PML-RARA t(15;17), Quantitative Real-Time PCR
Test Summary
This assay detects the short form (bcr3), long form (bcr1) and the variant exon 6 (bcr2) PML-RARA transcripts associated with the t(15; 17) chromosomal translocation. PML-RARA transcript levels are expressed as normalized copy number (NCN) of PML-RARA using ABL1 as internal control. The lower limit of PML-RARA + leukemia detection in this assay is dependent on the quality of RNA obtained and the cellularity of the sample. Analytic assay sensitivity is determined at 1:100,000.
Various clinical regimens combining all-trans retinoic acid (ATRA), arsenic trioxide (ATO) and anthracyclines now cure the majority of APL patients. ATRA induces APL differentiation and transient remissions. ATO targets PML through oxidation-triggered disulphide bond formation and direct binding, resulting in PML-RARA sumoylation, ubiquitylation and proteasome-mediated degradation (Lallemand-Breitenbach et al. 2012).
Aliases
- N/A
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Do not reject specimens, send to laboratory for screening.
Collect 5 mL of whole blood or 3 mL bone marrow in an EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information.
If the stability of the sample cannot be determined, delay in result or cancelation of test may occur. Clotted specimens are unacceptable.
Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.
Patient Preparation
Storage
Transport Temperature
Extracted RNA: Refrigerated (cold packs)
Specimen Stability
- Whole blood and Bone marrow
- Room temperature: 5 days
- Refrigerated: 5 days
- Frozen: Unacceptable
- Extracted RNA
- Room temperature: Unacceptable
- Refrigerated: Preferred
- Frozen: Acceptable
Limitations
Other Acceptable Specimens
Unacceptable Specimens
Order Code
EPIC (Premier) Code
Includes
CPT Code
- 81315
Billing Code
- 670854
CPT Statement
Methodology
FDA Status
Physician Attestation of Informed Consent
Testing Laboratory
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Range
Setup Schedule / Expected Turnaround Time
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Do not reject specimens, send to laboratory for screening.
Collect 5 mL of whole blood or 3 mL bone marrow in an EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information.
If the stability of the sample cannot be determined, delay in result or cancelation of test may occur. Clotted specimens are unacceptable.
Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.
Patient Preparation
Storage
Transport Temperature
Extracted RNA: Refrigerated (cold packs)
Specimen Stability
- Whole blood and Bone marrow
- Room temperature: 5 days
- Refrigerated: 5 days
- Frozen: Unacceptable
- Extracted RNA
- Room temperature: Unacceptable
- Refrigerated: Preferred
- Frozen: Acceptable