Islet Cell Antibody Screen with Reflex to Titer

Test Code

36741

CPT Codes
86341

Includes

If Islet Cell Antibody Screen is positive, then Islet Cell Antibody Titer will be performed at an additional charge (CPT code(s): 86341).

Preferred Specimen

2 mL serum

Patient Preparation
Fasting specimen is preferred

Minimum Volume

0.5 mL

Transport Container

Plastic screw-cap vial

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 48 hours
Refrigerated: 14 days
Frozen: 6 months

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

Gross hemolysis • Grossly lipemic • Grossly icteric

Methodology
Immunofluorescence Assay (IFA)

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-Thurs; Report available: 5-9 days

Reference Range

Islet Cell Antibody Screen	Negative
Islet Cell Antibody Titer	<1.25 JDF units

Clinical Significance

Type 1 diabetes is characterized by lymphocytic cell infiltrate of the pancreatic islets. Measurement of GAD-65, ICA-512, and Insulin Antibody is a highly sensitive means to assess risk and predict onset of Type 1 diabetes. There is a correlation between the number of positive antibodies and the antibody titers versus the severity of the autoimmune process.

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.