Test Code DBS1 Diabetes Mellitus Type 1 Evaluation, Serum
Secondary ID
48400Useful 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.
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)
CPT Code Information
86337
86341 x3
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
DBS1 | Diabetes Mellitus Type 1 Evaluation | 104673-9 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
81596 | GAD65 Ab Assay, S | 30347-9 |
89588 | IA-2 Ab, S | 81155-4 |
8666 | Insulin Abs, S | 60463-7 |
34268 | Diabetes Interpretation, S | 69048-7 |
64926 | ZnT8 Ab, S | 76651-9 |