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BCR-ABL Qualitative - EDTA Whole Blood

Genetic
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Report in 120Hrs

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nofastingrequire

No Fasting Required

Details

Detects presence of BCR-ABL fusion gene.

₹4,958₹7,083

30% OFF

BCR-ABL Qualitative - EDTA Whole Blood

  • Why is it done?
    • Detects the presence of the BCR-ABL fusion gene through qualitative reverse transcription polymerase chain reaction (RT-PCR) in whole blood samples
    • Initial diagnosis of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with t(9;22) chromosomal translocation
    • Confirmation of BCR-ABL status when cytogenetic testing or FISH results are inconclusive or unavailable
    • Monitoring disease status during treatment with tyrosine kinase inhibitors (TKIs)
    • Assessment of minimal residual disease (MRD) and detection of treatment response or relapse
    • Typically performed at initial diagnosis, during follow-up appointments (every 3-6 months), and when clinical changes suggest disease progression or response
  • Normal Range
    • Normal Result: Negative or Not Detected - absence of BCR-ABL fusion gene
    • Abnormal Result: Positive or Detected - presence of BCR-ABL fusion gene transcripts
    • Units: Qualitative (Present/Absent) or Semi-quantitative (measured in copies/mL or International Scale IS%)
    • Interpretation: Negative results indicate absence of BCR-ABL gene, ruling out CML or BCR-ABL+ ALL. Positive results confirm the presence of the Philadelphia chromosome or its molecular equivalent and warrant further investigation and treatment initiation.
  • Interpretation
    • Positive BCR-ABL Result: Confirms BCR-ABL fusion gene presence, diagnostic of CML (any phase) or BCR-ABL+ ALL; requires immediate treatment initiation with tyrosine kinase inhibitors; indicates need for additional cytogenetic and molecular studies to determine BCR-ABL transcript type (p210, p190, or p230) and establish baseline quantitative PCR levels
    • Negative BCR-ABL Result: Excludes BCR-ABL+ leukemia; may indicate CML in complete molecular remission if patient is under treatment; in untreated patients, suggests diagnosis other than BCR-ABL+ disease; requires correlation with complete blood count, peripheral blood smear, and bone marrow aspirate findings
    • Factors Affecting Results: Sample quality and proper EDTA collection, timing of phlebotomy (some diurnal variation possible), presence of mutations affecting primer binding sites, specimen transportation time and temperature, leukocyte count variations, interference from contamination, and treatment status of patient
    • Clinical Significance: BCR-ABL positive results are pathognomonic for CML and some ALL cases; negative results in treated patients may indicate achievement of major molecular response (MMR) or complete molecular response (CMR); serial monitoring provides critical information for treatment optimization and early detection of resistance or relapse
  • Associated Organs
    • Primary Organ System: Bone marrow and hematopoietic system; circulating blood and lymphoid tissues
    • Diseases Associated with Positive Results: Chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase; BCR-ABL positive acute lymphoblastic leukemia (ALL); atypical CML; Ph-like ALL; rare cases of acute myeloid leukemia (AML)
    • Secondary Organ Involvement: Spleen (splenomegaly common), liver (hepatomegaly possible), lymph nodes (enlargement), central nervous system (in advanced disease), bones (hyperuricemia-related complications)
    • Potential Complications: Leukostasis, bleeding complications from thrombocytopenia, infection from leukopenia, hyperuricemia and tumor lysis syndrome, organ infiltration in blast crisis, secondary malignancies from treatment, thrombotic events, and development of tyrosine kinase inhibitor resistance
  • Follow-up Tests
    • Additional Tests for Positive Results: BCR-ABL quantitative real-time PCR (International Scale), bone marrow aspirate and biopsy for cytogenetics and morphology, conventional karyotype analysis, fluorescence in situ hybridization (FISH), complete blood count (CBC) with differential, comprehensive metabolic panel, uric acid, lactate dehydrogenase (LDH), and phosphorus
    • Monitoring During Treatment: BCR-ABL quantitative PCR at 3, 6, and 12 months, then every 6-12 months; frequency increases with disease progression or inadequate response; baseline and periodic mutation analysis if BCR-ABL resistance develops
    • Complementary Tests: BCR-ABL transcript type determination, point mutation detection (for TKI resistance), white blood cell count trends, platelet and hemoglobin levels, coagulation studies if indicated, and imaging (ultrasound or CT) for organ assessment
    • Recommended Monitoring Frequency: Newly diagnosed: every 1-3 months until stable response achieved; stable responders: every 6-12 months; patients with rising transcript levels or resistance: monthly or as clinically indicated
    • Additional Investigations: Blast count evaluation, Philadelphia chromosome confirmation, assessment of BCR-ABL protein expression, and evaluation for BCR-ABL kinase domain mutations if TKI resistance suspected
  • Fasting Required?
    • Fasting Requirement: No - fasting is not required for BCR-ABL qualitative testing
    • Sample Collection Requirements: Peripheral venous blood collected in EDTA (ethylenediaminetetraacetic acid) tube (purple top/lavender top); minimum volume typically 3-5 mL; proper tube inversion 8-10 times to ensure adequate mixing of anticoagulant
    • Patient Preparation Instructions: No special preparation needed; patient may eat and drink normally; may take medications as prescribed; inform phlebotomist of current medications and treatment status; timing of collection should be consistent if serial monitoring performed (preferably morning draws)
    • Specimen Handling: Keep specimen at room temperature (18-25°C) if processing within 24 hours; do not freeze or refrigerate EDTA whole blood samples; transport promptly to laboratory (ideally within 6 hours of collection); maintain tube integrity and proper labeling
    • Medications: No medications need to be withheld; continue all prescribed medications including tyrosine kinase inhibitors as directed; anticoagulants (warfarin, direct oral anticoagulants) do not interfere with test; timing of TKI administration should be noted on requisition form
    • Additional Considerations: Inform laboratory of treatment status and current TKI therapy; note any recent infections or illnesses; document any prior BCR-ABL results for comparison; ensure proper patient identification to avoid specimen mix-up; contact laboratory if specimen cannot be processed within required timeframe

How our test process works!

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