Ordering Recommendation

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.

Mnemonic
CLL NGS
Methodology

Massively Parallel Sequencing

Performed

Varies

Reported

12-14 days

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Specimen Required
Patient Preparation
Collect

Lavender (K2 or K3EDTA). Also acceptable: Bone Marrow (K2 or K3EDTA) or Fresh-frozen tissue.

Specimen Preparation

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

Storage/Transport Temperature

Whole Blood or Bone Marrow: Refrigerated.
Fresh-frozen Tissue: Frozen.

Unacceptable Conditions

Serum, plasma.
Whole Blood or Bone Marrow: Specimens collected in anticoagulants other than EDTA. Clotted or grossly hemolyzed specimens.

Remarks
Stability

Whole Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable
Fresh-frozen Tissue: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 1 month

Reference Interval

By report

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

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.

Hotline History
N/A
CPT Codes

81450

Components
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
* 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
  • Lymphocytosis
  • NHL
  • Chronic lymphocytic leukemia
  • CLL
  • CLL/SLL
  • Mantle cell lymphoma
  • MBL
  • MCL
  • Monoclonal B-cell lymphocytosis
  • Non-Hodgkin lymphoma
  • SLL
  • Small lymphocytic leukemia
Chronic Lymphocytic Leukemia Mutation Panel by Next Generation Sequencing