Islet Cell Antibody Screen with Reflex to Titer
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL serum
Minimum Volume
0.5 mL
Instructions
N/A
Patient Preparation
Fasting specimen is preferred
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 48 hours
- Refrigerated: 14 days
- Frozen: 6 months
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Grossly icteric
Order Code
ISLETS
EPIC (Premier) Code
LAB051
Includes
If Islet Cell Antibody Screen is positive, then Islet Cell Antibody Titer will be performed at an additional charge (CPT code(s): 86341).
CPT Code
- 86341
Billing Code
- 670111
CPT Statement
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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
| Islet Cell Antibody Screen | Negative |
| Islet Cell Antibody Titer | <1.25 JDF units |
Setup Schedule / Expected Turnaround Time
Monday - Thursday; Report available: 5 - 9 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL serum
Minimum Volume
0.5 mL
Instructions
N/A
Patient Preparation
Fasting specimen is preferred
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 48 hours
- Refrigerated: 14 days
- Frozen: 6 months
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Grossly icteric
Result Information
Methodology
Immunofluorescence Assay (IFA)
Testing Laboratory
N/A
Reference Range
| Islet Cell Antibody Screen | Negative |
| Islet Cell Antibody Titer | <1.25 JDF units |
Setup Schedule / Expected Turnaround Time
Monday - Thursday; Report available: 5 - 9 days