PML-RARA Translocation by FISH
Also known as: FISH PML
Use
This test is a rapid confirmatory diagnostic test for acute promyelocytic leukemia (APL). The presence of the PML::RARA fusion due to translocation (15;17)(q24;q21) is consistent with the diagnosis of APL. It is performed using fluorescence in situ hybridization (FISH), which identifies and visualizes the specific chromosomal translocation associated with the condition, assisting in the proper diagnosis and treatment planning for patients suspected of having APL.
Special Instructions
Not provided.
Limitations
Frozen, paraffin-embedded, or clotted specimens are unacceptable. The test has not been cleared or approved by the FDA. It was developed and its performance characteristics determined by ARUP Laboratories, a CLIA-certified laboratory. Results and interpretations are intended for clinical use, but there is a potential for delay in culturing and reporting if clinical indication or specimen type are unavailable at the onset. Stability constraints exists at 48 hours for ambient and refrigerated conditions, beyond which specimen validity may decline.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
PRAM1-PRAM1 fusion
Fusion
LOINC Codes
- 57802-1 - Chrom analy interphase Bld/Mar FISH-Imp
- 11526-1 - Pathology study
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Bone Marrow
Volume
3 mL
Minimum Volume
1 mL
Container
Green (sodium heparin) tube or heparinized syringe
Collection Instructions
Nondiluted bone marrow collected in a heparinized syringe or transferred to a green (sodium heparin) tube.
Storage Instructions
Room temperature
Causes for Rejection
Frozen specimens, paraffin-embedded specimens, clotted specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48 hours |
| Refrigerated | 48 hours |
| Frozen | Unacceptable |
Other tests from different labs that may be relevant