| Product Name | GAD65 Antibody - ELISA |
| Catalog-No. | EA104/96 |
| Description | Enzyme Immuno Assay for the Quantitative Determination of Antibodies against Glutamic Acid Decarboxylase in serum |
| Format | 12x8 Determinations, single break apart wells |
| Procedure | The GAD65 Antibody ELISA depends on the ability of GAD autoantibodies to act divalently and form a bridge between GAD coated on ELISA plate wells and liquid phase GAD-biotin. The GAD-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 (0-2,000 units per ml of WHO reference preparation NIBSC 97/550). |
| Clinical Fields | Internal medicine, immunology, endocrinology |
| Diseases | Insulin Dependent Diabetes Mellitus (IDDM) |
| Normal Value | 99% of healthy blood donor sera give values of less than 5 Units per ml (NIBSC 97/550) in the assay suggesting that values of 5 U/ml or greater can be considered positive for GAD autoantibodies. However, a provisional cut off for positivity of 10 Units per ml is recommended until individual laboratories have established their own cut off values using appropriate control sera. |
| Specificity | In the DASP 2005 study the kit achieved 98% (n=100) specificity. |
| Sensitivity | In the DASP 2005 study the kit achieved 92% (n=50) sensitivity. |
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