Leukemia/Lymphoma Evaluation

Test Code

35080

CPT Codes
88184, 88185 (x21), 88189<br>This test is for non-New York patient testing. For New York patient testing use test code 37340

Includes

Initial markers evaluated: CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11c, CD13, CD19, CD20, CD23, CD33, CD34, CD38, CD56, CD64, CD117, HLA-DR, sKappa, sLambda. CD45 is used for gating.

Additional markers may be performed based on the pathologist review. These markers will be performed at an additional charge (CPT code(s): 88185 for each additional marker).

Preferred Specimen

Peripheral blood: 4 mL collected in a sodium heparin (green-top) tube, ACD-A (yellow-top) tube, or EDTA (lavender-top) tube or

Bone marrow: 3 mL collected in a sodium heparin (green-top) tube, ACD-A (yellow-top) tube,or EDTA (lavender-top) tube or

Tissue or body fluids: Any type is acceptable

Minimum Volume

3 mL peripheral blood • 1 mL bone marrow

Other Acceptable Specimens

Bone marrow collected in a Pediatric heparin tube

Instructions

Peripheral blood and bone marrow: The tube must be kept at room temperature and shipped to the lab immediately.

Tissue: Any tissue type is acceptable. Tissue size is dependent upon leukocyte cellularity. (The tissue is disaggregated into single cells so that a minimum of 50,000 cells of interest are harvested.) Ship tissue in a sterile plastic container with RPMI 1640 enriched with FBS (10% FBS RPMI). Absolutely no fixative should be added. Refrigerate and ship immediately.
⁠⁠⁠⁠⁠⁠⁠
Body Fluids: Any body fluid is acceptable. Sample size is dependent upon cellularity of the sample. (A minimum of 50,000 cells of interest in total volume of fluid). Place fluid in sterile plastic container. Absolutely no fixative should be added. Refrigerate and ship immediately.

A clinical indication and specimen source are required with each specimen. If possible, submit CBC results with differential or an EDTA tube of peripheral blood.
Do not freeze and do not place in fixative.

Because of the critical nature of these specimens, the laboratory will attempt to process all specimens received, regardless of age of specimen.

Transport Temperature

Peripheral blood and bone marrow: Room temperature
Tissue and body fluids: Refrigerate (cold packs)

Specimen Stability

Peripheral blood and bone marrow
Room temperature: 72 hours (may extend to 5 days, depending on cell viability)
Refrigerated: Not established
Frozen: Not established

Tissue and body fluids
Room temperature: Not established
Refrigerated: 72 hours
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

See Collection Instructions

Methodology
Flow Cytometry (FC)

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

Setup Schedule

Set up: Mon-Sat; Report available: 2 days

Reference Range

See Laboratory Report

Clinical Significance

This panel may be used in the initial evaluation of patients with clinical suspicion of hematologic neoplasms. Immunophenotyping by flow cytometry can aid in the diagnosis and classification of leukemia and lymphoma [1]. Subsequent testing of additional cell surface antigens may be needed to help establish a diagnosis.

Leukemias and lymphomas are heterogenous morphologically and clinically. Identification of cell surface markers (T cell, B cell, progenitor, and myeloid markers) by flow cytometry can help assign a cell lineage to neoplastic cells. Accurate immunotyping aids in the diagnosis, classification, and prognosis of hematologic neoplasm and may inform treatment decisions [1].

This immunotyping panel is designed to expedite the evaluation of patients without provisional diagnosis of a certain type of hematologic neoplasm. The results of this panel must be interpreted with cytological, histological, genetic, and clinical findings to generate accurate diagnosis. Additional cell surface markers not included in this panel may be needed to evaluate certain hematologic malignancies (eg, hairy cell leukemia).

Because non-viable cells lead to non-specific antibody binding, specimens should be processed as early as possible.

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

Reference
1. Bain BJ, et al. Leukaemia Diagnosis. 5th ed. John Wiley & Sons;2017:69-134.

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

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.