3001858
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Chronic Lymphocytic Leukemia Mutation Panel by Next Generation Sequencing

CLL NGS
Example Reports
Enhanced Report
Negative
Positive

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Additional Technical Information

Ordering Recommendation

Use to assess for single gene variants, including substitutions and smaller insertions and deletions that may have implications for prognosis or clinical management in patients with chronic lymphocytic leukemia (CLL) or other B-cell lymphoproliferative disorders.

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), green (sodium heparin), bone marrow (EDTA), or bone marrow (sodium heparin). Fresh-frozen tissue.
New York State Clients: Lavender (EDTA)

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.
New York State Clients: Transport 5 mL whole blood (Min: 2 mL) or 2 mL bone marrow (Min: 2 mL).

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

Specimen source is required.

Stability

Whole Blood or Bone Marrow: Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable
Fresh-Frozen Tissue: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 1 month
New York State Clients: Ambient: 72 hours; Refrigerated: 4 days; Frozen: Unacceptable

Methodology

Massively Parallel Sequencing

Performed

Varies

Reported

12-14 days

Reference Interval

By report

Interpretive Data

Refer to report.

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; RNASEH2A; RNASEH2B; 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

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
03/06/2023
X
N/A

CPT Codes

81450

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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