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Test Code MISC2MAYOCEE52 CD52 Cell Expression Evaluation, Varies


Ordering Guidance


This test should not be used as a shortened diagnostic panel. For a complete diagnostic B-cell, T-cell, or acute immunophenotyping panel, order LCMS / Leukemia/Lymphoma Immunophenotyping, Flow Cytometry, Varies.

 

This test evaluates CD52 expression only. For CD20 expression, order CEE20 / CD20 Cell Expression Evaluation, Varies. For CD49d expression, order CEE49 / CD49d Cell Expression Evaluation, Varies.



Shipping Instructions


Specimen must arrive within 4 days of collection.



Necessary Information


The following information is required:

1. The therapeutic monoclonal antibody being used or considered

2. The pertinent hematologic diseases that have been diagnosed or considered

3. Diagnostic immunophenotype of the neoplastic cells (when available, a pathology and/or flow cytometry report should be included).

4. Specimen source

5. Date and time of collection



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Whole Blood

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA) or Green top (sodium heparin) 

Specimen Volume: 10 mL

Collection Instructions:

1. Send specimen in original tube. Do not aliquot.

2. Label specimen as blood.

Specimen Stability Information: Ambient/Refrigerated ≤4 days

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD solution A or B)

Acceptable: Lavender top (EDTA) or Green top (sodium heparin) Specimen Volume: 1-5 mL

Collection Instructions:

1. Submission of bilateral specimens is not required.

2. Label specimen as bone marrow.

3. Send bone marrow specimen in original tube. Do not aliquot.

Specimen Stability Information: Ambient/Refrigerated ≤4 days


Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Secondary ID

65659

Useful For

Detecting cell-surface antigens on malignant cells that are potential therapeutic antibody targets, specifically CD52

 

Determining the eligibility of patients for monoclonal antibody therapies

 

Monitoring response to the therapeutic antibody

Testing Algorithm

A complete diagnostic B-cell, T-cell, or acute immunophenotyping panel is not performed. In some cases, a limited morphologic evaluation will be performed.

Method Name

Immunophenotyping

Reporting Name

CD52 Cell Expression Evaluation, V

Specimen Type

Varies

Specimen Minimum Volume

Blood: 3 mL
Bone Marrow Aspirate: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies 4 days

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

Monoclonal antibodies are critical tools for detecting cellular antigens in various hematologic diseases and are used to provide critical prognostic information (eg, CD49d). Monoclonal antibodies are also used as therapeutic agents in a variety of hematologic diseases. For example:

-Anti-CD20 (Rituxan): B-cell malignant lymphomas and multiple myeloma

-Anti-CD52 (Campath-1H): B-cell chronic lymphocytic leukemia and T-cell disorders

This list will undoubtedly expand over time to include other antibodies.

 

It may be necessary to document expression of these markers by the malignant cells prior to initiating the respective monoclonal antibody therapy. Expression of these markers may also be required for follow-up to monitor the impact of treatment on residual normal counterparts (eg, CD20-positive lymphocytes in patients treated with anti-CD20).

The distribution of these cellular antigens is well established in normal, reactive, and in various malignant disorders. The laboratory has several years of experience with therapeutic antibody monitoring of Mayo Clinic patients as part of the routine B-cell, T-cell, or acute immunophenotyping panels.

Reference Values

Normal individuals have B lymphocytes, T lymphocytes, or myeloid cells that express the corresponding cell-surface antigens in question.

Interpretation

The immunophenotyping report will summarize the pattern of antigenic expression on malignant cells and, if appropriate, the normal cellular counterparts that correspond to the therapeutic monoclonal antibody target.

Method Description

Flow cytometric immunophenotyping of peripheral blood, bone marrow, or tissue-derived lymphocytes is performed to assess the expression of the cell-surface antigen corresponding to the monoclonal antibody therapeutic target. The following antibody panel will be used:

-Anti-CD52 assessment: CD52/CD19/CD3/CD45

(Keren P, McCoy Jr JP, Carey J eds. Flow Cytometry in Clinical Diagnosis. 4th ed. ASCP Press; 2007)

Day(s) Performed

Monday through Saturday

Report Available

1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker

88185 x 3-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker

88187-Flow Cytometry Interpretation, 2 to 8 Markers

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CEE52 CD52 Cell Expression Evaluation, V 100991-9

 

Result ID Test Result Name Result LOINC Value
CK166 CEE52 Result No LOINC Needed
CK167 Final Diagnosis 22637-3