Test Id : FDAIP
Diabetes Autoimmune Profile
Useful For
Suggests clinical disorders or settings where the test may be helpful
Published positivity rates for diabetes autoantibodies in new-onset Type 1 diabetes patients listed below are based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and ZNT8 antibodies. The combined analysis has a 98% autoimmunity detection rate, with 1.8% of Type 1 diabetic individuals remaining as autoantibody-negative.
Positive rate in new-onset type 1 diabetes patients:
GAD-65 antibodies = 68% positive
ICA 512 antibodies = 72% positive
Insulin antibodies = 55% positive
ZnT8 antibodies = 63% positive
An increase in the number of positive antibodies is associated with a higher likelihood of type 1 diabetes.
Less than 3% of Type 2 diabetics have positive antibodies.(1)
Method Name
A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoprecipitation
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Insulin Antibodies
Anti GAD 65 Antibodies
IA-2 Autoantibodies
ZNT8 Antibodies
Type 1 Diabetes
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: Serum gel
Acceptable: Red top
Submission Container/tube: Plastic vial
Specimen Volume: 2.5 mL
Collection Instructions:
1. Centrifuge and aliquot 2.5 mL of serum into a plastic vial.
2. Freeze immediately and send frozen.
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.
1 mL (Note: This volume does not allow for repeat testing)
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Thawing | Cold OK; Warm reject |
| Lipemia | Reject |
| EDTA plasma | 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 | Frozen | 7 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Published positivity rates for diabetes autoantibodies in new-onset Type 1 diabetes patients listed below are based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and ZNT8 antibodies. The combined analysis has a 98% autoimmunity detection rate, with 1.8% of Type 1 diabetic individuals remaining as autoantibody-negative.
Positive rate in new-onset type 1 diabetes patients:
GAD-65 antibodies = 68% positive
ICA 512 antibodies = 72% positive
Insulin antibodies = 55% positive
ZnT8 antibodies = 63% positive
An increase in the number of positive antibodies is associated with a higher likelihood of type 1 diabetes.
Less than 3% of Type 2 diabetics have positive antibodies.(1)
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.
Insulin Antibodies
<5.0 uU/mL: Negative
> or =5.0 uU/mL: Positive
Anti GAD 65 Antibodies
<5.0 U/mL: Negative
> or =5.0 U/mL: Positive
IA-2 Autoantibodies
<7.5 U/mL: Negative
> or =7.5 U/mL: Positive
ZNT8 Antibodies
<15 U/mL: Negative
> or =15 U/mL: Positive
Reference ranges apply to all ages.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Wenzlau JM, Juhl K, Yu L, et al. The cation efflux transporter ZnT8 (Slc30A8) is a major autoantigen in human type 1 diabetes. Proc Natl Acad Sci U S A. 2007;104(43):17040-17045. doi:10.1073/pnas.0705894104
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Varies
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.
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 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.
Insulin Antibodies: This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the 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.
CPT codes are provided by the performing laboratory.
86337
86341x3
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 |
|---|---|---|
| FDAIP | Diabetes Autoimmune Profile | Not Provided |
| 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.
|
|---|---|---|
| Z6377 | Insulin Antibodies | 8072-1 |
| Z6378 | Anti GAD 65 Antibodies | 56540-8 |
| Z6387 | IA-2 Autoantibodies | 31209-0 |
| Z6388 | ZNT8 Antibodies | 76651-9 |
| Z6389 | Type 1 Diabetes Interpretation | 8251-1 |