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IgVH Mutational Status

Test ID: M IgVH CPT Code: 81263
Expected Turnaround Time
14 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
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.
Requisition Forms
Oncology Pathology Requisition

Specimen Requirements

Specimen Requirements
  • Whole Blood: 5mL (minimum, 3mL), EDTA preferred (NaHep accepted)
  • Bone Marrow Aspirate: 3mL (minimum 1mL), EDTA preferred (NaHep accepted)
  • Refrigerated Extracted DNA: 50 µl at 50 ng/µl
  • Frozen Extracted DNA: 50 µl at 50 ng/µl
Specimen Stability
  • Whole Blood: 30 days
  • Bone Marrow Aspirate: 30 days
  • Refrigerated Extracted DNA: 60 days
  • Frozen Extracted DNA: Long Term
Storage Requirements
  • Whole Blood: 2°C to 8°C
  • Bone Marrow Aspirate: 2°C to 8°C
  • Fresh Tissue: 2°C to 8°C
  • Refrigerated Extracted DNA: 2°C to 8°C
  • Frozen Extracted DNA: ≤ -15°C
Shipping Recommendations
  • Whole Blood: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Bone Marrow Aspirate: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Refrigerated Extracted DNA: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Frozen Extracted DNA: FROZEN, Ship samples on dry ice. Separate dry ice from specimens. 
Specimen Rejection Criteria

Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimens beyond stability; Insufficient DNA isolated

Test Details

Keywords
Molecular Diagnostics, Oncology, Chronic Lymphocytic Leukemia (CLL), Mutation Analysis, DNA Sequencing, Genomics, Next Generation Sequencing
Test Method
Next Generation Sequencing (NGS)
Methodology Category
Molecular
Regulatory Status
RUO
Special Considerations
  • 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.
Associations

Chronic Lymphocytic Leukemia, CLL / SLL