Intended Use
FLT3 ITD/TKD qualitative real-time PCR based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutation (D835/I836) in the FLT3 gene in genomic DNA using combination of Real Time PCR and conventional PCR.
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 assay utilizes the combination of conventional and real-time PCR to detect and identify the TKD and ITD mutations.
Sample Received to Report Turnaround Time (TAT)
Twice in a week (Scheduled Test)
Reference Interval
–
Interpretive Data
Refer to report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report