CPT Code(s):
88346, 86337
Specimen Requirements:
Collect blood in a 1- 5 mL serum separator tube. Centrifuge, separate and transfer the serum to a plastic vial. Ship specimens with a frozen cold pack for overnight delivery.
Stability (collection to shipping of the sample):
- Ambient: 24 hours
- Refrigerated: 24 hours
- Frozen: 1 year (Avoid repeated freeze/thaw cycles.)
Use:
- Diagnosis of Type 1 Diabetes: The presence of autoantibodies against the islet cells (ICA) or insulin (IAA) in patients with diabetes mellitus indicates the presence of autoimmune type 1 diabetes. It is advised that blood for IAA testing be drawn before insulin therapy is initiated. For the IAA result to be valid, the patient must not be insulin treated for more than two weeks.
- Prediction of Type 1 Diabetes: ICA or IAA in an asymptomatic individual places the subject at increased risk for the development of type 1 diabetes. It is not recommended that asymptomatic, nondiabetic persons be screened for ICA or IAA unless they are part of a research study.
Methodology:
ICA: Indirect immunofluorescence
Reported:
10 – 20 business days
Reference Values:
- ICA:
- Negative (quantitative results reported in JDF units): < 10 JDF units
- Positive: ≥ 10 JDF units
- IAA:
- Negative: < 95 nU/mL
- Indeterminate: 95 – 125 nU/mL
- Positive: < 125 nU/mL