Chronic Lymphocytic Leukemia, IgVH Mutation Status, Cell-based [15480]

For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

Test Code

Alias/See Also

CPT Codes

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

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

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.

Transport Temperature
Refrigerated (cold packs)

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

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 7 days

Reference Range
See Laboratory Report

Clinical Significance
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.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: November 29, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.