Test ID: TAE
Therapeutic Antibody by Flow Cytometry
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Determining the eligibility of patients for monoclonal antibody therapies
Monitoring response to the therapeutic antibody
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 88465 | Flow Cytometry Interp, 2-8 Markers | No, (Bill Only) | No |
| 88466 | Flow Cytometry Interp, 9-15 Markers | No, (Bill Only) | No |
| 88467 | Flow Cytometry Interp,16 or greater | No, (Bill Only) | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When a blood or bone marrow is ordered, a panel specific to desired antibody and a professional interpretation will always be charged. The panel will be charged based on number of makers tested (80997 for first marker, 81047 for each additional marker). The interpretation will be set based on markers tested in increments of 2 to 8, 9 to 15, or 16 and greater.
Method Name A short description of the method used to perform the test
Flow Cytometry
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Campath-1H (CD52)
CD20
CD33
CD52
Epratuzumab (hLL2) (CD22)
Gemtuzumab (Mylotarg) (CD33)
hLL2 (Epratuzumab) (CD22)
Ibritumomab Tiuxetin (Zevalin) (CD20)
IDEC-Y2B (CD20)
Mylotarg (Gemtuzumab) (CD33)
Rituximab (Rituxan) (CD20)
Tositumomab (Bexxar) (CD20)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Date of draw and the specific therapeutic monoclonal antibody being used or considered are required. Include the pertinent hematologic diseases that have been diagnosed or considered.
Forms: If not ordering electronically, please submit a Hematopathology/Molecular Oncology Request Form (Supply T241) with the specimen.
Submit only 1 of the following specimens:
Specimen Type: Blood
Container/Tube:
Preferred: Yellow top (ACD solution B)
Acceptable: ACD (solution A), heparin, EDTA
Specimen Volume: 10 mL
Collection Instructions:
1. Do not transfer blood to other containers.
2. Include 5- to 10-unstained blood smears, if possible.
3. Label specimen as blood.
Specimen Type: Bone marrow
Container/Tube:
Preferred: Yellow top (ACD solution B)
Acceptable: ACD (solution A), heparin, EDTA
Specimen Volume: 1-5 mL
Collection Instructions:
1. Label specimen as bone marrow.
2. Submission of bilateral specimens is not required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Varies | |
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 diagnostic information. 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-CD25: B-cell and T-cell leukemias and lymphomas
-Anti-CD52 (Campath-1H): B-cell chronic lymphocytic leukemia and T-cell disorders
-Anti-CD33: acute myeloid leukemia
-Anti-CD49d: estimates prognosis for B-cell chronic lymphocytic leukemia patients
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).
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 necessary, 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
The requesting physician must provide the laboratory with:
-The therapeutic monoclonal antibody being used or considered
-The pertinent hematologic diseases that have been diagnosed or considered
-Any pertinent protocol requirements
A complete diagnostic B-cell, T-cell, or acute immunophenotyping panel will not be performed and must be ordered separately (LCMS/3287 Leukemia/Lymphoma Immunophenotyping by Flow Cytometry). In some cases, a limited morphologic evaluation will be performed. This test should not be used as a shortened diagnostic panel.
Supportive Data
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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Davis AT: Monoclonal antibody-based therapy of lymphoid neoplasms: what's on the horizon? Semin Hematol 2000;37(4 Suppl 7):34-42
2. Czuczman MS, Grillo-Lopez AJ, White CA, et al: Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol 1999;17:268-276
3. Flynn JM, Byrd JC: Campath-1H monoclonal antibody therapy. Curr Opin Oncol 2000;12:574-581
4. Kreitman RJ, Wilson WH, Bergeron K, et al: Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N Eng J Med 2001;345:241-247
5. van der Velden VH, te Marvelde JG, Hoogeveen PG, et al: Targeting of the CD33-calicheamicin immunoconjugate Mylotarg (CMA-676) in acute myeloid leukemia: in vivo and in vitro saturation and internalization by leukemic and normal myeloid cells. Blood 2001;97:3197-3204
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 panels will be used:
-Anti-CD20 assessment - kappa/lambda/CD19/CD20
-Anti-CD25 assessment - CD25/CD19/CD3/CD45
-Anti-CD49d assessment - CD19/CD49d/CD3/CD45
-Anti-CD52 assessment - CD52/CD19/CD3/CD45
-Anti-CD33 assessment - HLA-DR/CD13/CD34/CD33/CD117/CD45
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Specimens are processed Monday through Sunday and reported Monday through Friday.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker
88185/x6-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 19967 | Accession Number | N/A |
| 19968 | Referring Pathologist/Physician | 46608-6 |
| 19969 | Ref. Path Address | In Process |
| 19970 | Material | In Process |
| 19971 | Specimen: | 31208-2 |
| 19972 | Bone Marrow Differential | 47286-0 |
| 19973 | Peripheral Blood: | N/A |
| 19974 | Aspirate: | N/A |
| 19975 | Biopsy | 52121-1 |
| 19976 | Microscopic Description | In Process |
| 19977 | Special Studies: | N/A |
| 19978 | Final Diagnosis: | 34574-4 |
| 19979 | Comment: | 48767-8 |
| 19980 | Revision Description: | In Process |
| 19981 | Signing Pathologist | 19139-5 |
| 19982 | Special Procedures | N/A |
| 19983 | SP Signing Pathologist | N/A |
| 19984 | *Previous Report Follows* | N/A |
| 19985 | Addendum | 35265-8 |
| 19986 | Addendum Comment: | 22638-1 |
| 19987 | Addendum Pathologist: | 19139-5 |
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