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).
Whole blood or Bone marrow in lavender (EDTA).
- 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
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)
–
Interpretive Data
Refer to report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report
