IGHV Mutation Analysis by Sequencing
0040227
Ordering Recommendation
Determine risk group in newly diagnosed CLL.
Mnemonic
IGHV MUT
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Varies
Reported
12-14 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
- Patient Preparation
- Collect
- Lavender (EDTA) or bone marrow (EDTA).
- Specimen Preparation
- Transport 5 mL whole blood OR 3 mL bone marrow. (Min: 1 mL whole blood OR 1 mL bone marrow) Specimens must be received within 48 hours of collection due to lability of RNA..
- Storage/Transport Temperature
- Refrigerated.
- Unacceptable Conditions
- Serum or plasma. Frozen or clotted specimens. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed specimens.
- Remarks
- Stability
- Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
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
View Hotline History
CPT Code(s)
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 0040229 | IGHV Mutation Analysis by Sequencing | 48670-4 |
Aliases
- IGHV genes
- IGHV mutation status
- IgVH gene mutation