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Test ID LBOR0212 Acute Myeloid Leukemia (AML), Specified FISH, Varies

Useful For

Detecting recurrent common chromosome abnormalities seen in patients with acute myeloid leukemia (AML) using a client-specified probe set

 

An adjunct to chromosome studies in patients with AML

 

Evaluating specimens in which chromosome studies are unsuccessful

Specimen Type

Varies


Ordering Guidance


This test is intended for instances when limited acute myeloid leukemia (AML) fluorescence in situ hybridization (FISH) probes are needed based on specific abnormalities or abnormalities identified in the diagnostic sample. If targeted FISH probes are not included with this test order, test processing will be delayed and the test may be canceled and automatically reordered by the laboratory as either AMLAF / Acute Myeloid Leukemia (AML), FISH, Adult, Varies or AMLPF / Acute Myeloid Leukemia (AML), FISH, Pediatric, Varies depending on the age of the patient.

 

If the entire AML FISH panel is preferred for an adult patient, order AMLAF / Acute Myeloid Leukemia (AML), FISH, Adult, Varies.

 

If the entire AML FISH panel is preferred for a pediatric patient, order AMLPF / Acute Myeloid Leukemia (AML), FISH, Pediatric, Varies.

 

At diagnosis, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and a complete AML FISH panel (either AMLAF or AMLPF) should be performed.

 

Minimal residual disease (MRD) monitoring in patients with acute myeloid leukemia (AML) known to have either t(15;17) with PML::RARA fusion, inv(16) or t(16;16) with MYH11::CBFB fusion,  t(8;21) with RUNX1T1::RUNX1 fusion, or t(9;22) with BCR::ABL1 fusion should be performed by quantitative reverse transcriptase polymerase chain reaction (RT-PCR) and NOT by FISH testing.

 

It is recommended that MRD monitoring in AML patients be performed by AML-MRD Flow cytometry rather than FISH testing using individual FISH probe sets. This is particularly true for the deletion/monosomy probe sets (5, 7, 17) which have cutoffs that exceed 10% of nuclei.

 

If this test is ordered and the laboratory is informed that the patient is 30 years of age or younger AND is on a Children's Oncology Group protocol, this test will be canceled and automatically reordered by the laboratory as COGMF / Acute Myeloid Leukemia (AML), Children's Oncology Group Enrollment Testing, FISH, Varies.

 

For testing paraffin-embedded tissue samples from patients with AML/myeloid sarcoma, order MSTF / Myeloid Sarcoma, FISH, Tissue.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


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

 

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



Specimen Required


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 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 in original tube. Do not aliquot.

 

Acceptable:

Specimen Type: 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 in original tube. Do not aliquot.


Reject Due To

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

Specimen Minimum Volume

Blood: 2 mL
Bone Marrow: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Refrigerated 

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Method Name

Fluorescence In Situ Hybridization (FISH)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

88271x2, 88275x1, 88291x1- FISH Probe, Analysis, Interpretation; 1 probe set

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

Reporting Name

AML, Specified FISH

Reference Values

An interpretive report will be provided.

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.

Secondary ID

614202

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all additional probe sets performed.

 

This is not intended as a panel test and the desired probes must be specified upon order. If the patient is being evaluated for known abnormalities, targeted probes must be listed in the probe request field. Reflex probes can be performed when appropriate only if specified in the order request field.

 

When specified, any of the following probes will be performed:

t(8;21), RUNX1T1::RUNX1

Reflex: t(3;21)(q26.2;q22) MECOM::RUNX1

t(15;17), PML::RARA

Reflex: 17q21 rearrangement, RARA break-apart

11q23 rearrangement, MLL (KMT2A)

Reflex: t(4;11)(q21;q23), AFF1::MLL

Reflex: t(6;11)(q27;q23), MLLT4(AFDN)::MLL

Reflex: t(9;11)(p22;q23), MLLT3::MLL

Reflex: t(10;11)(p13;q23), MLLT10::MLL

Reflex: t(11;16)(q23;p13.3), MLL::CREBBP

Reflex: t(11;19)(q23;p13.1), MLL::ELL

Reflex: t(11;19)(q23;p13.3), MLL::MLLT1

inv(16) or t(16;16), MYH11::CBFB

Reflex: 16q22 rearrangement, CBFB break-apart

inv(16), GLIS2::CBFA2T3

11p15.4 rearrangement, NUP98 break-apart

Reflex: t(7;11)(p15;p15.4), HOXA9::NUP98

12p13 rearrangement, ETV6 break-apart

Reflex: t(7;12)(q36;p13), MNX1::ETV6

t(6;9), DEK::NUP214

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

Reflex: t(1;3)(p36;q21), PRDM16::RPN1

Reflex: t(3;21)(q26.2;q22), MECOM::RUNX1

t(8;16), KAT6A::CREBBP

t(1;22), RBM15::MKL1

-5/5q-, D5S630/EGR1

-7/7q-, D7Z1/ D7S486

17p-, TP53/D17Z1

t(9;22), BCR::ABL1

Reflex: 9q34 rearrangement, ABL1 break-apart

 

Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.

 

For more information see:

Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up

Acute Leukemias of Ambiguous Lineage Testing Algorithm

Acute Myeloid Leukemia: Testing Algorithm

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
AMLMB Probe, Each Additional (AMLMF) No, (Bill Only) No

Forms

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

Sanford Laboratories - Sioux Falls/Rapid City Additional Information:

SANFORD LABORATORY INTERFACE BUILD INFORMATION:

 Result Code     Result Code Description   
 26683  Result Summary
 26684

 Interpretation

 26685  Result Table
 26686  Result
 26687

 Reason for Referral

 26689  Specimen
 26690  Source
 26691  Method
 26692  Additional Information
 26693  Disclaimer

 26694

 26688

 Released By

 Probes Requested