Insulin Ab ELISA Kit


Human insulin antibody ELISA kit is a protocol for analysing in-vitro quantitative levels of IgG antibodies to insulin (anti-insulin IgG, insulin Ab, anti-insulin) in human serum and plasma. This assay has a minimum analytical sensitivity limit of 0.5 U/ml.

Mixture of highly purified preparations of porcine, bovine and recombinant human insulin are bound to the microwells.


Diabetes-related auto-antibodies are found to be linked to type 1 diabetes and this is a condition which is characterised by limited or in some cases fully missing secretion of insulin. Many morphological investigations have demonstrated that this process reflects the destruction of beta cells, leading to the loss of beta cell function and thereby causing inadequate production of insulin. This is a feature of type 1 diabetes but it is thought not to be the cause of it.

The detection of anti-insulin auto-antibodies may not be possible until after several months or in some rare cases many years following the onset of a full clinical manifestation of the diseases. These auto-antibodies are causing insulin depot formation which is able to simulate a resistance against any animal insulin hormonal treatment. IgG antibodies are the most common while IgE antibodies have been found to result in causing insulin antibody allergy, at high titers, IgG antibodies are able to limit insulin action that may diminish or delay action of insulin. The development of antibodies is largely dependent of the molecular structure, purity and storage conditions of the insulin administered as well as patient factors (such as age, HLA type, delivery route). Four common diabetes-related autoantibody tests include: Insulin Auto-antibodies (IAA), Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulinoma-Associated-2 Autoantibodies (IA-2A) and Islet Cell Cytoplasmic Autoantibodies (ICA).


All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Divisible Microplate (consisting of 12 modules of 8 wells): highly purified mixture of bovine, porcine and recombinant human insulin is bound to microwells.
  • Calibrator A-F: Concentrations 0, 6.3, 12.5, 25, 50, 100 U/ml, made up from anti-insulin antibodies in a serum/buffer matrix.
  • Control Positive and Control Negative: Containing human anti-insulin antibody.
  • Sample Buffer P (5x).
  • Enzyme Conjugate: Contains anti-human IgG antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution.
  • Wash Buffer (50x).
  • Instruction For Use.
  • Certificate Of Analysis.


The minimum detection sensitivity level of IgG antibodies directed against human anti-insulin (insulin Ab, anti-insulin IgG) using current insulin antibody ELISA kit was 0.5 U/ml. The dynamic range for this assay is 6.3 – 100.0 U/ml.


– Insulin Antibody: ELISA
– Measuring Range: 0 – 100 U/ml
– Expected Values: Cut-Off 10 U/ml
– Results Interpretation: Negative: < 10 U/ml, Positive: ≥ 10 U/ml
– Linearity: 84 – 109%
– Limit Of Detection (LOD): 0.5 U/ml
– Intra Assay Precision: 2.5 – 4.0%
– Inter Assay Precision: 4.3 – 6.0%
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (72.0%), Specificity (98.8%), Overall agreement (88.5%).


  1. The anti-insulin trimolecular complex in type 1 diabetes. Curr Opin Endocrinol Diabetes Obes. (2010) 17 (4): 329-34. Review. Michels A.W. and Nakayama M.
  2. Clinical significance of insulin antibodies in insulin-treated diabetic patients. Diabetes Care. (1989) 12 (9): 641-8. Review. Van Haeften T.W.
  3. Autoimmune insulin syndrome. Biomed Pharmacother. (1989) 43 (8): 581-6. Review. Archambeaud-Mouveroux F., et al.
  4. Insulin assays: previously known and new analytical features. Clin Lab. (2003) 49 (3-4): 113-21. Review. Sapin R.
  5. Role of insulin in glucose-stimulated insulin secretion in beta cells. Curr Diabetes Rev. (2005) 1 (3): 309-30. Review. Goren H.J.
  6. Allergic reactions to human insulin: a review of current knowledge and treatment options. Endocrine. (2010) 37 (1): 33-9. Review. Akinci B., et al.


  • Full Name: Insulin Ab ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 0.5 U/ml



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L. Johnston
PhD Student / University of Glasgow

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Dr. P. Anderson
Lecturer / University College London (UCL)

I am a first time user and found that your instruction manual was very easy to follow. The insulin ELISA assay performed well and I was happy with the results that were generated.

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Senior Technician / Addenbrooke’s Hospital

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Lead Scientists / AstraZeneca

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Purchasing / University of Oxford