Test Catalog

Test Id : CILMF

Congenital Infantile Leukemia, Specified 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 and classic rearrangements seen in infant patients with leukemia using client specified probe sets

 

An adjunct to conventional chromosome studies in infant patients with leukemia.

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
CILMB Probe, Each Additional (CILMF) 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 1 probe set (2 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following primary or reflex probes will be performed; reflex probes are noted with an asterisk*: Reflex probes can be added, as requested, but remain optional.

11q23 rearrangement, MLL (KMT2A)

*t(4;11)(q21;q23) AFF1/MLL

*t(6;11)(q27;q23) MLLT4(AFDN)/MLL

*t(9;11)(p22;q23) MLLT3/MLL

*t(10;11)(p12;q23) MLLT10/MLL

*t(11;19)(q23;p13.1) MLL/ELL

*t(11;19)(q23;p13.3) MLL/MLLT1

t(8;16), KAT6A/CREBBP

*D8Z2/MYC for trisomy 8

t(1;22), RBM15/MKL1

+13/+21, 13q14 and 21q22

inv(16), MYH11/CBFB

*16q22 rearrangement, CBFB break-apart

t(8;21), [M2], RUNX1T1/RUNX1

t(15;17), [M3], PML/RARA

*17q21 rearrangement, RARA break-apart

-5/5q-, D5S630/EGR1

-7/7q-, D7Z1/ D7S486

inv(3) or t(3;3), RPN1/MECOM

*3q26.2 rearrangement, MECOM break-apart

t(6;9), DEK/NUP214

12p13 rearrangement, ETV6 break-apart

*t(7;12)(q36;p13), MNX1/ETV6

inv(16), GLIS2/CBFA2T3

11p15.4 rearrangement, NUP98 break-apart

*t(7;11)(p15;p15.4), HOXA9/NUP98

+9/9p-, CDKN2A/D9Z1

t(9;22) BCR/ABL1, ABL1 amplification

*9q34 rearrangement, ABL1 break-apart

-17/17p-, TP53/D17Z1

t(1;19)(q23;p13), PBX1/TCF3

Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1

t(12;21)(p13;q22), ETV6/RUNX1 fusion, iAMP21

*12p13 rearrangement, ETV6 break-apart

14q32 rearrangement, IGH break-apart

t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement

*t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32), CRLF2/IGH

t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement

8q24.1 rearrangement, MYC break-apart

1q25 rearrangement, ABL2 break-apart

5q32 rearrangement, PDGFRB break-apart

9p24.1 rearrangement, JAK2 break-apart

9q34 rearrangement, ABL1 break-apart

7p-, IKZF1/CEP7

t(5;14), TLX3/BCL11B

7q34 rearrangement, TRB break-apart

*t(6;7) - MYB/TRB fusion

*t(7;10) - TRB/TLX1

*t(7;11) - TRB/LMO1

*t(7;11) - TRB/LMO2

14q11.2 rearrangement, TRAD break-apart

*t(8;14) - MYB/TRAD

*t(10;14) - TLX1/TRAD

*t(11;14) - LMO1/TRAD

*t(11;14) - LMO2/TRAD

t(10;11), MLLT10/PICALM

1p33 rearrangement, TAL1/STIL

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

Cong Infantile Leukemia, Spec FISH

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

-5 (monosomy 5)

-7 (monosomy 7)

NUP98 rearrangement

5q- (5q deletion)

7q- (7q deletion)

Acute Promyelocytic Leukemia (APL)

inv(16) - inv(16) - MYH11/CBFB

inv(3) - inv(3) - RPN1/MECOM or RPN1/EVI

MLL or KMT2A (11q23) rearrangement

t(1;22)(p13.3;q13.1q13.2) - RBM15/MKL1

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(10;11)(p13;q23) - MLLT10/MLL or AF10/MLL

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

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

t(15;17)(q24.1;q21) - PML/RARA

t(16;16)(p13.1;q22) - MYH11/CBFB

t(3;3)(q21.3;q26.2) - RPN1/MECOM or RPN1/EVI1

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

t(6;9)(p23;q34) - DEK/NUP214 or DEK/CAN

t(7;11)(p15;p15.4) - HOXA9/NUP98

t(8;16)(p11.2;p13.3) - KAT6A/CREBBP or MYST3/CREBBP

t(8;21)(q22;q22) - RUNX1T1/RUNX1 or ETO/AML1

t(9;11)(p22;q23) - MLLT3/MLL or AF9/MLL

inv(16)(p24.3;p13.3) - GLIS2/CBFA2T3

+4,+10,+17

17p- (17p deletion) or TP53

9p- (9p deletion) or CDKN2A or p16

ABL1 (9q34) rearrangement

ABL2 (1q25) rearrangement

BCR-ABL1 like ALL

CRLF2 (Xp22.33) or (Yp11.32) rearrangement

Hyperdiploidy

Hypodiploid/pseudo-hyperdiploid

Hypotriploid/Near-Triploid

iAMP21 or RUNX1 amplification

IGH (14q32) rearrangement

IKZF1 deletion

JAK2 (9p24.1) rearrangement

MYC (8q24.1) rearrangement

P2RY8 (Xp22.33) or (Yp11.32) rearrangement

Ph-like ALL

t(1;19)(q23;p13.3) - PBX1/TCF3

t(12;21)(p13;q22) - TEL/AML1 or ETV6/RUNX1

t(9;22)(9q34;q11.2) - BCR/ABL1

t(X;14)(p22.33;q32) - CRLF2/IGH

t(Y;14)(p11.32;q32) - CRLF2/IGH

ETV6 rearrangement, ETV6

ABL1 amplification

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

t(10;14)(q24;q11.2) - TLX1/TRAD or HOX11/TRAD

t(11;14)(p13;q11.2) - LMO2/TRAD

t(11;14)(p15;q11.2) - LMO1/TRAD

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

t(6;7)(q23;q34) - MYB/TRB

t(7;10)(q34;q24) - TRB/TLX1

t(7;11)(q34;p13) - TRB/LMO2

t(7;11)(q34;p15) - TRB/LMO1

t(8;14)(q24.1;q11.2) - MYC/TRAD

T-cell receptor alpha/delta (TRAD) (14q11.2) rearrangement

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

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

PDGFRB (5q32) 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 1 probe set (2 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following primary or reflex probes will be performed; reflex probes are noted with an asterisk*: Reflex probes can be added, as requested, but remain optional.

11q23 rearrangement, MLL (KMT2A)

*t(4;11)(q21;q23) AFF1/MLL

*t(6;11)(q27;q23) MLLT4(AFDN)/MLL

*t(9;11)(p22;q23) MLLT3/MLL

*t(10;11)(p12;q23) MLLT10/MLL

*t(11;19)(q23;p13.1) MLL/ELL

*t(11;19)(q23;p13.3) MLL/MLLT1

t(8;16), KAT6A/CREBBP

*D8Z2/MYC for trisomy 8

t(1;22), RBM15/MKL1

+13/+21, 13q14 and 21q22

inv(16), MYH11/CBFB

*16q22 rearrangement, CBFB break-apart

t(8;21), [M2], RUNX1T1/RUNX1

t(15;17), [M3], PML/RARA

*17q21 rearrangement, RARA break-apart

-5/5q-, D5S630/EGR1

-7/7q-, D7Z1/ D7S486

inv(3) or t(3;3), RPN1/MECOM

*3q26.2 rearrangement, MECOM break-apart

t(6;9), DEK/NUP214

12p13 rearrangement, ETV6 break-apart

*t(7;12)(q36;p13), MNX1/ETV6

inv(16), GLIS2/CBFA2T3

11p15.4 rearrangement, NUP98 break-apart

*t(7;11)(p15;p15.4), HOXA9/NUP98

+9/9p-, CDKN2A/D9Z1

t(9;22) BCR/ABL1, ABL1 amplification

*9q34 rearrangement, ABL1 break-apart

-17/17p-, TP53/D17Z1

t(1;19)(q23;p13), PBX1/TCF3

Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1

t(12;21)(p13;q22), ETV6/RUNX1 fusion, iAMP21

*12p13 rearrangement, ETV6 break-apart

14q32 rearrangement, IGH break-apart

t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement

*t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32), CRLF2/IGH

t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement

8q24.1 rearrangement, MYC break-apart

1q25 rearrangement, ABL2 break-apart

5q32 rearrangement, PDGFRB break-apart

9p24.1 rearrangement, JAK2 break-apart

9q34 rearrangement, ABL1 break-apart

7p-, IKZF1/CEP7

t(5;14), TLX3/BCL11B

7q34 rearrangement, TRB break-apart

*t(6;7) - MYB/TRB fusion

*t(7;10) - TRB/TLX1

*t(7;11) - TRB/LMO1

*t(7;11) - TRB/LMO2

14q11.2 rearrangement, TRAD break-apart

*t(8;14) - MYB/TRAD

*t(10;14) - TLX1/TRAD

*t(11;14) - LMO1/TRAD

*t(11;14) - LMO2/TRAD

t(10;11), MLLT10/PICALM

1p33 rearrangement, TAL1/STIL

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test is only performed on specimens from patients with acute leukemia who are 18 months of age or younger.

 

This test is intended for instances when limited congenital infantile leukemia fluorescence in situ hybridization (FISH) probes are needed. The FISH probes to be analyzed must be specified on the request, otherwise test processing may be delayed in order to determine the intended analysis.

-If specific probes are not included with this order, the test may be canceled and automatically reordered by the laboratory as CILDF / Congenital Infantile Leukemia, Diagnostic FISH, Varies.

-If this test is ordered on a patient 19 months or older, this test will be canceled and automatically reordered by the laboratory as BALPF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric, Varies ; TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric, Varies; or AMLPF / Acute Myeloid Leukemia (AML), FISH, Pediatric, Varies, based on patient's reason for testing.

-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 COGBF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies; COGTF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies; or COGMF / Acute Myeloid Leukemia (AML), Children's Oncology Group Enrollment Testing, FISH, Varies based on the patient's protocol.

 

If the entire congenital infantile leukemia FISH panel is preferred, order CILDF / Congenital Infantile Leukemia, Diagnostic FISH, Varies.

 

At diagnosis, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and a complete CILDF / Congenital Infantile Leukemia, Diagnostic FISH, Varies panel should be performed.

 

For testing paraffin embedded tissue samples from patients with congenital infantile leukemia, order CILPF / Congenital Infantile Leukemia, FISH, Tissue.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

1. A list of probes requested for analysis is required. Probes available for this test are listed in the Testing Algorithm section.

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

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC109 Reason for Referral
GC110 Probes Requested
GC111 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.

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 (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

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 and classic rearrangements seen in infant patients with leukemia using client specified probe sets

 

An adjunct to conventional chromosome studies in infant patients with leukemia.

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 1 probe set (2 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following primary or reflex probes will be performed; reflex probes are noted with an asterisk*: Reflex probes can be added, as requested, but remain optional.

11q23 rearrangement, MLL (KMT2A)

*t(4;11)(q21;q23) AFF1/MLL

*t(6;11)(q27;q23) MLLT4(AFDN)/MLL

*t(9;11)(p22;q23) MLLT3/MLL

*t(10;11)(p12;q23) MLLT10/MLL

*t(11;19)(q23;p13.1) MLL/ELL

*t(11;19)(q23;p13.3) MLL/MLLT1

t(8;16), KAT6A/CREBBP

*D8Z2/MYC for trisomy 8

t(1;22), RBM15/MKL1

+13/+21, 13q14 and 21q22

inv(16), MYH11/CBFB

*16q22 rearrangement, CBFB break-apart

t(8;21), [M2], RUNX1T1/RUNX1

t(15;17), [M3], PML/RARA

*17q21 rearrangement, RARA break-apart

-5/5q-, D5S630/EGR1

-7/7q-, D7Z1/ D7S486

inv(3) or t(3;3), RPN1/MECOM

*3q26.2 rearrangement, MECOM break-apart

t(6;9), DEK/NUP214

12p13 rearrangement, ETV6 break-apart

*t(7;12)(q36;p13), MNX1/ETV6

inv(16), GLIS2/CBFA2T3

11p15.4 rearrangement, NUP98 break-apart

*t(7;11)(p15;p15.4), HOXA9/NUP98

+9/9p-, CDKN2A/D9Z1

t(9;22) BCR/ABL1, ABL1 amplification

*9q34 rearrangement, ABL1 break-apart

-17/17p-, TP53/D17Z1

t(1;19)(q23;p13), PBX1/TCF3

Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1

t(12;21)(p13;q22), ETV6/RUNX1 fusion, iAMP21

*12p13 rearrangement, ETV6 break-apart

14q32 rearrangement, IGH break-apart

t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement

*t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32), CRLF2/IGH

t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement

8q24.1 rearrangement, MYC break-apart

1q25 rearrangement, ABL2 break-apart

5q32 rearrangement, PDGFRB break-apart

9p24.1 rearrangement, JAK2 break-apart

9q34 rearrangement, ABL1 break-apart

7p-, IKZF1/CEP7

t(5;14), TLX3/BCL11B

7q34 rearrangement, TRB break-apart

*t(6;7) - MYB/TRB fusion

*t(7;10) - TRB/TLX1

*t(7;11) - TRB/LMO1

*t(7;11) - TRB/LMO2

14q11.2 rearrangement, TRAD break-apart

*t(8;14) - MYB/TRAD

*t(10;14) - TLX1/TRAD

*t(11;14) - LMO1/TRAD

*t(11;14) - LMO2/TRAD

t(10;11), MLLT10/PICALM

1p33 rearrangement, TAL1/STIL

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

While pediatric leukemia is the most common malignancy affecting children, acute leukemia occurring prior to the age of 18 months (infant leukemia) or occurring within the first 3 months of life (congenital leukemia) is relatively rare in occurrence. The incidence of congenital and infant acute leukemia cases (through 12 months of age) is estimated at only 30 to 40 cases/million/year, with the majority comprising infant cases. Nearly all cases of congenital and infant acute leukemia represent either acute myeloid leukemia (AML) or B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) with only very rare cases of T-cell acute lymphoblastic leukemia/lymphoma identified in this age group.

 

Characteristic genetic abnormalities have been identified in both the congenital acute leukemia and infant acute leukemia setting, each with uniquely associated clinical-pathologic correlations. Rare but important patients with KAT6A/CREBBP translocations and congenital acute leukemia have been described with spontaneously remitting AML despite the lack of therapeutic intervention. In addition, transient abnormal myelopoiesis associated with Down syndrome is another common manifestation encountered in the neonatal setting that can be associated with the development of infant acute leukemia. In contrast, nearly 80% of infant acute leukemia cases are associated with MLL(KMT2A) translocation events with varying percentages of translocation partners based on an AML versus B-ALL/LBL presentation.

 

Due to the underlying genetic heterogeneity associated with both congenital and infant leukemia and the important prognostic, diagnostic and occasional therapeutic targets identified, appropriate genetic characterization of this uncommon acute leukemia presentation is critical. These thorough fluorescence in situ hybridization (FISH) panels have been developed by Mayo Clinic Laboratories to interrogate the more common AML and B-ALL abnormalities associated with both congenital and infant acute leukemias. These FISH probes have been validated both in bone marrow/blood (CILDF / Congenital Infantile Leukemia, Diagnostic FISH, Varies) and in paraffin (CILPF / Congenital Infantile Leukemia, FISH, Tissue), since a significant minority of these patients present clinically with isolated extramedullary (tissue) manifestations (ie, myeloid sarcoma).

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.

 

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 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 be missed by this FISH panel test.

 

Bone marrow is the preferred sample type for this FISH 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

Each probe was independently tested and verified on unstimulated peripheral blood and bone marrow specimens. Normal cutoffs were calculated based on the results of 25 normal specimens. Each probe set was evaluated to confirm the probe set detected the abnormality it was designed to detect.

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. Vol 2. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC Press; 2017

2. Tomizawa D: Recent progress in the treatment of infant acute lymphoblastic leukemia. Pediatr Int. 2015;57(5):811-819. doi: 10.1111/ped.12758

3. Inaba H, Zhou Y, Abla O, et al: Heterogeneous cytogenetic subgroups and outcomes in childhood acute megakaryoblastic leukemia: a retrospective international study. Blood. 2015;126(13):1575-84. doi: 10.1182/blood-2015-02-629204

4. Coenen EA, Zwaan CM, Reinhardt D, et al: Pediatric acute myeloid leukemia with t(8;16)(p11;p13), a distinct clinical and biological entity: a collaborative study by the International-Berlin-Frankfurt-Munster AML-study group. Blood. 2013;122(15):2704-13. doi: 10.1182/blood-2013-02-485524

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. Gain or loss of chromosomes 4, 5, 7, 8, 13, 17, and 21 are detected using enumeration strategy probes. Deletion of the CDKN2A locus on chromosome 9, TP53 on chromosome 17, and deletion of IKZF1 on chromosome 7 are detected using an enumeration strategy.

 

Rearrangements involving the following genes: MLL (KMT2A), NUP98, ETV6, CBFB, RARA, ABL2, PDGFRB, MYC, JAK2, ABL1, IGH, CRLF2, P2RY8, TAL1/STIL, TRB, and TRAD are detected using a dual-color break-apart (BAP) strategy probe. If a MYC gene region separation is identified, break-apart BCL2 and BCL6 will be evaluated using a dual-color break-apart (BAP) strategy probe. Dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe sets are used to detect inv(3), inv(16), t(8;21), t(15;17), t(6;9), t(8;16), t(3;21), t(1;3), t(1;22), t(7;11), t(7;12), t(9;22), t(12;21), t(1;19), t(5;14), t(9;22), t(10;11), and in reflex testing when a rearrangement of the MLL, TRB, TRAD gene region is observed. Amplification of ABL1 (9q34) or RUNX1 (iAMP21; 21q22) 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

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 x2, 88275 x1, 88291 x1-FISH Probe, Analysis, Interpretation; 1 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
CILMF Cong Infantile Leukemia, Spec 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.
614241 Result Summary 50397-9
614242 Interpretation 69965-2
614243 Result Table 93356-4
614244 Result 62356-1
GC109 Reason for Referral 42349-1
GC110 Probes Requested 78040-3
GC111 Specimen 31208-2
614245 Source 31208-2
614246 Method 85069-3
614247 Additional Information 48767-8
614248 Disclaimer 62364-5
614249 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