Data Sheet
Rituximab (Rituxan®, Mabthera®) ADA ELISA
Catalogue Number: SB-06-022
For the quantitative determination of Etanercept in human serum and plasma
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® Rituximab ELISA kit is a double antigen sandwich assay for the determination of antibodies against rituximab in serum and plasma samples. Our ELISA-based kits combine a fast, user-friendly format with a sensitive and specific assay. This assay is capable of detecting all isotypes of anti-rituximab antibodies. |
| Detection Method | Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm. |
| Storage | Store the unopened kit at 2-8 °C. |
| 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. |
| Positive control | Chicken anti-rituximab antibodies fortified in human serum. Check lot specific Certificate of Analysis (CofA) for details. |
| Precision | The precision was determined by analyzing samples prepared at 500 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 4% to 12%. Inter-assay mean precision was at 10%. |
| Sensitivity | The detection limit is 11 -124 ng/mL depending on the positive control used. |
| Drug Tolerance | The drug tolerance is up to 6.8 µg/mL. |
| Sample Pre-treatment | An acid dissociation step is recommended 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. |
| 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). |
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
