Enzyme-linked immunosorbent assay for the qualitative determination (screening) of anti-Denosumab (Prolia®) antibodies in serum and plasma.The Assay Genie Antibody to Denosumab (Prolia®) ELISA Kit is intended for the qualitative determination of Denosumab anti-drug antibodies (ADA) in serum and plasma. It is for professional use only.

The Assay Genie Antibody to Denosumab (Prolia®) ELISA is a sandwich assay for the determination of anti-Denosumab antibodies in serum and plasma samples. During the first incubation period, antibodies to Denosumab (ATD) in patient serum/ plasma samples are captured by the drug Denosumab (Prolia®) coated on the wall of the microtiter wells. After washing away the unbound components from samples, a peroxidase-labelled specific conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of anti-Denosumab antibodies in sample.

Denosumab (Prolia®) has a mechanism of action unlike other osteoporosis treatments. Administered every six months as a subcutaneous injection, Denosumab (Prolia®) is the only therapy that targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Through highly specific inhibition of RANK ligand, Denosumab (Prolia®) decreases bone resorption, and improves bone density at all measured skeletal sites. Denosumab (Prolia®) is reimbursed for women and men aged 70 or over with a Bone Mineral Density (BMD) T-score of -2.5 or less.

Denosumab (Prolia®) is used for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral, non-vertebral and hip fractures and to increase bone mass in men with osteoporosis at increased risk of fracture.

Denosumab (Prolia®)is a twice-yearly injection under the skin, usually administered by a general practitioner or practice nurse, and works by targeting the cells that break down bone (osteoclasts) thereby making bone less susceptible to osteoporosis-related fractures.

Denosumab binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab (Prolia®) 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.

As with any biologic therapeutic, immunogenicity, in the form of anti-denosumab antibodies can occur. The demonstration of anti-denosumab antibodies during treatment with denosumab (Prolia®) is a major concern. The Assay Genie Anti-Denosumab (Prolia®) ADA Qualitative ELISA Kit can be efficiently used for monitoring anti-denosumab antibodies in biological samples and is for research use only.

Prolia® is a trademark of Amgen Inc.