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 (EDTA), Green (sodium heparin), Bone Marrow (EDTA), or Bone Marrow (sodium heparin). Fresh-frozen tissue

Specimen Preparation

Whole Blood and Bone Marrow: Transport 3 mL. (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, grossly hemolyzed specimens, buccal brush or swab, FFPE tissue.

Remarks
Stability

Whole Blood or Bone Marrow: Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable
Fresh-frozen Tissue:
Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 1 month

Reference Interval

By report

Interpretive Data

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.

Compliance Category

Laboratory Developed Test (LDT)

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