Data Sheet
Nivolumab (Opdivo®) – ADA ELISA
Catalogue Number: SB-06-076
For the qualitative determination of antibodies to Nivolumab 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 method utilizes solid phase extraction with acid dissociation to detect anti-Nivolumab antibodies with high sensitivity in presence of drug. The data is generated using a colorimetric ELISA. The method can be adapted to ECL format to improve sensitivity and drug tolerance. |
| Detection Method | Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm. |
| Storage | Kit ships at 2-8 °C. Multiple storage temperatures upon arrival. |
| Positive Control | Affinity purified Rabbit anti-Nivolumab antibody |
| Sensitivity | Detection Limit of 64 ng/mL. |
| Drug Tolerance | 100 µg/mL. |
| Precision | Intra-assay precision ranges from 3 to 7%. Inter-assay mean precision is 12%. Determined by analysis of samples at 100 ng/mL in 6 replicates, on 6 different occasions. |
| Interpretation of Results | Results are reported as positive or negative relative to a pre-determined cutpoint. |
| Statistical CutPoint | 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). For further details please contact tec@somrubioscience.com. |
| Safety Warnings and Precautions | All reagents and samples should be handled as if potentially hazardous and infectious. It is recommended that all kit reagents are handled by trained laboratory staff and are used in accordance with GLP. |
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
