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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. Within 24 hours of collection, centrifuge and aliquot 2.5 mL of serum into a plastic vial.

2. Freeze within 24 hours and send frozen.


Secondary ID

75937

Useful For

Diabetes autoantibodies assessment is helpful in identifying and managing patients at risk for development of type 1 diabetes.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoprecipitation

Reporting Name

Diabetes Autoimmune Profile

Specimen Type

Serum

Specimen 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 days

Performing Laboratory

Esoterix Endocrinology

Test 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

Interpretation

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.(1)

 

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.