Ordering Recommendation

Determine risk group in newly diagnosed CLL.

Mnemonic
IGHV MUT
Methodology

Polymerase Chain Reaction/Sequencing

Performed

Varies

Reported

8-12 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA) or bone marrow (EDTA). Also acceptable: RNA extracted by CLIA certified lab.

Specimen Preparation

Whole Blood: Transport 5 mL whole blood. (Min: 1 mL)
Bone Marrow:
Transport 3 mL bone marrow. (Min: 1 mL)
Specimens must be received within 48 hours of collection due to lability of RNA.
Extracted RNA:
Transport 40uL RNA with at least 40 ng/uL concentration (Min: 40uL). Transport RNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Whole Blood or Bone Marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.
Extracted RNA: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.

Unacceptable Conditions

Serum, plasma, CSF, extracted DNA, RNA extracted by a non-CLIA lab, bone core, or FFPE tissue. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.

Remarks
Stability

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
Extracted RNA: Ambient: Unacceptable; Refrigerate: Unacceptable; Frozen: Indefinitely

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. 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.

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.

Hotline History
N/A
CPT Codes

81263

Components
Component Test Code* Component Chart Name LOINC
0040229 IGHV Mutation Analysis by Sequencing 48670-4
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • IGHV genes
  • IGHV mutation status
  • IgVH gene mutation
IGHV Mutation Analysis by Sequencing