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Test Code TALFP Pediatric T-Lymphoblastic Leukemia/Lymphoma Panel, FISH, Varies


Ordering Guidance


This test is only performed on specimens from patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) who are 30 years or younger.

 

This test is intended for instances when the entire T-ALL fluorescence in situ hybridization (FISH) panel is needed for a pediatric patient.

 

This test should NOT be used to screen for residual T-ALL/LBL. At follow-up, or if the patient clinically relapses, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone. Additionally, targeted T-ALL FISH probes can be evaluated based on the abnormalities identified in the diagnostic study.

 

If targeted T- ALL FISH probes are preferred, order TALMF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies and request specific probes for targeted abnormalities.

 

If this test is ordered on a patient older than 31 years of age or older, this test will be canceled and automatically reordered by the laboratory as TALAF/ T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies.

 

If this test is ordered and the laboratory is informed that the patient is on a Children's Oncology Group (COG) protocol, this test will be canceled and automatically reordered by the laboratory as COGTF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies.

 

If BALPF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Pediatric, FISH, Varies testing is ordered concurrently with this test, the laboratory may cancel TALPF and automatically reorder as TALMF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies with the following FISH probes: TLX3/BCL11B, break-apart TRB, break-apart TRA, MLLT10/PICALM, TAL1/STIL. If an abnormality is identified that would result in reflex testing in this test, the same reflex testing will be performed in the TALMF. This cancellation is necessary to avoid duplicate testing. Probes for ABL1/BCR and break-apart MLL will still be performed as part of the pediatric/young adult B-ALL FISH panel.

 

For patients with T-cell lymphoma, order TLPFD / T-cell Lymphoma BM/BL panel, Diagnostic, FISH, Varies.

 

For testing paraffin-embedded tissue samples from patients with T-cell lymphoblastic leukemia/lymphoma (T-LBL), order TLBLF / T-Cell Lymphoblastic Leukemia/Lymphoma, FISH, Tissue. If a paraffin-embedded tissue sample is submitted for this test, testing will be canceled and TLBLF will be added and performed as the appropriate test.



Additional Testing Requirements


At diagnosis, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and this fluorescence in situ hybridization (FISH) panel should be performed. If there is limited specimen available, only this FISH test will be performed.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

2. 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.



Specimen Required


Submit only 1 of the following specimens:

 

Preferred

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

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

Specimen Volume: 2 to 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.

3. Send bone marrow specimen in original tube. Do not aliquot.

 

Acceptable

Specimen Type: Whole blood

Container/Tube:

Preferred: Yellow top (ACD)

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

Specimen Volume: 6 mL

Collection Instructions:

1. Invert several times to mix blood.

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


Forms

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

Secondary ID

622420

Useful For

Detecting, at diagnosis, recurrent common chromosome abnormalities associated with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL) in pediatric/young adult patients using a laboratory-designated probe set algorithm

 

As an adjunct to conventional chromosome studies in pediatric/young adult patients with T-ALL

 

Evaluating specimens in which chromosome studies are unsuccessful

 

This test should not be used to screen for residual T-ALL

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for 7 probe sets (14 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

 

This test is performed as panel testing only using the following analysis algorithm.

 

The diagnostic pediatric/young adult T-cell acute lymphoblastic leukemia/lymphoma FISH panel includes testing for the following abnormalities using the FISH probes listed:

ABL1 amplification or t(9;22)(q34;q11.2), ABL1/BCR probe set

t(11q23;var) or KMT2A rearrangement, KMT2A break-apart probe set

1p33 rearrangement or STIL deletion, TAL1/STIL probe set

t(5;14)(q35;q32) or TLX3::BCL11B fusion, TLX3/BCL11B probe set

t(7q34;var) or TRB rearrangement, TRB break-apart probe set

t(14q11.2;var) or TRA rearrangement, TRA break-apart probe set

t(10;11)(p12;q14) or MLLT10::PICALM fusion, MLLT10/PICALM fusion probe set

 

Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes used will have the results included within the final report and will be performed at an additional charge. In the following situations, additional (reflex) testing may be performed at the laboratory's discretion and may be influenced by available karyotype results or other FISH testing.

 

 

When a KMT2A rearrangement is identified, testing with 1 or more dual-fusion (D-FISH) probe sets may be performed in an attempt to identify the translocation partner for the following abnormalities:

t(4;11)(q21;q23) or KMT2A::AFF1 fusion, AFF1/KMT2A probe set

t(6;11)(q27;q23) or KMT2A::AFDN ;fusion, AFDN/KMT2A probe set

t(9;11)(p22;q23) or KMT2A::MLLT3 fusion, MLLT3/KMT2A probe set

t(10;11)(p12;q23) or KMT2A::MLLT10 fusion, MLLT10/KMT2A probe set

t(11;19)(q23;p13.1) or KMT2A::MLLT1 fusion, KMT2A/ELL probe set

t(11;19)(q23;p13.3) or KMT2A::ELL fusion, KMT2A/MLLT1 probe set

 

When a TRA rearrangement is identified, testing in an attempt to identify the translocation partner may be performed. Probes include identification of t(10;14)(q24;q11.2) TRA::TLX1 fusion or t(11;14)(p13;q11.2) TRA::LMO2 fusion.

  

When a TRB rearrangement is identified, testing in an attempt to identify the translocation partner may be performed. Probes include identification of t(7;10)(q34;q24) TRB::TLX1 fusion or t(7;11)(q34;p13) TRB::LMO2 fusion.

 

In the absence of BCR::ABL1 fusion or apparent episomal amplification of ABL1, when an extra or atypical ABL1 signal is identified, testing using the ABL1 break-apart probe set to identify a potential variant translocation involving ABL1, t(9;var)(q34;?) may be performed.

 

For more information see Acute Leukemias of Ambiguous Lineage Testing Algorithm.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

Pediatric T-ALL/LBL panel, FISH

Specimen Type

Varies

Specimen Minimum Volume

Bone marrow: 1 mL; Whole blood: 2 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

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

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88271x14, 88275x7, 88291x1- FISH Probe, Analysis, Interpretation; 7 probe sets

88271x2, 88275x1-FISH Probe, Analysis; each additional probe set (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TALFP Pediatric T-ALL/LBL panel, FISH 101663-3

 

Result ID Test Result Name Result LOINC Value
622421 Result Summary 50397-9
622422 Interpretation 69965-2
622423 Result Table 93356-4
622424 Result 62356-1
GC159 Reason for Referral 42349-1
GC160 Specimen 31208-2
622425 Source 31208-2
622426 Method 85069-3
622427 Additional Information 48767-8
622428 Disclaimer 62364-5
622429 Released By 18771-6