Data Sheet
Human drug specific sub-isotyping – ADA ELISA
Catalogue Number: SB-06-027
Notice: This product specification data sheet is for information purposes only. Please contact tec@somrubioscience.com for up to date information.
Product Specifications Data Sheet
| About | The Somru® drug specific human anti-drug antibody ELISA kit is a multi-detection sandwich assay for the characterization of antibodies against specific drugs in serum and plasma samples. The assay is designed to for semi-quantitative measurement of sub-isotpes of human IgGs (IgG1, IgG2, IgG3, and IgG4) or any subset of them. This is a custom assay designed and produced in consultation with client to meet specific project need. |
| Detection Method | Multi-mode detection method is available. |
| Storage | Store the unopened kit at 2-8 °C. |
| Positive control | Check lot specific Certificate of Analysis (CofA) for details. |
| Precision | Check lot specific Certificate of Analysis (CofA) for details. |
| Sensitivity | Check lot specific Certificate of Analysis (CofA) for details. |
| Drug Tolerance | Check lot specific Certificate of Analysis (CofA) for details. |
| Sample Pre-treatment | Sample pre-treatment process may be utilized to improve drug tolerance and the detection of ADAs in biological samples. For further details, please contact our technical service team at tec@somrubioscience.com. |
| Interpretation of results | The results are reported as positive or negative relative to a pre-determined cutpoint. The cutpoint may be determined in each plate by running 4-10 negative controls. The cutpoint is calculated by calculating the mean of the negative controls and by adding 2*standard deviations to the calculated mean. |
| Safety Warnings and Precautions | All chemicals and biological samples should be considered potentially hazardous and infectious. We recommend that this product and its components be handled by those trained in laboratory techniques and be used according to the principles of Good Laboratory Practice. |
| Statistical cut point | We strongly recommend each lab develop their own statistical cutpoint in the appropriate study population using methodologies as described by G. Shankar, et al. (2008). (Recommendations for the Validation of Immunoassays Used for Detection of Host Antibodies Against Biotechnology Products. J. Pharmaceutical and Biomedical Analysis 48:1267–1281). Please contact our technical service team at tec@somrubioscience.com for details. |
Notice: Somru® ELISA kits are custom-made to order. Each kit lot is tested to ensure that it meets specifications before shipment. Minor adjustments to the preparation of reagents may occur due to lot-to-lot variation. Please always refer to the product sheet enclosed with each kit before performing each experiment.
FOR RESEARCH USE ONLY
