IgVH Mutational Status
Use
This assay determines IgVH somatic hypermutation (SHM) status in CLL/SLL patients which is a primary component for disease risk stratification. Un-mutated IgVH has been established as a strong and independent predictor of adverse clinical prognosis and reduced overall survival.
Special Instructions
Frozen blood and bone marrow samples are NOT accepted. Extracted DNA: Isolation of nucleic acids for clinical testing must occur in a CLIA-certified laboratory or a laboratory meeting equivalent requirements. Concentration and volume must be provided for all samples.
Limitations
The assay's results are intended for clinical use only and may be subject to change based on biopharmaceutical protocol requirements. It is crucial for such tests to be conducted in certified laboratories meeting CLIA or equivalent requirements to ensure the reliability of nucleic acid isolation and other processes involved.
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5mL
Minimum Volume
3mL
Container
EDTA preferred (NaHep accepted)
Storage Instructions
2°C to 8°C
Causes for Rejection
Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimens beyond stability; Insufficient DNA isolated
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 30 days |
| Frozen | Long Term |