| Product Name | IA2 Antibody - ELISA |
| Catalog-No. | EA105/96 |
| Description | Enzyme Immuno Assay for the quantitative determination of antibodies against IA-2 in serum |
| Format | 12x8 Determinations |
| Procedure | The IA-2 Antibody ELISA depends on the ability of IA-2 autoantibodies to act divalently and form a bridge between IA-2 coated on ELISA plate wells and liquid phase IA-2-biotin. The IA-2-biotin bound is is then quantitated by addition of streptavidin peroxidase and a colorogenic substrate (TMB) with reading of final absorbance at 2 wavelengths (450 and 405 nm) to obtain maximum measuring range (7.5 - 4,000 units per ml of WHO reference preparation NIBSC 97/550). |
| Clinical Fields | Internal medicine, immunology, endocrinology |
| Diseases | Insulin Dependent Diabetes Mellitus (IDDM) |
| Normal Value | Healthy blood donor sera give values of less than 7.5 Units per ml (NIBSC 97/550) in the assay suggesting that values of 7.5 U/ml or greater can be considered positive for IA-2 autoantibodies. However, individual laboratories should establish their own cut off values using appropriate control sera. |
| Specificity | Results from the DASP 2005 study indicate 99% specificity (n=100). |
| Sensitivity | Results from the DASP 2005 study indicate 66% sensitivity (n=50). |
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