Test Catalog

Test Id : EZNT8

Zinc Transporter 8 (ZnT8) Antibody, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Highlights

ZnT8 antibody distinguishes type 1 and type 2 diabetes mellitus.

 

ZnT8 antibody identifies relatives of diabetic patients at most risk for developing diabetes.

 

ZnT8 antibody predicts the future need for insulin treatment in adult-onset diabetic patients.

 

ZnT8 antibody predicts the future development of diabetes mellitus in women with gestational diabetes.

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ZnT8 Ab, S

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 2 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<15.0 U/mL

Interpretation
Provides information to assist in interpretation of the test results

Seropositivity for ZnT8 autoantibody (> or =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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Method Description
Describes how the test is performed and provides a method-specific reference

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.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86341

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports