510336: Acute Myelocytic Leukemia (AML) Profile, FISH

Test Details

Methodology

Fluorescence in situ hybridization (FISH)

Result Turnaround Time

3 - 5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Oncology Fluorescence in situ Hybridization (FISH)

Test Includes

FISH for acute myelocytic leukemia (AML), targeting rearrangement of PML-RARA, CBFB, RUNX1/RUNX1T1, KMT2A and numerical changes of 5q, and 7q

Use

This test is a diagnostic and prognostic test for acute myeloid leukemia; detection rate is 80% of the known chromosome causes of AML.

Diagnostic and prognostic test for acute myeloid leukemia; detection rate is 80% of the known chromosome causes of AML.

This test is a diagnostic and prognostic test for acute myeloid leukemia; detection rate is 80% of the known chromosome causes of AML.

Special Instructions

Indicate pertinent clinical diagnosis and previous cytogenetic studies on the test request form.

Limitations

Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Molecular mutations or chromosomal alterations not targeted by the probe~~s included in this profile will not be detected~~.

Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Specimen Requirements

Specimen

Whole blood, bone marrow, CSF, fixed-cell pellet from a cytogenetic analysis, slide with metaphase and/or interphase nuclei or bone marrow touch preparation slides are acceptable for testing.

~~Blood, bone marrow, fixed-cell pellet from a cytogenetic analysis, or slides prepared from a cytogenetic analysis~~

Whole blood, bone marrow, CSF, fixed-cell pellet from a cytogenetic analysis, slide with metaphase and/or interphase nuclei or bone marrow touch preparation slides are acceptable for testing.

Volume

5 mL whole blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, 12 slides with metaphase and/or interphase nuclei or 12 touch preparation slides

~~10 mL blood (adult), 3 to 5 mL blood (pediatric), 1 to 3 mL bone marrow, one tube fixed-cell pellet, or te~~n slides

5 mL whole blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, 12 slides with metaphase and/or interphase nuclei or 12 touch preparation slides

Minimum Volume

1 mL whole blood (pediatric), 1 mL bone marrow, fixed-cell pellet from cytogenetic analysis, 6 slides with metaphase and/or interphase nuclei or 6 touch preparation slides (Note: Minimum volumes may not allow for repeat testing.)

1 mL ~~blood (adult/pediatric), 1 mL bone marrow, or six slides~~

Container

Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). For samples with shared karyotype (510999) and any FISH study in the same tube, EDTA is not recommended due to the growth inhibition in cell culture. Adjust tube size to sample volume to avoid heparin toxicity.

Green-top (~~heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube~~

Collection Instructions

Utilize sterile technique and Labcorp transport kits when possible.

Storage Instructions

Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze.

~~Maintain specimen at room temperatur~~e.

Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze.

Causes for Rejection

Broken Vacutainer®; broken or stained slides; decalcified bone core; frozen specimen; quantity not sufficient for analysis

Broken Vacutainer®; broken or ~~dirty slides; excessive cellular debris or stained slides; frozen specimen; decalcified tissue~~