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Test Code DBS1 Diabetes Mellitus Type 1 Evaluation, Serum

Useful For

Distinguishing type 1 from type 2 diabetes mellitus

 

Identifying individuals at risk of type 1 diabetes (including high-risk relatives of patients with diabetes)

 

Predicting future insulin requirement treatment in patients with adult-onset diabetes

Profile Information

Test ID Reporting Name Available Separately Always Performed
DMEI Diabetes Interpretation, S No Yes
GD65S GAD65 Ab Assay, S Yes Yes
INAB Insulin Abs, S Yes Yes
IA2 IA-2 Ab, S Yes Yes
EZNT8 ZnT8 Ab, S Yes Yes

Method Name

GD65S, INAB, IA2: Radioimmunoassay (RIA)

EZNT8: Enzyme-Linked Immunosorbent Assay (ELISA)

DMEI: Interpretive Comments

Reporting Name

Diabetes Mellitus Type 1 Evaluation

Specimen Type

Serum


Specimen Required


Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 4 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  72 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Clinical Information

Islet cell autoantibodies have been known to be associated with type 1 diabetes mellitus since the 1970s. Since 1988, several autoantigens, against which islet antibodies are directed, have been identified. These include the insulinoma-associated protein 2 (IA-2), glutamic acid decarboxylase 65 (GAD65), insulin and, most recently, the zinc transporter ZnT8.(1) Only 4% to 7% of patients with type 1 diabetes are autoantibody negative, fewer than 10% have only 1 marker, and around 70% have 3 or 4 markers. These findings have been confirmed in multiple specialty laboratories internationally.

 

One or more of these autoantibodies are detected in 93% to 96% of patients with type 1 diabetes, both adults and children. These antibodies are also detectable in relatives of type 1 diabetic patients at risk for developing diabetes, before clinical onset.(2) Some patients with type 1 diabetes are initially diagnosed as having type 2 diabetes because of symptom-onset in adulthood, societal obesity, and initial insulin-independence. These patients with either "latent autoimmune diabetes in adulthood" or type 1 diabetes mellitus may be distinguished from those patients with type 2 diabetes by detection of 1 or more islet autoantibodies (including ZnT8 antibody). Patients with gestational diabetes can also be stratified for future diabetes risk by detection of 1 or more islet autoantibodies.

Reference Values

GLUTAMIC ACID DECARBOXYLASE (GAD65) ANTIBODY

≤0.02 nmol/L

Reference values apply to all ages.

 

INSULIN ANTIBODIES

≤0.02 nmol/L

Reference values apply to all ages.

 

ISLET ANTIGEN 2 (IA-2) ANTIBODY

≤0.02 nmol/L

Reference values apply to all ages.

 

ZINC TRANSPORTER 8 (ZnT8) ANTIBODY

< 15.0 U/mL

Reference values apply to all ages.

Day(s) Performed

GAD65 antibody: Monday through Friday

Insulin antibodies: Monday, Wednesday, Friday

IA-2 antibody, Zinc Transporter 8 Antibody: Tuesday, Thursday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

See Individual Test IDs

CPT Code Information

86337

86341 x3