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Test ID: 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, S

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 2 mL


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

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

Clinical Reference

1. Bingley PJ: Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab 2010;95:25-33

2. Andersson C, Vaziri-Sani F, Delli A, et al: Triple specificity of ZnT8 autoantibodies in relation to HLA and other islet autoantibodies in childhood and adolescent type 1 diabetes. Pediatr Diabetes 2013;14:97-105

3. Dereke J, Nilsson C, Landin-Olsson M, Hillman M: Prevalence of zinc transporter 8 antibodies in gestational diabetes mellitus. Diabet Med 2012;29:e436-439

4. Gorus FK, Balti EV, Vermeulen I, et al: Screening for insulinoma antigen 2 and zinc transporter 8 autoantibodies: a cost-effective and age-independent strategy to identify rapid progressors to clinical onset among relatives of type 1 diabetic patients. Clin Exp Immunol 2013;171:82-90

5. Petruzelkova L, Ananieva-Jordanova R, Vcelakova J, et al:  The dynamic changes of zinc transporter 8 autoantibodies in Czech children from the onset of Type 1 diabetes mellitus. Diabet Med 2014;31:165-171

Day(s) and Time(s) Performed

Tuesday, Thursday, 10 a.m.

Analytic Time

3 days

Test 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 U.S. 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
Mayo Clinic Laboratories | Endocrinology Catalog Additional Information:

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