Islet Cell Autoantibodies Evaluation

Overview

  • EPIC Code:
  • IMO208
  • Soft Test Code:
  • ISLE
  • Send Out Test Code:
  • 36741
Alternate Names
  • Islet Cell Antibody Screen with Reflex to Titer
  • Islet Cell Eval
Included Tests

Islet Cell Autoantibodies CF; Islet Cell IgG Autoantibodies


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.


Specimen Collection & Preparation

Patient Preparation

 Fasting prior to collection preferred


Specimen Requirements:

-OR-

2.0 mL Serum from a Red Top Tube in a Plastic Vial
Minimum Volume:
0.5 mL Serum*

* This volume does not allow for repeat testing

Rejection Criteria:

Gross hemolyzed

Grossly lipemic

Grossly icteric


Transport and Storage:
  • Ambient (18-24°C): 48 Hours
  • Refrigerated (2-8°C): 14 Days

    Transport

  • Frozen (-20° C or colder): 6 Months

Clinical Interpretation

Reference Range:

Islet Cell Antibody Screen Negative
Islet Cell Antibody Titer <5 JDF units


Test Comments:

If Islet Cell Antibody Screen is positive, then Islet Cell Antibody Titer will be performed at an additional charged 


Methodology:
  • Immunofluorescence Assay (IFA)
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.


Documentation

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.


Production Schedule

Sites Performed
  • Quest - Chantilly to San Juan Capistrano
Days Performed
Monday
Tuesday
Wednesday
Thursday
Departments
  • Sendouts - Clinical
Turn Around Time

5 to 9 days


Coding & Compliance

CPT Coding

86341 Reflex 86341