BCR-ABL1 qualitative real-time PCR

Intended Use

Intended Use: BCR-ABL1 qualitative real-time PCR is intended for the qualitative detection and differentiation of BCR-ABL1 fusion gene transcripts (e13a2, e13a3, e14a2, e14a3, e1a2, e1a3, e19a2, e19a3, e6a2, e6a3, e8a2 and e8a3) using real time PCR system. It is appropriate for initial diagnosis of chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). 

Specimen Required

Whole blood or Bone marrow in lavender (EDTA).

Patient Preparation
  • Sample Collection: 2 Tubes / EDTA Blood / 2 mL per tube or bone marrow in lavender (EDTA).
  • Specimen Preparation

   Whole Blood: Do not freeze. Transport 5 mL whole blood. (Min: 1 mL)

   Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)

  • Storage/Transport Temperature: Refrigerated
  • Unacceptable Conditions
    • Plasma, serum, FFPE tissue blocks/slides, or frozen tissue.
    • Specimens collected in anticoagulants other than EDTA.
    • Clotted or grossly haemolyzed specimens.
  • Remarks: –
  • Stability:
    • Whole Blood: Ambient: 24 hrs; Refrigerated: 6 days; Frozen: 6 months
    • Bone Marrow: Ambient: 1 week; Refrigerated: 1 week; Frozen: 1 week
Methodology

This test uses real-time qualitative real time PCR to detect and identify the BCR-ABL1 and the ABL1 transcript.

Sample Received to Report Turnaround Time (TAT)

Twice in a week (Scheduled Test)

Reference Interval

Interpretive Data

Refer to report.

Resources

Sample Reports