Chronic Lymphocytic Leukemia (CLL) Prognostic Panel, Comprehensive

Test Code
CLLPP


Alias/See Also
<p>LAB12145</p>


CPT Codes
<p>81263, 82232, 88184, 88185 (x2), 88237, 88264, 88271 (x6), 88275 (x3)</p>

Includes
Beta-2-Microglobulin, Serum
Chromosome Analysis, CLL/LPD
Chronic Lymphocytic Leukemia, IgVH Mutation Status, Cell-based
CD38+ CLL cells
FISH, B-Cell Chronic Lymphocytic Leukemia Panel
ZAP-70


Preferred Specimen
<p style="margin-left: 0in; margin-right: 0in;"><strong>Serum and EDTA whole blood and sodium heparin whole blood are required for this panel.</strong></p>
<p style="margin-left: 0in; margin-right: 0in;">&nbsp;</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Type:</strong>&nbsp;Serum</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Collection Container/Type</strong></p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Preferred:</strong>&nbsp;<a href="https://inovalaboratories.testcatalog.org/catalogs/662/files/12246">Serum gel</a></p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Acceptable:</strong>&nbsp;<a href="https://inovalaboratories.testcatalog.org/catalogs/662/files/12243">Red top</a></p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Submission Container/Tube:</strong>&nbsp;Plastic vial</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Volume:</strong>&nbsp;1 mL</p>
<p style="margin-left: 0in; margin-right: 0in;">&nbsp;</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Type:</strong>&nbsp;Whole Blood EDTA</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Collection Container/Type</strong>:&nbsp;<a href="https://inovalaboratories.testcatalog.org/catalogs/662/files/12233">Lavender top (EDTA)</a></p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Submission Container/Tube:</strong>&nbsp;Original tube, do not aliquot</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Volume:</strong>&nbsp;5 mL</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Additional Information:</strong></p>
<ul>
<li>Whole blood collected in PPT-Potassium EDTA (white-top) tubes is unacceptable</li>
</ul>
<p style="margin-left: 0in; margin-right: 0in;">&nbsp;</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Type:</strong>&nbsp;Whole Blood (Sodium Heparin)</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Collection Container/Type</strong>:&nbsp;<a href="https://inovalaboratories.testcatalog.org/catalogs/662/files/12241">Green top (Sodium heparin)</a></p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Submission Container/Tube:</strong>&nbsp;Original tube, do not aliquot</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Specimen Volume:</strong>&nbsp;16 mL</p>


Minimum Volume
<p>3 mL EDTA whole blood &bull; 10 mL sodium heparin whole blood &bull; 0.5 mL serum</p>


Instructions
See individual tests


Transport Temperature
Room temperature


Specimen Stability
<p style="margin-left: 0in; margin-right: 0in;"><strong>Room temperature</strong>: 72 hours</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Refrigerated</strong>:&nbsp;Unacceptable</p>
<p style="margin-left: 0in; margin-right: 0in;"><strong>Frozen</strong>:&nbsp;Unacceptable</p>
<p style="margin-left: 0in; margin-right: 0in;">&nbsp;</p>
<p style="margin-left: 0in; margin-right: 0in;">Specimen viability decreases during transit. Send specimen to testing lab for viability determination.&nbsp;<strong>Do not freeze. Do not reject.</strong></p>


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
<p>Hemolysis &bull; Lipemia</p>


Methodology
<p>Culture &bull; Flow Cytometry (FC) &bull; Fluorescence in situ Hybridization (FISH) &bull; Immunoturbidometric &bull; Karyotype &bull; Polymerase Chain Reaction (PCR) &bull; Sequencing</p>
<p>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.</p>

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
<p>Mon, Thurs</p>


Report Available
<p>10 days</p>


Reference Range
See Laboratory Report


Clinical Significance
Chronic Lymphocytic leukemia is the most common leukemia in the Western world. The disease is chronic and most patients may not require therapy in the early stage of the disease. However, in some patients the disease can be aggressive and within a year the tumor mass may increase significantly imposing serious health problems to the patient. It is difficult to determine based on clinical presentation which patient will progress faster than the others. Therefore, there is a need to use more accurate prognostic indicator to predict the clinical course of this disease. The recent advances in CLL therapy and biology made it possible to develop new tests and a combination of these tests.


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



Last Updated: February 20, 2023


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.