Denosumab ELISA Kit

Sample

Serum, plasma, and cell culture supernatants

Species Reactivity

Human

Intended Use

The Denosumab ELISA is used as an analytical tool for quantitative determination of Denosumab in serum, plasma and cell culture supernatant.

Storage

1. All reagents should be stored at 2°C to 8°C for stability.
2. All the reagents and wash solutions should be used within 12 months from manufacturing date.
3. Before using, bring all components to room temperature (18-25°C). Upon assay completion ensure all components of the kit are returned to appropriate storage conditions.
4. The Substrate is light-sensitive and should be protected from direct sunlight or UV sources.

Precision

Precision is defined as the percent coefficient of variation (%CV) i.e. standard deviation divided by the mean and multiplied by 100. Assay precision was determined by both intra (n=5 assays) and inter assay (n=5 assays) reproducibility on two pools with low (2.5ng/ml), medium (20ng/ml) and high (160ng/ml) concentrations. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.

Detection Limit

It is defined as the lowest detectable concentration corresponding to a signal of Mean of '0' standard plus 2* SD. 10 replicates of '0' standards were evaluated and the LOD was found to be less than 2.5ng/ml

General Description

Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle pain in the arms or legs. Denosumab is a RANKL inhibitor, which works by preventing the development of osteoclasts which are cells that break down bone (bone resorption).