Anti-IA2 ELISA Kit (Anti Insulinoma Associated 2)

INTENDED USE

Human anti-IA2 ELISA kit is a reliable quantitative procedure for measuring insulinoma associated 2 (anti-IA2) in human serum samples. This assay has a minimum sensitivity detection limit of 0.95 u/ml.

BACKGROUND

Insulinoma associated 2 (anti-IA2) autoantibodies are found to be highly present in individuals that are in the pre-diabetic phase or those with new-onset type 1 diabetes. There is a direct correlation with the rapid progression to overt type 1 diabetes with the presence of autoantibodies to anti-IA2. It is a member of the tyrosine phosphatases protein family and shares sequence homology with the islet cell antigen 512.

Found to be localised in the second defined recombinant islet cell antigen and the dense granules of pancreatic beta cells and the second defined recombinant islet cell antigen. The higher frequency can be explained by the presence of autoantibodies which are directed to the COOH terminus are lacking in the ICA512 molecule.

A combination of anti-IA2 autoantibodies and GAD65 assay is a highly relevant approach for assessing diabetes (type 1) in children and adolescence. It is possible to detect more than 90% of individuals that are at risk to diabetes (type 1) by performing a screen.

CONTENT

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.

• Coated Microwells: 12 breakapart strips of 8 wells (96 in total) bound with anti-IA-2.
• Calibrators 1-5: Concentrations 7.5, 35, 120, 350, 4000 u/ml (units are NIBSC 97/550).
• Control 1 (Positive) And Control 2 (Negative).
• Reaction Enhancer.
• Wash Solution (10x Concentrated).
• IA-2 Biotin (Lyophilised).
• Reconstitution Buffer.
• Streptavidin Peroxidase (SA-POD).
• Diluent for SA-POD.
• Peroxidase Substrate (TMB).
• Stop Solution.

SENSITIVITY

The minimum sensitivity detection limit of human insulinoma associated 2 (anti-IA2) using current anti-IA2 ELISA kit was approximately 1.25 u/ml. The dynamic range for this assay is 7.5 – 4000.0 u/ml.

ASSAY CHARACTERISTICS

– Assay Cut Off: Negative (< 7.5 u/mL), Positive (> 7.5 u/mL).
– Lower Detection Limit: 0.95 u/mL.
– Clinical Specificity And Sensitivity: In the IASP 2016 study, showed 98% (n=90) specificity and 76% (n=50) sensitivity.
– Intra-Assay Precision: 4.2 – 4.5%
– Inter-Assay Precision: 1.3 – 3.1%
– Interference: None

REFERENCES

1. Lack of anti-insulin, anti-GAD, and anti-IA2 autoantibodies in primary antiphospholipid syndrome. Rheumatol Int. (2012) 32 (5): 1479-80. de Carvalho J.F. and Caleiro M.T.
2. Prevalence of type 1 diabetes autoantibodies (GADA, IA2, and IAA) in overweight and obese children. Diabetes Care. (2010) 33 (4): 820-2. Cambuli V.M., et al.

ADDITIONAL INFORMATION

• Full Name: Anti-IA2 ELISA Kit (Anti Insulinoma Associated 2)
• Reactivity: Human
• Sample Type: Serum
• Sensitivity: 0.95 u/ml

OTHER RELATED ELISA KITS

• Anti-GAD ELISA Kit
• GLP-1 Active ELISA Kit
• Proinsulin ELISA Kit