Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetic studies on the test request form. Note: This test number is used for tracking FISH specimens to the testing laboratory. Bill codes will be added when testing is complete based on the processes performed in the laboratory.
Expected 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.
Specimen Requirements
Specimen
Blood, bone marrow, CSF, fixed-cell pellet from a cytogenetic analysis, two slides with metaphase and/or interphase nuclei.
Volume
10 mL blood (adult), 5 mL blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, or four slides with metaphase and/or interphase nuclei.
Minimum Volume
5 mL blood (adult), 1 mL blood (pediatric), 1 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, or one slide with metaphase and/or interphase nuclei. Note: minimum slide volumes may not allow for repeat testing.
Container
Green-top (heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube
Collection
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.
Storage Instructions
Room temperature
Causes for Rejection
Broken Vacutainer®; broken slides; stained slides; paraffin blocks; paraffin slides; decalcified bone cores; frozen specimen; quantity not sufficient for analysis
Test Details
Use
Fluorescence in situ hybridization (FISH), acute myelocytic leukemia (AML), and PML/RARA
Limitations
Molecular mutations below the resolution of FISH will not be detected. Will not detect regions not targeted by FISH probes in this panel.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).
Methodology
Fluorescence in situ hybridization (FISH)
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 511834 | PML/RARA FISH Panel | 511835 | CELS Counted | 62361-1 | ||
| 511834 | PML/RARA FISH Panel | 511836 | CELS Analyzed | 62360-3 | ||
| 511834 | PML/RARA FISH Panel | 511837 | FISH Result | 48674-6 | ||
| 511834 | PML/RARA FISH Panel | 511838 | Interpretation | 77031-3 | ||
| 511834 | PML/RARA FISH Panel | 511839 | Specimen Type | 31208-2 | ||
| 511834 | PML/RARA FISH Panel | 511840 | Director Review | 48672-0 |
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CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf