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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
8-12 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). 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
View Hotline History
Components
Component Test Code*Component Chart NameLOINC
0040229IGHV Mutation Analysis by Sequencing48670-4
* 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