Intended Use
RARA is a nuclear hormone receptor which forms heterodimers with the retinoid X receptor alpha and is involved in the regulation of promyelocyte differentiation. RARA fusion genes interfere with myeloid differentiation and contribute to the development of APL. The majority of APL patients are responsive to therapeutic doses of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) associated with chemotherapeutic drug regimen. Patients with ZBTB16-RARA or STAT5B-RARA fusions are resistant to ATRA and ATO. The FISH break apart assay is a valuable tool for the detection of RARA rearrangements independent of the translocation partner.
Patient Preparation
- Sample collection: Non-diluted bone marrow aspirate. Collect in a sodium heparinized Vacutainer.
- Specimen preparation: Do not freeze or expose to extreme temperatures.
- Bone Marrow: Transfer 3 mL bone marrow to a Green (Sodium Heparin). (Min: 1 mL)
- Whole Blood: Transport 5 mL whole blood. (Min: 2 mL)
- Storage/Transport Temperature: Room temperature.
- Unacceptable Conditions: Frozen specimens. Clotted specimens.
- Remarks:
- Stability: Ambient: 48 hours; Refrigerated: 48 hours; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Sample received to report Turnaround time (TAT)
3 working days
Reference Interval
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Interpretive Data
The most recent WHO classification of Tumours of Hematopoietic and Lymphoid Tissues (Revised 5th edition) is used for interpretation criteria for evaluation.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report