PML::RARA Translocation t(15;17) by Real-time PCR
CPT Code(s)
81315; G0452
Synonym(s)
Hematopathology, RNA, PCR, PML::RARA, PML-RARA, Acute promyelocytic leukemia, APL, AML, acute myeloid leukemia
Performed
Molecular Diagnostics Laboratory
Clinical Indication and Relevance
The assay can confirm the initial diagnosis of acute promyelocytic leukemia (APL) carrying the PML::RARA t(15;17) translocation. It can also be used to monitor minimal residual disease.
Methodology
RNA is isolated from peripheral blood or bone marrow and reverse transcribed. Real-time PCR is performed using specific primers amplifying PML::RARA fusion transcripts. Results are reported as positive or negative for PML::RARA fusion transcripts.
Minimum Specimen Requirements
Collect
- Peripheral blood (PB): 3-5 mL, in purple top (EDTA) tube
- Bone marrow (BM): 1-3 mL, in purple top tube
Transport Deliver immediately at 2-8°C (wet ice or cold packs). Do not freeze.
Stability Ambient – 1 hour; refrigerated – 48 hours. Note: for RNA based assays, samples should be transported to the laboratory within 8 hours of collection (optimal), or up to a maximum of 48 hours after collection to avoid RNA degradation. RNA integrity is critical, especially for samples used for monitoring minimal residual disease.
Unacceptable Samples Serum or plasma; frozen PB or BM; clotted blood; severely hemolyzed samples.
Turnaround time
- 24-48 hours for initial diagnosis case
- Five to seven working days for follow-up samples