flow cytometry result will be utilized to determine if sufficient clonal T-cells are available for FISH testing. If the result does not identify a sufficient clonal T-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

 

If FISH testing proceeds, all probes in the initial panel will be performed. The initial panel includes testing for the following abnormalities using the probes listed:

14q32.1 rearrangement, TCL1A break-apart

14q11.2 rearrangement, TRAD break-apart**

i(7q), D7Z1/D7S486

+8, D8Z2/MYC

 

**When a TCL1A rearrangement is not identified and the patient has T-cell prolymphocytic leukemia/lymphoma (T-PLL), reflex testing using the TRAD break-apart probe set will be performed.

 

See Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm, see in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test is intended for instances when a non-specific T-cell lymphoma fluorescence in situ hybridization (FISH) panel is needed.

 

If limited T-cell lymphoma FISH probes are preferred, order TLPMF / T-Cell Lymphoma, Specified FISH, Varies.

 

This test should only be ordered if the sample is known to have a sufficient clonal T-cell population. If a flow cytometry result is available and does not identify a sufficient clonal T-cell population, this test will be canceled, and no charges will be incurred.

 

For testing paraffin-embedded tissue samples from patients with T-lymphoblastic lymphoma (T-BLB), see TLBLF / T-Lymphoblastic Leukemia/Lymphoma, FISH, Tissue.

 

For patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), order either TALAF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies. or TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL), FISH, Pediatric, Varies depending on the age of the patient.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

A reason for testing and a flow cytometry and/or a bone marrow pathology report should be submitted with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC138 Reason for Referral
GC139 Specimen Whole blood ACD
Bone marrow ACD

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

Submit only 1 of the following specimens:

 

Preferred

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (heparin) or lavender top (EDTA)

Specimen Volume: 2-3 mL

Collection Instructions:

1. It is preferable to send the first aspirate from the bone marrow collection.

2. Invert several times to mix bone marrow.

 

Acceptable

Specimen Type: Blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (heparin) or lavender top (EDTA)

Specimen Volume: 6 mL

Collection Instructions: Invert several times to mix blood.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Blood: 2 mL

Bone Marrow: 1 mL

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

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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
Varies Ambient (preferred)
Refrigerated

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

Detecting a neoplastic clone associated with the common chromosome abnormalities observed in patients with various T-cell lymphomas using a laboratory-designated probe set algorithm

 

Tracking known chromosome abnormalities and response to therapy in patients with T-cell lymphoma

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

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

This test includes a charge for the probe application, analysis, and professional interpretation of results for 3 probe sets (6 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

When this test and flow cytometry testing for leukemia/lymphoma are ordered concurrently, the flow cytometry result will be utilized to determine if sufficient clonal T-cells are available for FISH testing. If the result does not identify a sufficient clonal T-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

 

If FISH testing proceeds, all probes in the initial panel will be performed. The initial panel includes testing for the following abnormalities using the probes listed:

14q32.1 rearrangement, TCL1A break-apart

14q11.2 rearrangement, TRAD break-apart**

i(7q), D7Z1/D7S486

+8, D8Z2/MYC

 

**When a TCL1A rearrangement is not identified and the patient has T-cell prolymphocytic leukemia/lymphoma (T-PLL), reflex testing using the TRAD break-apart probe set will be performed.

 

See Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm, see in Special Instructions.

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

T-cell neoplasms are relatively uncommon, accounting for approximately 12% of all non-Hodgkin lymphomas. There are several subtypes of T-cell neoplasms: T-lymphoblastic leukemia (T-ALL), T-cell prolymphocytic leukemia (T-PLL), T-cell large granular lymphocytic leukemia (T-LGL), anaplastic large cell lymphoma (ALCL), peripheral T-cell lymphoma, and various other cutaneous, nodal, and extranodal lymphoma subtypes.

 

There are a few common chromosome abnormalities associated with specific T-cell lymphoma subtypes evaluated by this fluorescence in situ hybridization (FISH) test, as seen in the following table.

 

Table. Common Chromosome Abnormalities in T-cell Lymphomas

Lymphoma subtype

Chromosome abnormality

FISH probe

T-cell prolymphocytic leukemia/lymphoma (T-PLL)

inv(14)(q11q32) and t(14;14)(q11;q32)

5'/3'TCL1A

     Reflex: 14q11.2 rearrangement

5'/3'TRAD

Hepatosplenic T-cell lymphoma

Isochromosome 7q

D7Z1/ D7S486

Trisomy 8

D8Z2/MYC

 

These probes have diagnostic relevance and can also be used to track response to therapy.

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

A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.

 

Detection of an abnormal clone supports a diagnosis of a T-cell lymphoma. The specific abnormality detected may help subtype the neoplasm.

 

The absence of an abnormal clone does not rule out the presence of lymphoma.

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

This test is not approved by the U.S. Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

 

Bone marrow is the preferred sample type for this fluorescence in situ hybridization test. If bone marrow is not available, a blood specimen may be used if there are neoplastic cells in the blood specimen (as verified by a hematopathologist).

Supportive Data

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

1. Swerdlow SH, Campo E, Harris NL, et al, eds: WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. Volume 2. IARC Press; 2017

2. Gesk S, Martin-Subero JI, Harder L, et al: Molecular cytogenetic detection of chromosomal breakpoints in T-cell receptor gene loci. Leukemia. 2003;17:738-745. doi: 10.1038/sj.leu.2402884

3. Chin M, Mugishima H, Takamura M, et al: Hemophagocytic syndrome and hepatosplenic (gamma)(delta) T-cell lymphoma with isochromosome 7q and 8 trisomy. J Pediatr Hematol Oncol. 2004;26(6):375-378. doi: 10.1097/00043426-200406000-00008

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

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 Friday

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.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

4 weeks

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, and its performance characteristics 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.

88271 x6, 88275 x3, 88291 x1- FISH Probe, Analysis, Interpretation; 3 probe set

88271 x2, 88275 x1 - FISH Probe, Analysis; each additional probe set (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
TLPDF T-cell Lymphoma B/BM, Diag FISH In Process
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.
614337 Result Summary 50397-9
614338 Interpretation 69965-2
614339 Result Table 93356-4
614340 Result 62356-1
GC138 Reason for Referral 42349-1
GC139 Specimen 31208-2
614341 Source 31208-2
614342 Method 85069-3
614343 Additional Information 48767-8
614344 Disclaimer 62364-5
614345 Released By 18771-6

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