Test Catalog

Test Id : CEE52

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CD52 Cell Expression Evaluation, Varies

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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
A short description of the method used to perform the test

Immunophenotyping

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

CD52 Cell Expression Evaluation, V

Aliases
Lists additional common names for a test, as an aid in searching

Alemtuzumab (Campath) (CD52)

Campath-1H (CD52)

CD52

CEE52

TAE

Therapeutic Antibody Evaluation

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 < or =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 < or =4 days

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Blood: 3 mL

Bone Marrow Aspirate: 1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Varies 4 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Salles G, Barrett M, Foa R, et al. Rituximab in B-cell hematologic malignancies: A review of 20 years of clinical experience. Adv Ther. 2017;34(10):2232-2273. doi:10.1007/s12325-017-0612-x

2. Bachy E, Seymour JF, Feugier P, et al. Sustained progression-free survival benefit of rituximab maintenance in patients with follicular lymphoma: Long-term results of the PRIMA study. J Clin Oncol. 2019;37(31):2815-2824. doi:10.1200/JCO.19.01073

3. Cross M, Dearden C. B and T cell prolymphocytic leukaemia. Best Pract Res Clin Haematol. 2019;32(3):217-228. doi:10.1016/j.beha.2019.06.001

4. Braun T, von Jan J, Wahnschaffe L, Herling M. Advances and perspectives in the treatment of T-PLL. Curr Hematol Malig Rep. 2020;15(2):113-124. doi:10.1007/s11899-020-00566-5

5. Strati P, Parikh SA, Chaffee KG, et al. CD49d associates with nodal presentation and subsequent development of lymphadenopathy in patients with chronic lymphocytic leukaemia. Br J Haematol. 2017;178(1):99-105. doi:10.1111/bjh.14647

Method Description
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

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® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CEE52 CD52 Cell Expression Evaluation, V 100991-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CK166 CEE52 Result No LOINC Needed
CK167 Final Diagnosis 22637-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports