Determine risk group in newly diagnosed CLL.
Polymerase Chain Reaction/Sequencing
New York DOH Approval Status
Lavender (EDTA) or bone marrow (EDTA). Also acceptable: RNA extracted by CLIA certified lab.
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.
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.
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.
Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
Extracted RNA: Ambient: Unacceptable; Refrigerate: Unacceptable; Frozen: Indefinitely
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
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.
|Component Test Code*||Component Chart Name||LOINC|
|0040229||IGHV Mutation Analysis by Sequencing||48670-4|
- IGHV genes
- IGHV mutation status
- IgVH gene mutation