Test Id : INAB
Insulin Antibodies, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Predicting the future development of type 1 diabetes in asymptomatic children, adolescents, and young adults, when used in conjunction with family history, human leukocyte antigen-typing, and other autoantibodies, including glutamic acid decarboxylase (GAD65) and islet cell antigen 2 (IA-2) antibodies
Differential diagnosis of type 1 versus type 2 diabetes
Evaluating diabetics with insulin resistance in patients with established diabetes (type 1 or type 2)
Investigation of hypoglycemia in nondiabetic subjects
Method Name
A short description of the method used to perform the test
Radioimmunoassay (RIA)
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
Anti-Insulin
Human Insulin
INAB (Insulin Antibodies)
Insulin Ab
Insulin Antibody
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
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 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.
1 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 | |
| Ambient | 72 hours | ||
| Frozen | 28 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Predicting the future development of type 1 diabetes in asymptomatic children, adolescents, and young adults, when used in conjunction with family history, human leukocyte antigen-typing, and other autoantibodies, including glutamic acid decarboxylase (GAD65) and islet cell antigen 2 (IA-2) antibodies
Differential diagnosis of type 1 versus type 2 diabetes
Evaluating diabetics with insulin resistance in patients with established diabetes (type 1 or type 2)
Investigation of hypoglycemia in nondiabetic subjects
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The onset of autoimmune diabetes mellitus (type 1 diabetes mellitus) is preceded (and accompanied) by the appearance of autoantibodies to a variety of pancreatic islet cell antigens in serum, including insulin. The level of these autoantibodies is generally low and may even fall during follow-up. In genetically predisposed, but disease-free, individuals (first degree relatives of patients with type 1 diabetes or individuals with permissive human leukocyte antigen [HLA] alleles), detection of multiple islet cell autoantibodies is a strong predictor for subsequent development of type I diabetes.
Once type 1 diabetes has fully manifested, insulin autoantibody levels usually fall to low or undetectable levels. However, after insulin therapy is initiated, autoantibody production may recur as a memory response. Insulin autoantibody production is more common when therapeutic insulin of animal origin is used (rarely used in contemporary practice). Larger therapeutic doses may be required because of antibody-induced insulin resistance.
Insulin antibodies may be found in nondiabetic individuals complaining of hypoglycemic attacks. In this setting their presence can be an indicator of "factitious hypoglycemia" due to the surreptitious injection of insulin, rather than to a clinical problem (eg, insulinoma). However, insulin autoantibodies in nondiabetic subjects can occasionally develop without exposure to exogenous insulin and may rarely become a cause of episodic hypoglycemia. Anti-idiotypic autoantibodies against insulin autoantibodies have been demonstrated in some cases. Interaction of these antibodies with insulin autoantibodies could displace bound insulin from the insulin autoantibodies, resulting in hypoglycemia.
In addition to IgG and IgM insulin autoantibodies, IgE antibodies (identified by the fluorescence enzyme immunoassay) may occur. IgE insulin autoantibodies result in immediate hypersensitivity reactions, such as urticaria, but do not lead to insulin resistance or hypoglycemia as can be seen with the IgG antibodies. This test only determines the presence of IgG and IgM antibodies, not IgE antibodies.
In conjunction with family history, HLA-typing and measurement of other islet cell autoantibodies (glutamic acid decarboxylase [GAD65] antibody and islet cell antigen 2 antibody [IA-2]), insulin autoantibody testing helps predict the future development of type I diabetes in asymptomatic children, adolescents, and young adults. Inclusion of a recently described fourth autoantibody (zinc transporter 8: ZnT8) further enhances the prediction of type 1 diabetes occurrence and its distinction from type 2 diabetes.
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.
< or =0.02 nmol/L
Reference values apply to all ages
Interpretation
Provides information to assist in interpretation of the test results
Seropositivity (> or =0.03 nmol/L) in a patient never treated with insulin is consistent with predisposition to type 1 diabetes. Seropositivity is not as informative of type 2 diabetes status as other islet cell antibodies in patients who are receiving (or have received) insulin therapy because this antibody can arise secondary to therapy. It is thought that high levels of insulin autoantibodies might contribute to insulin resistance.
A family history of type 1 diabetes, other organ-specific autoimmunity and a diabetes-permissive human leukocyte antigen phenotype strengthens the prediction of type 1 diabetes development. The detection of multiple islet cell antibodies is indicative of the likely development of future type 1 diabetes.
In patients presenting with hypoglycemia, the presence of insulin autoantibodies may indicate surreptitious insulin administration or, rarely, insulin autoantibody-related hypoglycemia. The differential diagnosis cannot be made on the basis of insulin autoantibody detection alone. C-peptide and insulin measurements are always required in addition to insulin autoantibody measurements in the diagnosis of hypoglycemia.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test should not be requested in patients who have recently
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Schernthaner G. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care. 1993;16 Suppl3:155-165
2. Lernmark A. Type 1 diabetes. Clin Chem. 1999;45(8 Pt 2):1331-1338
3. Eisenbarth GS, Jeffery J. The natural history of type 1A diabetes. Arq Bras Endocrinol Metabol. 2008;52(2):146-155
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
(125)I-labeled recombinant human insulin 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 Insulin-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)
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.
Wednesday
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
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.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.
CPT codes are provided by the performing laboratory.
86337
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 |
|---|---|---|
| INAB | Insulin Abs, S | 60463-7 |
| 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.
|
|---|---|---|
| 8666 | Insulin Abs, S | 60463-7 |