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Test Name:
IgVH Mutation Analysis, by Sequencing


  • SBMF No:
    44749
  • Performance Lab Name:
    ARUP Laboratories
  • Test Mnemonic:
    IGVH MUT
  • ABN:
    Required – Not FDA-Approved
  • CPT Code:
    83891; 83894; 83898x5; 83902; 83912
    If indicated, add: 83892; 83904; 83909
  • LOINC Code:
    48670-4
  • Ref Lab Test No:
    0040227
  • Also Known As:
    IgVH Somatic Hypermutation
  • Spec Type:
    Whole blood
  • Spec Container:
    Lavender top (EDTA) tube
  • Alt Spec Type:
    Bone marrow
  • Alt Spec Container:
    Lavender top (EDTA) tube
  • Pref Vol:
    Whole blood: 5.0 mL
    Bone marrow: 3.0 mL
  • Min Vol:
    1.0 mL
  • Fasting:
    No
  • Spec Collect:
    Whole blood: Routine venipuncture
    Bone marrow: Collected by physician
  • Spec Process:
    Gently invert tube to mix
    Do not centrifuge
    Do not remove plasma from cells
    Specimen cannot be frozen
  • Spec Store Transport:
    Refrigerated
    Samples must be received at ARUP within 48 hours of collection due to lability of RNA
  • Spec Stability:
    1 hour room temperature (20-30°C)
    48 hours refrigerated (2-8°C)
    Frozen (-20°C): Unacceptable
  • Spec Reject:
    Serum or plasma sample
    Frozen or clotted whole blood or bone marrow sample
    Sample collected in preservative other than EDTA
    Severely hemolyzed sample
  • Methodology:
    Polymerase Chain Reaction (PCR)
    Sequencing
  • Clinical Significance:
    Refer to:
    ARUP Consult | The Physician's Guide to Laboratory Test Selection and Interpretation
  • Reference Range:

    By report

    Note:
    This assay is designed for individuals with a confirmed diagnosis of CLL, and for these individuals testing will include sequencing. All other diagnoses will terminate after amplification and will not have the sequencing component.

  • Additional Test Info:
    This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
  • Day Run:
    Varies
  • Time Reported:
    13-15 days
  • Test Type:
    GENETIC