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Test ID ZAP70 ZAP-70, Chronic Lymphocytic Leukemia (CLL) Prognosis

Useful For

Assessing a risk factor for disease progression in patients with B-cell chronic lymphocytic leukemia

 

Additional Tests

Test ID Reporting Name Available Separately Always Performed
FCINT Flow Cytometry Interp, 2-8 Markers No, (Bill Only) Yes

Testing Algorithm

When this test is ordered, flow cytometry interpretation, 2 to 8 markers will always be performed at an additional charge.

Method Name

Immunophenotyping

Reporting Name

ZAP-70

Specimen Type

Whole Blood ACD-B

Specimen must arrive within 72 hours of draw.

            

Container/Tube: Yellow top (ACD)

Specimen Volume: 6 mL

Collection Instructions: Specimen must be refrigerated within 9 hours of draw.

Forms: If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request Form (T726) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/hematopathology-request-form.pdf)

Specimen Minimum Volume

5 mL

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood ACD-B Refrigerated 72 hours

Clinical Information

B-cell chronic lymphocytic leukemia (CLL) is the most common leukemia in adults. Its clinical course is highly variable with survival times ranging from months to decades. The standard procedure for estimating prognosis is clinical staging systems developed by Rai and Binet. In these staging systems, most CLL patients have early-stage disease. Genetic prognostic markers such as immunoglobulin heavy chain gene mutational status and FISH studies for specific chromosomal abnormalities have now been developed to refine the risk of progressive disease. CD38 and ZAP-70 have been identified as surrogate markers for mutation status and can be evaluated by flow cytometric immunophenotyping.

 

ZAP-70 (70-kDa zeta-associated protein) is an intracellular tyrosine kinase discovered initially because of its role in T-cell signaling. It has also been found to be associated with the B-cell receptor in CLL. The expression of ZAP-70 (≥20% of B cells) has been associated with an increased risk for an adverse outcome in B-cell CLL and is considered an important risk factor in these patients. ZAP-70 expression, if present, is constant throughout the patient's clinical course and thus is a valid risk marker regardless of when it is evaluated.

Reference Values

An interpretive report will be provided.

Cautions

ZAP-70 is an intracellular activation marker in chronic lymphocytic leukemia (CLL) cells and expression can be labile after 24 hours. Failure to follow specimen processing, transportation, and storage requirements may lead to false results.

 

Bone marrow, lymph node, and tissue specimens will not be accepted as these specimen types have not been clinically validated at Mayo or in literature studies. Since B-cell CLL is, by definition, a peripheral leukemic process and since blood specimens can be easily obtained, this should not be a significant limitation.

 

A ZAP-70 study may be rejected if the histogram pattern indicates that there have been any cellular changes that could prevent accurate interpretation of antigen expression.

Day(s) Performed

Specimens are processed Monday through Sunday and reported Monday through Friday.

Report Available

3 days

Performing Laboratory

Mayo Medical 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 U.S. Food and Drug Administration.

CPT Code Information

88184 x 1-Flow cytometry; first cell surface, cytoplasmic or nuclear marker

88185 x 2–Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)

88187–Flow cytometry interpretation, 2 to 8 Markers

NY State Approved

Conditional