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PML RARA t(15;17) - Quantitative by PCR

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Report in 240Hrs

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No Fasting Required

Details

Detects fusion transcript.

₹6,956₹9,937

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PML RARA t(15;17) - Quantitative by PCR

  • Why is it done?
    • Detects and quantifies the PML-RARA fusion gene resulting from the t(15;17) chromosomal translocation using quantitative polymerase chain reaction (qPCR) technology
    • Diagnoses acute promyelocytic leukemia (APL), a subtype of acute myeloid leukemia (AML) characterized by the pathognomonic t(15;17) translocation
    • Monitors minimal residual disease (MRD) during and after treatment with arsenic trioxide and all-trans retinoic acid (ATRA)
    • Provides prognostic information and guides therapeutic decisions in APL management
    • Detects disease relapse early, allowing for timely intervention and salvage therapy
    • Performed at diagnosis to confirm APL classification and at regular intervals during remission to assess treatment response
  • Normal Range
    • Negative Result: PML-RARA fusion gene not detected or below detection limit (typically <0.01% to 0.001% depending on laboratory sensitivity)
    • Units of Measurement: Copy number per microgram of RNA, percentage (%), or as a ratio normalized to internal control genes
    • Detection Threshold: Most sensitive assays can detect PML-RARA at levels as low as 0.001% (1 leukemic cell in 100,000 normal cells)
    • Normal Interpretation: Absence of detectable PML-RARA indicates no evidence of APL or achievement of molecular remission in treated patients
  • Interpretation
    • Positive Result at Diagnosis: Confirms APL diagnosis. High initial PML-RARA levels (>10^3 to 10^4 copies) may indicate higher disease burden and higher risk of early hemorrhagic complications and disseminated intravascular coagulation (DIC)
    • Decreasing Levels During Treatment: Indicates good therapeutic response to ATRA and arsenic trioxide. Progressive decline of >1 log (90% reduction) per assessment interval suggests effective disease control
    • Molecular Remission: Undetectable PML-RARA after initial treatment indicates complete molecular response and is associated with favorable long-term prognosis
    • Rising or Persistent Levels: Suggests treatment resistance or emerging drug-resistant clones. May necessitate treatment modification or escalation
    • Detection of MRD During Remission: Detectable PML-RARA (typically >0.1%) predicts relapse within 6-12 months and warrants consideration for intensified consolidation therapy or maintenance therapy
    • Quantitative Burden as Prognostic Factor: Initial PML-RARA transcript levels correlate with white blood cell count, cytogenetic complexity, and predict event-free survival. Higher initial loads associated with worse prognosis if untreated
    • Factors Affecting Results: Specimen type (bone marrow vs peripheral blood), RNA quality, timing of specimen collection relative to therapy, presence of interfering substances, and laboratory methodology can impact quantitation accuracy
  • Associated Organs
    • Primary Organ System: Bone marrow (primary site of malignant transformation) and blood (site of leukemic cell circulation)
    • Acute Promyelocytic Leukemia (APL): The pathognomonic disease for this test. Arises from malignant transformation of promyelocytes with t(15;17) translocation fusing PML and RARA genes
    • Hematologic Complications: Severe coagulopathy, disseminated intravascular coagulation (DIC), hemorrhage, thrombocytopenia, and anemia frequently accompany APL
    • Hemorrhagic Manifestations: Can occur in brain, lungs, gastrointestinal tract, and other organs. APL accounts for significant early mortality related to hemorrhage
    • Central Nervous System: CNS leukostasis and intracerebral hemorrhage represent serious complications; CNS prophylaxis considered in high-risk patients
    • Secondary Organ Involvement: Hepatosplenomegaly, lymphadenopathy, and extramedullary leukostasis can affect multiple organs in advanced disease
  • Follow-up Tests
    • Repeat PML-RARA PCR Testing: Performed at defined intervals: post-induction therapy completion, after consolidation cycles, and at months 3, 6, 12 months during maintenance therapy, then every 3-6 months during remission
    • Complete Blood Count (CBC): Monitors leukocyte, platelet, and hemoglobin levels; assesses hematologic toxicity from therapy and development of cytopenias
    • Coagulation Panel (PT, INR, aPTT, Fibrinogen): Essential at diagnosis and during early treatment to monitor for DIC and coagulopathy resolution
    • Peripheral Blood Smear: Confirms morphologic remission and assesses blast clearance during and after treatment
    • Bone Marrow Aspiration and Biopsy: Performed at diagnosis for morphology, cytochemistry, and cytogenetics; repeated at end of induction to assess morphologic complete remission
    • Cytogenetics and FISH (Fluorescence In Situ Hybridization): Confirms t(15;17) translocation at diagnosis; rapid FISH technique used in urgent settings for quick confirmation
    • Flow Cytometry: Provides immunophenotypic characterization of leukemic population and aids in MRD detection by flow cytometry, which can complement PCR-based MRD assessment
    • Chemistry Panel (LDH, Creatinine, Liver Enzymes): Monitors organ function, assesses disease burden (elevated LDH), and detects drug-induced hepatotoxicity or nephrotoxicity
    • PML-RARA Breakpoint Analysis: Identifies short (S), long (L), or variable (V) breakpoint forms, which correlates with prognosis and can guide assay design for optimal MRD monitoring
  • Fasting Required?
    • Fasting: No
    • Patient Preparation: No special fasting or dietary requirements. Patient should inform phlebotomist of current medications, though no medications typically need to be held
    • Specimen Type and Collection: Bone marrow aspirate (preferred for diagnostic sample) or peripheral blood collected in EDTA (lavender-top) tube; blood samples must be processed promptly to preserve RNA integrity
    • Specimen Handling: Samples should be processed within 4-24 hours of collection. Some laboratories accept samples stored at room temperature; others require refrigeration at 2-8°C. Follow specific laboratory instructions regarding transport and storage
    • Medications and Supplements: Continue all current medications including ATRA, arsenic trioxide, and other chemotherapy agents as prescribed. Medications do not interfere with test accuracy
    • Timing Considerations: For MRD monitoring, consistent timing relative to therapy cycles (e.g., day 1 or day 15 of each cycle) improves comparability of results and trend interpretation

How our test process works!

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