Determine risk group in newly diagnosed CLL.
Polymerase Chain Reaction/Sequencing
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.
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.
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