Test Catalog

Test Id : TALFP

Pediatric T-Lymphoblastic Leukemia/Lymphoma Panel, FISH, Varies

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

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
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 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
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

Pediatric T-ALL/LBL panel, FISH

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

TAL1/STIL (1p33) rearrangement or TAL/SIL

t(5;14)(q35;q32)-TLX3::BCL11B or TLX3/BCL11B or HOX11L2/BCL11B

TRB-T-cell receptor beta - (7q34) rearrangement

t(6;7)(q23;q34) TRB::MYB or MYB/TRB

t(7;10)(q34;q24) TRB::TLX1 or TRB/TLX1

t(7;11)(q34;p15) TRB::LMO1 or TRB/LMO1

t(7;11)(q34;p13) TRB::LMO2 or TRB/LMO2

t(9;22)(q34;q11)-BCR::ABL1 or BCR/ABL1

ABL1 (9q34) rearrangement

ABL1 (9q34) amplification

t(10;11)(p12;q14)-PICALM/MLLT10 or MLLT10/PICALM or AF10/PICALM

KMT2A (11q23) rearrangement or MLL

t(4;11)(q21;q23)-KMT2A::AFF1 or AFF1/KMT2A or AFF1/MLL or AF4/MLL

t(6;11)(q27;q23)-KMT2A::AFDN or AFDN/KMT2A or MLLT4/MLL or AF6/MLL

t(9;11)(p21;q23)-KMT2A::MLLT3 or MLLT3/KMT2A or MLLT3/MLL or AF9/MLL

t(10;11)(p12;q23) -KMT2A::MLLT10 or MLLT10/KMT2A or MLLT10/MLL or AF10/MLL

t(11;19)(q23;p13.3)-KMT2A::MLLT1 or KMT2A/MLLT1 or MLL/MLLT1 or MLL/ENL

t(11;19)(q23;p13.1)-KMT2A::ELL or KMT2A/ELL or MLL/ELL

TRA - T-cell receptor alpha - (7q34) rearrangement

t(8;14)(q24.21;q11.2) TRA::MYC or MYC/TRA or MYC/TRAD

t(10;14)(q24;q11.2) TRA::TLX1 or TLX1/TRA or TLX1/TRAD

t(11;14)(p15;q11.2) TRA::LMO1 or LMO1/TRA or LMO1/TRAD

t(11;14)(p13;q11.2) TRA::LMO2 or LMO2/TRA or LMO2/TRAD

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 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.

Specimen Type
Describes the specimen type validated for testing

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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC159 Reason for Referral
GC160 Specimen Whole blood ACD
Bone marrow ACD
Whole blood Na Hep
Bone marrow Na Hep
Whole blood EDTA
Bone marrow EDTA

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 (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.

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.

Bone marrow: 1 mL; Whole blood: 2 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, 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
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 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.

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

In the United States, the incidence of acute lymphoblastic leukemia (ALL) is roughly 6000 new cases per year (as of 2019). ALL accounts for approximately 70% of all childhood leukemia cases (aged 0 to 19 years), making it the most common childhood cancer.

 

Approximately 85% of pediatric cases of ALL are of B-cell lineage (B-ALL) and 15% are of T-cell lineage (T-ALL). T-ALL is more common in adolescents than younger children and accounts for 25% of adult ALL. When occurring as a primary lymphoblastic lymphoma (LBL), approximately 90% are T-cell lineage versus only 10% B-cell lineage. T-LBL often present as a mediastinal mass in younger patients with or without concurrent bone marrow involvement.

 

An abnormal karyotype is found in 50% to 70% of T-ALL cases, although many of the classic abnormalities are "cryptic" by conventional chromosome studies and must be identified by fluorescence in situ hybridization studies (FISH) and are associated with various prognoses. One predictive marker, amplification of the ABL1 gene region, has been identified in 5% of T-ALL, and these patients may be responsive to targeted tyrosine kinase inhibitors.

 

A summary of the characteristic chromosome abnormalities identified in T-ALL are listed in the following table.

 

Table. Common Chromosome Abnormalities in T-cell Acute Lymphoblastic Leukemia/Lymphoma

 

Cytogenetic change

Genes involved

del(1p33)

TAL1/STIL

t(5;14)(q35;q32)

TLX3::BCL11B

t(5q32;var)

PDGFRB

t(10;11)(p13;q14)

PICALM::MLLT10

Episomal amplification

ABL1

t(9p24.1;var)

JAK2

t(9q34;var)

ABL1

t(11q23;var)

KMT2A

t(4;11)(q21;q23)

KMT2A::AFF1

t(6;11)(q27;q23)

KMT2A::AFDN

t(9;11)(p21.3;q23)

KMT2A::MLLT3

t(10;11)(p13;q23)

KMT2A::MLLT10

t(11;19)(q23;p13.1)

KMT2A::ELL

t(11;19)(q23;p13.3)

KMT2A::MLLT1

t(7q34;var)

TRB

t(6;7)(q23;q34)

TRB::MYB

t(7;10)(q34;q24)

TRB ::TLX1

t(7;11)(q34;p15)

TRB ::LMO1

t(7;11)(q34;p13)

TRB ::LMO2

t(14q11.2;var)

TRA

t(8;14)(q24.21;q11.2)

TRA::MYC

t(10;14)(q24;q11.2)

TLX1::TRA

t(11;14)(p15;q11.2)

LMO1::TRA

t(11;14)(p13;q11.2)

LMO2 ::TRA

del(17p)

TP53

Complex karyotype (> or =4 abnormalities)

 

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 set.

 

The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.

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 US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

 

Fluorescence in situ hybridization (FISH) is not a substitute for conventional chromosome studies because the latter detects chromosome abnormalities associated with other hematological disorders that would go undetected in a targeted T-ALL FISH panel test.

 

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

 

If no FISH signals are observed post-hybridization, the case will be released indicating a lack of FISH results.

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

1. WHO Classification of Tumours Editorial Board, eds. Haematolymphoid tumours. 5th ed. IARC Press; 2024. WHO Classification of Tumours, Volume 11

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(4):738-745

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

4. Graux C, Cools J, Michaux L, et al. Cytogenetics and molecular genetics of T-cell acute lymphoblastic leukemia: from thymocyte to lymphoblast. Leukemia. 2006;20:1496-1510

5. Liu Y, Easton J, Shao Y, et al. The genomic landscape of pediatric and young adult T-lineage acute lymphoblastic leukemia. Nat Genet. 2017;49(8):1211-1218

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

This test is performed using commercially available and laboratory-developed probes. Rearrangements involving TAL1/STIL, TRB, ABL1, KMT2A, and TRA are detected using a dual-color break-apart (BAP) strategy probe set. Dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe sets are used to detect t(5;14), t(9;22), t(10;11), and in reflex testing when rearrangements of KMT2A, TRB, or TRA genes are detected. Amplification of the ABL1 gene region is detected using a D-FISH probe strategy. For enumeration and BAP strategy probe sets, 100 interphase nuclei are scored; 200 interphase nuclei are scored when D-FISH probes are used. All results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)

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

Mayo Clinic Laboratories - Rochester Main Campus
CLIA Number: 24D0404292

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 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 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
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.

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

88271x2, 88275x1-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
TALFP Pediatric T-ALL/LBL panel, FISH 101663-3
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.
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

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

Test Update Resources

Change Type Effective Date
New Test 2025-09-09