PML-RARA, Qualitative with Reflex to HemaVision

Specimen Collection, Storage, and Shipping

Test Information:

The test uses reverse transcription and PCR to detect the t(15;17)(q24.1;q21.2) PML-RARA fusion transcript that is the defining translocation in acute promyelocytic leukemia (APL), a subtype of acute myeloid leukemia (AML). Detection of t(15;17) may be used to confirm clinically-suspected APL based on a patient’s clinical presentation and/or morphology and justify continued treatment with all-trans retinoic acid (ATRA).

The assay is highly specific for the L, bcr1; V, bcr2; and S, bcr3 breakpoint isoforms of the t(15;17) translocation. Differential splicing or rearrangements, or natural polymorphisms for a particular patient can impact the assay result.

If the sample is negative for t(15;17)(q24.1;q21.2) PML-RARA, the full Hemavision panel will be tested. The full Hemavision panel includes alternate APL translocations t(11;17)(q23.2;q21.2) ZBTB16-RARA and t(5;17)(q35.1;q21.2) NPM1-RARA as well as other translocations present in AML. Please see HemaVision Leukemia Panel for test details.

Should APL be suspected, ATRA should be initiated immediately with supportive measures and genetic testing ordered.

Requisition Code:

PML-RARA, Qualitative with Reflex to HemaVision

CPT Code:

81315; G0452-26

Turn Around Time:

2-3 business days

Specimen Requirements:

Collect:           Peripheral blood: 2-5 mL in EDTA (purple top) tube

                        Bone marrow: 2-5 mL in ACD (yellow) or EDTA (purple) tube

Storage:         Refrigerate

Remarks:       Specimens must be received within 72 hours from collection due to instability of RNA. WBCC is required to accompany specimen.

Transport:      See Standard Shipping Procedure

References:
  1. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544.
  2. Blood Cancer Journal (2015) 5, e304 (2015) doi:10.1038/bcj.2015.25
  3. Arch Pathol Lab Med. 2015 Oct;139(10):1308-13. doi: 10.5858/arpa.2013-0345-RS.