Intended Use
BRAF V600 qualitative real-time PCR is an in vitro diagnostic test intended for the qualitative detection of BRAF V600 codon somatic mutations in the genomic DNA using Real Time 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/Plasma: 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 PCR (ARMS) to detect and identify the BRAF V600 based on allele specific amplification.
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
