Test Code EZNT8 Zinc Transporter 8 (ZnT8) Antibody, Serum
Useful For
Clinical distinction of type 1 from type 2 diabetes mellitus
Identification of individuals at risk of type 1 diabetes (including high-risk relatives of patients with diabetes, and those with gestational diabetes)
Prediction of future need for insulin treatment in adult-onset diabetic patients
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
ZnT8 Ab, SSpecimen Type
SerumSpecimen Required
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
1 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 | OK |
Gross lipemia | OK |
Gross icterus | OK |
Clinical Information
Islet cell autoantibodies have been known to be associated with type 1 diabetes mellitus since the 1970s.(1) 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. 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. Because of symptom-onset in adulthood, societal obesity, and initial insulin-independence, some patients with type 1 diabetes are initially diagnosed as having type 2 diabetes,. 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.(2-5) Patients with gestational diabetes can also be stratified for future diabetes risk by detection of 1 or more islet autoantibodies (including ZnT8 antibody).
Reference Values
<15.0 U/mL
Interpretation
Seropositivity for ZnT8 autoantibody (≥15 IU/mL) is supportive of:
-A diagnosis of type 1 diabetes
-A high risk for future development of diabetes
-A current or future need for insulin therapy in patients with diabetes
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: 1) antibodies targeting insulin, IA2, and GAD65 and 2) HLA genetic markers. Careful monitoring of hyperglycemia is the mainstay of determining the requirement for insulin therapy
Method Description
Zinc Transporter 8 (ZnT8) antibodies are principally directed against the C terminal domain of ZnT8. The ZnT8 autoantibody ELISA is based on the bridging principle that employs the ability of divalent ZnT8 autoantibodies to bind to ZnT8 coated on to the plate well with one arm, and to liquid ZnT8-biotin with the other arm. Calibrators or undiluted serum samples in duplicate are added to ZnT- coated plate wells and incubated overnight. ZnT8-biotin is added to each well and plate. After another incubation, aspiration, and wash, streptavidin-peroxidase is added to each well. Another incubation, aspiration, and wash are performed and peroxidase substrate is added. After a final incubation, 0.5 mol/L H2S04 stop solution is added to each well. Absorbance is measured at 450 nm, blanked against wells containing peroxidase substrate and H2S04 only.
Day(s) Performed
Tuesday, Thursday
Report Available
3 to 7 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
86341
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
EZNT8 | ZnT8 Ab, S | 76651-9 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
64926 | ZnT8 Ab, S | 76651-9 |