Test Catalog

Test Id : DBS1

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Diabetes Mellitus Type 1 Evaluation, Serum

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Overview

Test Catalog

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

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

Highlights

This evaluation consisting of tests for 4 antibodies targeting islet cell antigens (GAD65, IA-2, ZnT8, and insulin) gives optimum sensitivity and specificity for the diagnosis of type 1 diabetes mellitus.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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
A short description of the method used to perform the test

GD65S, INAB, IA2: Radioimmunoassay (RIA)

EZNT8: Enzyme-Linked Immunosorbent Assay (ELISA)

DMEI: Interpretive Comments

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

Diabetes Mellitus Type 1 Evaluation

Aliases
Lists additional common names for a test, as an aid in searching

Islet cell autoantibodies

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

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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

2 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

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

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

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. 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
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.

GLUTAMIC ACID DECARBOXYLASE (GAD65) ANTIBODY

< or =0.02 nmol/L

Reference values apply to all ages.

 

INSULIN ANTIBODIES

< or =0.02 nmol/L

Reference values apply to all ages.

 

ISLET ANTIGEN 2 (IA-2) ANTIBODY

< or =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
Provides information to assist in interpretation of the test results

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
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 human leukocyte antigen genetic markers. Careful monitoring of hyperglycemia is the mainstay for 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(1):25-33

2. Bingley PJ, Gale EA. Progression to type 1 diabetes in islet cell antibody-positive relatives in the European Nicotinamide Diabetes Intervention Trial: the role of additional immune, genetic and metabolic markers of risk. Diabetologia. 2006;49(5):881-890

3. Turner R, Stratton I, Horton V, et al. UKPDS 25: autoantibodies to islet-cell cytoplasm and glutamic acid decarboxylase for prediction of insulin requirement in type 2 diabetes. UK Prospective Diabetes Study Group. Lancet. 1997;350(9087):1288-1293

4. Thomas NJ, Jones AG. The challenges of identifying and studying type 1 diabetes in adults [published online ahead of print, 2023 Sep 20]. Diabetologia. 2023;10.1007/s00125-023-06004-4. doi:10.1007/s00125-023-06004-4

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

Radioimmunoassay:

(125)I-labeled recombinant human antigen is incubated with patient sample. Anti-human IgG is then added to form an immunoprecipitate. After washing the immunoprecipitate, the amount of (125)I-labeled antigen in the immunoprecipitate is measured using a gamma-counter. The amount of gamma emission in the precipitate is proportional to the amount of antigen-specific IgG in the sample. Results are reported as units of precipitated antigen (nMol) per L of patient sample.(Masuda M, Powell M, Chen S, et al. Autoantibodies to IA-2 in insulin-dependent diabetes mellitus. Measurements with a new immunoprecipitation assay. Clin Chim Acta. 2000;291(1):53-66; Walikonis JE, Lennon VA. Radioimmunoassay for glutamic acid decarboxylase [GAD65] autoantibodies as a diagnostic aid for stiff-man syndrome and a correlate of susceptibility to type 1 diabetes mellitus. Mayo Clin Proc. 1998;73[12]:1161-1166; Horta ES, Lennon VA, Lachance DH, et al. Neural autoantibody clusters aid diagnosis of cancer. Clin Cancer Res. 2014;20[14]:3862-9386)

 

Enzyme-Linked Immunosorbent Assay

Zinc transporter 8 (ZnT8) antibodies are principally directed against the C terminal domain of ZnT8. The ZnT8 autoantibody enzyme-linked immunosorbent assay 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 samples in duplicate are added to ZnT8 coated plate wells and incubated overnight. ZnT8-biotin is added to each well and plates. After further incubation, aspiration, and wash, streptavidin-peroxidase is added to each well. After further incubation, aspiration, and wash, peroxidase substrate is added. After further incubation, 0.5 mol/L sulfuric acid stop solution is added to each well. Absorbance is measured at 450nm, blanked against wells containing peroxidase substrate and sulfuric acid only.(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(2):165-171)

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.

GAD65 antibody: Monday through Friday

Insulin antibodies: Monday, Wednesday, Friday

IA-2 antibody, Zinc Transporter 8 Antibody: 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.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

28 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.

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  • Prospective clients should contact their account representative. 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.

See Individual Test IDs

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.

86337

86341 x3

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
DBS1 Diabetes Mellitus Type 1 Evaluation 104673-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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

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

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2023-02-01
Test Status - Test Delay 2023-01-17
Test Status - Test Resumed 2022-12-16
Test Status - Test Delay 2022-11-23