Assesses for single gene mutations, including substitutions and smaller insertions and deletions that may have implications for prognosis or clinical management in patients with chronic lymphocytic leukemia or other B-cell lymphoproliferative disorders.
Massively Parallel Sequencing
Lavender (K2 or K3EDTA). Also acceptable: Bone Marrow (K2 or K3EDTA) or Fresh-frozen tissue.
Whole Blood: Do not freeze. Transport 3 mL whole blood. (Min: 1.5 mL)
Bone Marrow: Do not freeze. Transport 3 mL bone marrow. (Min: 1.5 mL
Fresh-frozen Tissue: Transport 5 mg fresh-frozen tissue. (Min: 5 mg)
Separate specimens must be submitted when multiple tests are ordered
Whole Blood or Bone Marrow: Refrigerated.
Fresh-frozen Tissue: Frozen.
Whole Blood or Bone Marrow: Specimens collected in anticoagulants other than EDTA. Clotted or grossly hemolyzed specimens.
Whole Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable
Fresh-frozen Tissue: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 1 month
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.
Genes tested: ATM, BCL2, BIRC3*, BRAF, BTG1, BTK, CARD11, CD79B, CXCR4, DDX3X, FBXW7, IKZF3, KRAS, MAP2K1, MED12, MGA, MYD88, NOTCH1, NRAS, PLCG2, POT1, RPS15*, SAMHD1, SF3B1, TP53, XPO1, ZMYM3
* - One or more exons are not covered by sequencing for the indicated gene; see Additional Technical Information test fact sheet.
|Component Test Code*||Component Chart Name||LOINC|
|3001859||Chronic Lymphocytic Leukemia Specimen||31208-2|
|3001860||Chronic Lymphocytic Leukemia Interp||35506-5|
|3002513||EER, CLL Panel by NGS||11526-1|
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Monoclonal B-cell lymphocytosis
- Non-Hodgkin lymphoma
- Small lymphocytic leukemia