Epic Test Code LAB25232 Diabetes Mellitus Type 1 Evaluation, Serum
Additional Codes
MML:DBS1
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 EvaluationSpecimen Type
SerumSpecimen 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.
Blood Tube Draw Volume
Min 50% draw volume
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.
Interpretation
Seropositivity for 1 or more islet cell autoantibodies is supportive of:
-A diagnosis of type 1 diabetes. Only 2% to 4% of patients with type 1 diabetes are antibody negative; 90% have more than 1 antibody marker, and 70% have 3 or 4 markers.(1) Patients with gestational diabetes who are antibody seropositive are at high risk for diabetes postpartum. Rarely, diabetic children test seronegative, which may indicate a diagnosis of maturity-onset diabetes of the young in clinically suspicious cases.
-A high risk for future development of diabetes. Among 44 first-degree relatives of patients with type 1 diabetes, those with 3 antibodies had a 70% risk of developing type 1 diabetes within 5 years.(2)
-A current or future need for insulin therapy in patients with diabetes. In the UK Prospective Diabetes Study, 84% of those classified clinically as having type 2 diabetes and seropositive for glutamic acid decarboxylase 65 (GAD65) required insulin within 6 years, compared to 14% that were antibody negative.(3)
Cautions
Negative results do not exclude the diagnosis of or future risk for type 1 diabetes mellitus. The risk of developing type 1 diabetes may be stratified further by testing for human leukocyte antigen genetic markers. Careful monitoring of hyperglycemia is the mainstay for determining the requirement for insulin therapy.
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 daysSpecimen Retention Time
28 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterCPT Code Information
86337
86341 x3