Sample
Serum, Plasma (EDTA, Heparin)
Intended Use
Enzyme immunoassay for determination of quantitative antibodies to Denosumab in serum and plasma samples.
Storage
The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight. The strips of microtiter plate are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2-8°C.
Precision
Intra-assay and inter-assay CVs < 30%
Sensitivity
The lowest detectable level (Lowest detection limit, LOD) that can be distinguished from the zero standard is 18.75 ng/mL
Functional sensitivity (Limit of quantification-LOQ): 31.25 ng/mL
General Description
Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated inmultiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulphides. Denosumab is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal/resorption. In many bone losses, RANKL overwhelms the body's natural defense against bone destruction. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
Citations
Publication ()
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