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Islet Cell Antibody Screen with Reflex to Titer : 36741
Test CodeISLETQ or 36741
CPT Codes
86341
Includes
If Islet Cell Antibody Screen is positive, Islet Cell Antibody Titer will be performed at an additional charge (CPT code(s): 86341). (If reflex: non-orderable 36741-2)
Instructions
Serum separator tube or plain red tube.
Transport Container
Centrifuge serum separator tube and transport. If plain red, centrifuge and aliquot 2 mL serum (Min: 0.5 mL) into a standard transport tube.
Transport Temperature
Refrigerated.
Specimen Stability
Ambient: 48 hours; Refrigerated: 14 days; Frozen: 6 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis; Lipemia; Icteric.
Methodology
Immunofluorescence Assay (IFA)
Setup Schedule
Monday - Thursday
Report Available
4-8 days (From receipt at performing laboratory)
Limitations
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
Islet Cell Ab Screen: Negative
If reflex to titer:
Islet Cell Ab Titer: less than 1.25 JDF units
Note: End point titers are compared to a single international reference standard and values are reported in JDF (Juvenile Diabetes Foundation) units.
If reflex to titer:
Islet Cell Ab Titer: less than 1.25 JDF units
Note: End point titers are compared to a single international reference standard and values are reported in JDF (Juvenile Diabetes Foundation) 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