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Test Directory Chronic Lymphocytic Leukemia, IgVH Mutation Status, Cell-based

Chronic Lymphocytic Leukemia, IgVH Mutation Status, Cell-based

Test Summary

B cell chronic lymphocytic leukemia (B-CLL) is the most common leukemia in the Western world. Patients with B-CLL follow heterogeneous clinical courses. Some patients survive for prolonged periods without requiring definitive therapy, while others have short survival despite aggressive treatment. Studies have established that patients might be divided into two groups based on the V gene mutation status. Patients with mutated V gene required minimal or no chemotherapy and had prolonged survival. Patients with unmutated V gene responded poorly to continuous multi- regimen chemotherapy and had shorter survival. The delineation of mutation status is based on the degree of homology to the germline sequence. A 98% homology (or 2% mutated sequence) cut-off was found to provide a good discrimination.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate

Instructions

Do not reject specimens, send to laboratory for screening.

Whole blood collected in PPT-Potassium EDTA (white-top) tubes is unacceptable. Whole blood or bone marrow is shipped refrigerated. Do not freeze whole blood or bone marrow.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately due to short sample stability of 72 hours. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

**Alternative samples: FROZEN CELLS must be approved by the medical director before sending. Do not thaw. Must remain frozen until testing. **

Stability restrictions: Recommend samples arrive Monday through Friday a.m. within 24 hours of collection.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

Whole blood collected in: Sodium heparin (green-top) tube or ACD solution B (yellow-top) tube • Bone marrow aspirate collected in: Sodium heparin (green-top) tube

Unacceptable Specimens

N/A

Order Code

IGVH

EPIC (Premier) Code

LAB5405

Includes

N/A

CPT Code

81263

Billing Code

670099

CPT Statement

Methodology

PCR-based DNA Sequencing

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 7 days