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 Category

Laboratory Developed Test (LDT)

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