Islet Cell Antibody Screen with Reflex to Titer

Islet Cell Antibody Screen with Reflex to Titer

Test Code

36741
86341
36741
86341
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

Islet Cell Antibody Screen with Reflex to Titer - 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.

Test Resources

Test FAQ

Autoantibodies and Type 1 Diabetes (T1D)

Test Details

Includes

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

Patient Preparation

Fasting specimen is preferred

Methodology

Immunofluorescence Assay (IFA)

Assay Category

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.

Reference Range(s)

Islet Cell Antibody ScreenNegative
  Islet Cell Antibody Titer<5 JDF units

LOINC® Codes, Performing Laboratory

Service Area must be determined
If Islet Cell Antibody Screen is positive, then Islet Cell Antibody Titer will be performed at an additional charge (CPT code(s): 86341).
Fasting specimen is preferred

Methodology

Immunofluorescence Assay (IFA)
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.

Reference Range(s)

Islet Cell Antibody ScreenNegative
  Islet Cell Antibody Titer<5 JDF units
Service Area must be determined

Preferred Specimen(s)

2 mL serum

Minimum Volume

0.5 mL

Transport Container

Transport tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 48 hours

  • Refrigerated: 14 days
  • Frozen: 6 months

Reject Criteria

Gross hemolysis • Grossly lipemic • Grossly icteric

Setup Schedule

Service Area must be determined

2 mL serum

0.5 mL
Transport tube
Refrigerated (cold packs)

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

Gross hemolysis • Grossly lipemic • Grossly icteric
Service Area must be determined
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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