| Denosumab

Denosumab is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.Denosumab is an inhibitor of RANKL (receptor activator of nuclear factor kappa-Β ligand),which works by decreasing the development of osteoclasts, which are cells that break down bone. Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption.Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (ng/mL)	50	25	12.5	6.25	3.12	1.56	0.78	0
OD	2	1.56	1.14	0.76	0.49	0.33	0.24	0.1
Corrected OD	1.9	1.46	1.04	0.66	0.39	0.23	0.14	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of HumanDenosumab spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-108	90
Plasma(n=8)	92-106	97
Cell Culture Supernates(n=8)	95-110	98

 

| Linearity

Samples were spiked with high concentrations of HumanDenosumab and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-98	88-96	90-110
	Average (%)	92	91	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	96	93	105