Data Sheet
Denosumab (Prolia®) – ADA ELISA
Catalogue Number: SB-06-064
For the quantitative determination of Denosumab 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® denosumab ELISA kit is designed to measure anti-denosumab with high specificity and enhanced sensitivity in serum or plasma. This user-friendly assay design utilizes streptavidin to capture the anti-denosumab in a solution phase containing biotinylated denosumab, and an anti-digoxigenin antibody for detection. |
| Detection Method | Colourmetric; absorbance at 450 nm with a reference at 650nm. |
| Storage | Kit ships at 2 to 8°C. Multiple storage temperatures upon arrival. |
| Positive Control | Rabbit anti-adalimumab. |
| Sensitivity | Detection limit of 50 ng/mL. |
| Drug Tolerance | Tolerance up to 20 ng/mL. |
| Sample Pre-Treatment | Drug tolerance can be improved with acid dissociation. For further details please contact tec@somrubioscience.com. |
| Precision | Intra-assay precision ranges from 2 to 7%. Inter-assay mean precision is 4%. Determined by analysis of samples at 100 ng/mL in 6 replicates, on 6 different occasions. |
| Rheumatoid Factor (RF) Interference | If high levels are RF are expected, a sample pre-treatment step may be incorporated into the assay. For further details please contact tec@somrubioscience.com. |
| Interpretation of Results | Results are reported as positive or negative relative to a pre-determined cutpoint. To determine the cutpoint, run 4-10 negative controls and calculate their mean, then add 2* standard deviations to the calculated mean. |
| 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
