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26222 Diabetes Mellitus Type 1 Eval, Serum (DBS1)

Diabetes Mellitus Type 1 Eval, Serum (DBS1)
Test Code: DBS1SO
Synonyms/Keywords

​Islet Cell autoantibodies

Test Components

​Diabetes Interp

GAD65

Insulin

IA-2

ZnT8

Useful 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

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Red Top Tube (RTT)​Serum Separator Tube (SST)​4.0 mL​2.0 mL
Specimen Stability Information
Specimen TypeTemperatureTime
​Serum​Refrigerated (preferred)​28 days
​Frozen​28 days
​Ambient​72 hours
Rejection Criteria
Gross Hemolysis
​Gross Icterus
Gross Lipemia​
Interference

​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 HLA genetic markers. Careful monitoring of hyperglycemia is the mainstay for determining the requirement for insulin therapy.

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories

GAD65 antibody: Monday through Friday

Insulin antibodies: Monday, Wednesday, Friday

IA-2 antibody: Tuesday, Thursday

Zinc Transporter 8 Antibody: Tuesday, Thursday

​7  to 10 days

​GD65S, INAB, IA2: Radioimmunoassay (RIA)

EZNT8: Enzyme-Linked Immunosorbent Assay

DMEI: Interpretive Comments

Reference Lab
Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories

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

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 required insulin within 6 years, compared to 14% that were antibody negative.(3)

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​86337​1
​86341​3
Synonyms/Keywords

​Islet Cell autoantibodies

Test Components

​Diabetes Interp

GAD65

Insulin

IA-2

ZnT8

Ordering Applications
Ordering ApplicationDescription
​COM​Diabetes Mellitus Eval
​Cerner​Diabetes Mellitus Eval (DBS1)
​Centricity​Diabetes Mellitus Eval (DBS1)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Red Top Tube (RTT)​Serum Separator Tube (SST)​4.0 mL​2.0 mL
Specimen Stability Information
Specimen TypeTemperatureTime
​Serum​Refrigerated (preferred)​28 days
​Frozen​28 days
​Ambient​72 hours
Rejection Criteria
Gross Hemolysis
​Gross Icterus
Gross Lipemia​
Interference

​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 HLA genetic markers. Careful monitoring of hyperglycemia is the mainstay for determining the requirement for insulin therapy.

Useful 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

Test Components

​Diabetes Interp

GAD65

Insulin

IA-2

ZnT8

Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories

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

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 required insulin within 6 years, compared to 14% that were antibody negative.(3)

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories

GAD65 antibody: Monday through Friday

Insulin antibodies: Monday, Wednesday, Friday

IA-2 antibody: Tuesday, Thursday

Zinc Transporter 8 Antibody: Tuesday, Thursday

​7  to 10 days

​GD65S, INAB, IA2: Radioimmunoassay (RIA)

EZNT8: Enzyme-Linked Immunosorbent Assay

DMEI: Interpretive Comments

Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​86337​1
​86341​3
For most current information refer to the Marshfield Laboratory online reference manual.