PML::RARA Translocation t(15;17) by Real-time PCR

CPT Code(s)

81315; G0452


Hematopathology, RNA, PCR, PML::RARA, PML-RARA, Acute promyelocytic leukemia, APL, AML, acute myeloid leukemia


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.


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


  • 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
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