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Insulin Antibody Type I & II diabetes serum
Diabetes
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Autoantibodies to insulin.
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Insulin Antibody Type I & II Diabetes Serum - Comprehensive Test Guide
- Why is it done?
- Test Purpose: This test detects insulin antibodies (also called insulin autoantibodies) in serum blood samples. It identifies the presence of autoimmune reactions against insulin and insulin-producing beta cells in the pancreas.
- Early Detection of Type 1 Diabetes: Identifies individuals at high risk for developing Type 1 diabetes, including those with a family history of autoimmune diabetes or other autoimmune conditions.
- Differential Diagnosis: Distinguishes Type 1 diabetes (autoimmune) from Type 2 diabetes (metabolic) in newly diagnosed diabetic patients, particularly in children and young adults.
- Latent Autoimmune Diabetes in Adults (LADA): Identifies patients with LADA, who are initially misdiagnosed with Type 2 diabetes but have autoimmune destruction of beta cells.
- Screening of Relatives: Used to screen first-degree relatives of Type 1 diabetic patients to identify those at risk before symptom onset.
- Monitoring Progression: Assists in monitoring disease progression and beta cell destruction in at-risk individuals.
- Normal Range
- Negative Result (Normal): Less than 0.4 units/mL or negative antibody index This indicates the absence of detectable insulin antibodies and suggests no autoimmune attack on insulin-producing cells.
- Borderline/Weakly Positive: 0.4 to 0.9 units/mL Values in this range suggest possible early or low-level autoimmune response; repeat testing may be recommended.
- Positive Result (Abnormal): Greater than 0.9 units/mL or positive antibody index Indicates the presence of insulin autoantibodies and suggests autoimmune-mediated beta cell destruction.
- Units of Measurement: Results are typically reported in units/mL (international units per milliliter) or as an antibody index with a cutoff value.
- Interpretation Note: Reference ranges may vary between laboratories and test methodologies used (ELISA, immunoprecipitation, or radiobinding assay).
- Interpretation
- Negative Result: Indicates low risk for autoimmune diabetes development; Type 1 diabetes is unlikely. Patient likely has Type 2 diabetes if diabetic symptoms are present.
- Positive Result (Single Antibody): Suggests early-stage autoimmune process; significantly increases risk for Type 1 diabetes development. Multiple antibody detection (GAD65, IA-2, ZnT8) may be needed for confirmation.
- Positive Result (Multiple Antibodies): Strongly diagnostic for Type 1 diabetes or impending Type 1 diabetes; indicates active beta cell autoimmunity. High risk for symptomatic disease within months to years.
- Clinical Significance Patterns:
- High antibody levels with low C-peptide: Indicates advanced beta cell destruction and imminent or established Type 1 diabetes.
- Positive antibodies with normal glucose levels: Suggests preclinical autoimmunity; lifestyle modifications and close monitoring are recommended.
- Factors Affecting Results:
- Infection or vaccination: May transiently affect antibody levels; retest after 4-6 weeks if indicated.
- Exogenous insulin therapy: Chronic insulin administration may produce anti-insulin antibodies but differs from native insulin autoantibodies.
- Laboratory methodology: Different assay techniques may produce variable results; consistency in testing methodology is important.
- Hemolysis or lipemia: May interfere with test accuracy; proper specimen collection and handling is essential.
- Associated Organs
- Primary Organ System: Pancreas (specifically pancreatic islet beta cells) and endocrine system.
- Type 1 Diabetes Mellitus: Autoimmune destruction of insulin-producing beta cells in pancreatic islets (Islets of Langerhans), leading to absolute insulin deficiency.
- Latent Autoimmune Diabetes in Adults (LADA): Slow-progressing autoimmune diabetes occurring in adults; combines features of Type 1 and Type 2 diabetes.
- Associated Autoimmune Conditions:
- Thyroid disease (autoimmune thyroiditis): Thyroid antibodies often co-occur with insulin antibodies.
- Celiac disease: Increased prevalence in Type 1 diabetic patients with autoimmune features.
- Addison's disease: Other organ-specific autoimmune disorders frequently present with Type 1 diabetes.
- Graves' disease: Thyroid autoimmunity commonly associated with insulin autoimmunity.
- Complications from Abnormal Results:
- Diabetic ketoacidosis (DKA): Acute life-threatening complication from rapid beta cell destruction in Type 1 diabetes.
- Hyperglycemia: Elevated blood glucose from insufficient insulin production.
- Microvascular complications: Retinopathy, nephropathy, neuropathy from prolonged hyperglycemia.
- Macrovascular complications: Coronary artery disease, stroke, peripheral vascular disease.
- Follow-up Tests
- Other Autoimmune Diabetes Markers (if insulin antibody positive):
- GAD65 Antibody (Glutamic Acid Decarboxylase): Detects antibodies against GAD65 enzyme; positive in majority of Type 1 diabetics.
- IA-2 Antibody (Islet Antigen-2): Identifies antibodies to tyrosine phosphatase; strong indicator of autoimmune diabetes.
- ZnT8 Antibody (Zinc Transporter 8): Detects antibodies to zinc transporter protein; increasingly recognized as important diabetes autoimmune marker.
- Glucose Metabolism Tests:
- Fasting Blood Glucose: Establishes baseline glucose levels and diabetes diagnosis criteria.
- Hemoglobin A1c (HbA1c): Measures average blood glucose control over 2-3 months; essential for diagnosis and monitoring.
- Oral Glucose Tolerance Test (OGTT): Evaluates pancreatic function and insulin secretion in response to glucose challenge.
- Beta Cell Function Assessment:
- C-Peptide Level: Measures residual beta cell function; critical for prognosis and treatment planning.
- Stimulated C-Peptide: MIXED-meal or glucagon stimulation test to assess remaining beta cell capacity.
- Associated Autoimmune Screening:
- Thyroid Peroxidase (TPO) Antibody: Screens for autoimmune thyroid disease commonly associated with Type 1 diabetes.
- TSH and Free T4: Evaluates thyroid function in diabetic patients with autoimmune markers.
- Tissue Transglutaminase (tTG) IgA: Screening for celiac disease, increased in Type 1 diabetics.
- Monitoring Frequency for At-Risk Individuals:
- Single positive antibody: Annual testing or as clinically indicated.
- Multiple positive antibodies: Every 3-6 months with glucose tolerance testing.
- Metabolic Profiling:
- Lipid Panel: Baseline lipid assessment important for cardiovascular risk stratification in diabetics.
- Kidney Function Tests (BUN, Creatinine, eGFR): Monitors renal function as diabetes complication screening.
- Urine Microalbumin: Screens for early diabetic nephropathy.
- Fasting Required?
- Answer: No Fasting is NOT required for insulin antibody testing.
- Sample Collection:
- Blood can be drawn at any time of day regardless of food intake.
- Serum separator tube (SST) or standard blood collection tube is used.
- No special processing or immediate separation required unless specified by laboratory.
- Special Instructions:
- No medications need to be discontinued specifically for this test.
- Inform healthcare provider of all current medications, as some may be relevant to clinical interpretation.
- Avoid hemolysis during collection; inform phlebotomist if using any blood thinners like warfarin or aspirin.
- Timing Considerations:
- Antibody levels are stable and not affected by time of day or recent meals.
- If concurrent glucose testing is needed, morning fasting blood draw may be requested for that component.
- Results typically available within 1-5 business days depending on laboratory.
How our test process works!

