ARUP's Laboratory Test Directory

0056100: PML/RARa t(15;17) Translocation by RT-PCR

Test Mnemonic: PML
Methodology: Reverse Transcription Polymerase Chain Reaction

Performed: RNA isolation: Sun-Sat; Assay: Varies

Reported: 2-7 days

Specimen Required:  
Collect: One 5 mL lavender (EDTA), pink (K2EDTA), yellow (ACD Solution A), green (sodium or lithium heparin), lt. blue (sodium citrate), or 3 mL bone marrow.

Transport: 5 mL whole blood or 3 mL bone marrow (EDTA) at 2-8°C.

Pediatric Collection/Transport: 1 mL whole blood (lavender, EDTA) or 1 mL bone marrow (EDTA) at 2-8°C.

Remarks: Samples must be received within 48 hours of collection due to lability of RNA.

Stability: Ambient: 1 hour; Refrigerated: 2 days; Frozen: Unacceptable

Reference Interval:
Negative: PML/RARa fusion transcript is not detected.
Positive: PML/RARa fusion transcript is detected.

Interpretive Data:
By report

Please refer to Statement B in the Compliance Statements section in the front of the Laboratory Test Directory.



Note:
A positive result indicates the presence of a PML/RARa fusion transcript.  A negative result indicates the absence of a PML/RARa fusion transcript within the sample. 
The t(15;17) chromosomal translocation which leads to the PML/RARa fusion transcript is strongly associated with acute promyelocytic leukemia (APL).  The detection of this highly characteristic abnormality is useful in the accurate diagnosis of APL.  These tumor-specific markers can also be used to monitor the remission status of affected patients.  RT-PCR provides a rapid alternative to cytogenetic analysis and may identify PML/RARa gene rearrangement in the absence of detectable t(15;17) by the latter technique.

This test is not intended for minimal residual disease detection.  Results of this test must always be interpreted in the context of morphologic and other relevant data, and should not be used alone for a diagnosis of malignancy.

CPT Code(s):
83891 Isolation; 83902 Reverse transcription; 83913 RNA stabilization; 83898 x2 Amplification; 83896 x4 Nucleic acid probes; 83912 Interpretation and report - Additional CPT code modifiers may be required for procedures performed to test for oncologic or inherited disorders.