Test Code FDAIP Diabetes Autoimmune Profile
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/tube: Plastic vial
Specimen Volume: 2.5 mL
Collection Instructions:
1. Centrifuge and aliquot 2.5 mL of serum into a plastic vial.
2. Freeze immediately and send frozen.
Secondary ID
75937Useful For
Published positivity rates for diabetes autoantibodies in new-onset Type 1 diabetes patients listed below are based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and ZNT8 antibodies. The combined analysis has a 98% autoimmunity detection rate, with 1.8% of Type 1 diabetic individuals remaining as autoantibody-negative.
Positive rate in new-onset type 1 diabetes patients:
GAD-65 antibodies = 68% positive
ICA 512 antibodies = 72% positive
Insulin antibodies = 55% positive
ZnT8 antibodies = 63% positive
An increase in the number of positive antibodies is associated with a higher likelihood of type 1 diabetes.
Less than 3% of Type 2 diabetics have positive antibodies.(1)
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoprecipitation
Reporting Name
Diabetes Autoimmune ProfileSpecimen Type
SerumSpecimen Minimum Volume
1 mL (Note: This volume does not allow for repeat testing)
Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Serum | Frozen | 7 days |
Reject Due To
Gross hemolysis | Reject |
Thawing | Cold OK; Warm reject |
Lipemia | Reject |
EDTA plasma | Reject |
Reference Values
Insulin Antibodies
<5.0 uU/mL: Negative
≥5.0 uU/mL: Positive
Anti GAD 65 Antibodies
<5.0 U/mL: Negative
≥5.0 U/mL: Positive
IA-2 Autoantibodies
<7.5 U/mL: Negative
≥7.5 U/mL: Positive
ZNT8 Antibodies
<15 U/mL: Negative
≥15 U/mL: Positive
Reference ranges apply to all ages.
Day(s) Performed
Varies
Report Available
10 to 19 daysPerforming Laboratory
Esoterix EndocrinologyTest Classification
Insulin Antibodies: This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.CPT Code Information
86337
86341x3
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
FDAIP | Diabetes Autoimmune Profile | Not Provided |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
Z6377 | Insulin Antibodies | 8072-1 |
Z6378 | Anti GAD 65 Antibodies | 56540-8 |
Z6387 | IA-2 Autoantibodies | 31209-0 |
Z6388 | ZNT8 Antibodies | 76651-9 |
Z6389 | Type 1 Diabetes Interpretation | 8251-1 |