Test Overview
Test Methodology

Reverse transcription followed by Real-Time Polymerase Chain Reaction (PCR)

Test Usage

Greater than 95% of acute promyelocytic leukemia (APL) cases harbor a t(15;17) translocation. This rearrangement results in the fusion of the PML and retinoic acid receptor alpha (RARA) genes located on chromosomes 15 and 17 respectively. Three breakpoint regions within the PML gene can be involved, resulting in three possible PML/RARA fusion types: bcr1 (long), bcr2 (variable), and bcr3 (short). This test quantitatively detects all three PML/RARA transcript variants in peripheral blood and bone marrow. Testing for PML/RARA can assist in the diagnosis, clinical management, and monitoring of APL.

Reference Range *

Interpretive report provided.

Test Limitations

The limit of detection of this assay is 1/1,000 cells carrying the PML/RARA fusion. Mutations may not be detected in samples with a neoplastic burden below this level. This assay will not detect atypical rearrangements outside of the tested breakpoint regions or rearrangements involving uncommon RARA fusion partners such as NPM1, STAT5B, NUMA, PLZF. Specimens older than 48-72 hours may result in failed testing due to RNA degradation.

Test Details
Days Set Up
Monday - Friday
Analytic Time

2 - 7 days

Soft Order Code
QPML
MiChart Code
PML/RARA, Quantitative
Synonyms
  • PML-RARA
  • Promyelocytic Leukemia (APL)
Laboratory
Molecular Diagnostics
Section
Molecular Diagnostics
Specimen Requirements
Collection Instructions

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice.

Lavender Top Tube
Normal Volume
5 mL EDTA (lavender) whole blood; 3 mL EDTA (lavender) bone marrow; Fresh/frozen tissue and fresh aspirates or body fluids; Fresh/frozen cells in RPMI
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
81315
Fee Code
NA099
Pro Fee CPT
G0452-26
NY State Approved
No