Molecular Pathology Laboratory Network

PML/RARA Quantitative PCR Initial Diagnostic Workup

Test Code
P PML RARA
Test Synonyms
PML RARA t(15;17) short form, PML RARA t(15;17) long form
Associations
Acute promyelocytic leukemia (APL), FAB M3
Methodology
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) for
PML/RARA t(15;17) long form and PML/RARA t(15;17) short form
CPT Codes
83891 – Molecular isolation
83913 - RNA stabilization
83896 x2 – Nucleic acid probe each
83898 x3 – Amplification of patient nucleic acid, per primer pair
83902 x3 Reverse transcriptase
83912-26 – Interpretation and report
Turnaround Time
3-5 days (specimens accepted Monday through 1 p.m. on Friday. Assay run once/week
Specimen Requirements
  • 20.0 mL (min. 10.0 mL) peripheral blood in EDTA
  • 2.0 mL (min. 1.0 mL) bone marrow in EDTA
Specimen Stability
  • Stable at 2-8°C
  • Specimen must be received by MPLN within 48 hours of collection.
Storage & Handling
  • Ship peripheral blood and bone marrow at ambient temperature (Do not ship on ice or cold pack)
  • Please call before shipping on Friday for weekend delivery
Causes for Rejection
Specimen >48 hours old; Specimen clotted; Stored or shipped at incorrect temperature; Incorrect anticoagulant; Insufficient specimen volume
Reference Range
Positive: PML/RARA short or long fusion detected and quantified
Negative: PML/RARA short or long fusion not detected (0.002% PML/RARA)
Description
Utilized for the determination of baseline PML/RARA fusion gene transcript levels in patients with AML-M3 (APL) after induction and consolidation therapy.
References
  1. Gabert J et al. (2003). Standardization and quality control studies of real time quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual detection in leukemia-A Europe against cancer program. Leukemia. 17:2318-2357.
  2. Reiter et al. (2004). Pathogenesis, diagnosis and monitoring of residual disease in acute promyelocytic leukaemia. Acta Haematologica. 112:55
  3. Sanz MA. (2006). Treatment of acute promyelocytic leukemia. Hematology. 147-155.

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