Enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of nivolumab (Opdivo®) in serum and plasma. Assay Genie Nivolumab ELISA has been specially developed for the quantitative analysis of free nivolumab in serum and plasma samples at high specificity.

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. Standards and samples (serum or plasma) are incubated in the microtitre plate coated with the reactant for nivolumab (Opdivo®). After incubation, the wells are washed. A horse radish peroxidase (HRP) conjugated probe is added and binds to nivolumab captured by the reactant on the surface of the wells. Following incubation wells are washed and the bound enzymatic activity is detected by addition of chromogen-substrate. The colour developed is proportional to the amount of nivolumab in the sample or standards. Results of samples can be determined directly using the standard curve.

Nivolumab is a fully human IgG4 monoclonal antibody that acts as an immunomodulator by blocking ligand activation of programmed cell death 1 (PD-1) receptor on T cells. Nivolumab binds to the programmed cell death 1 (PD-1) receptor and selectively blocks interaction with its programmed death ligands PD-L1 and PD-L2. Upregulation of PD-1 ligands occurs in some tumors and signalling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumour tissue. The inhibitory effect of PD-1 and its ligands occurs through the promotion of apoptosis in antigen specific T cells while simultaneously blocking apoptosis in suppressor T cells. Blocking PD-1 activity has been shown to lead to decreased tumour growth in mouse tumour models.

Nivolumab (Opdivo®) is indicated for use in patients with unresectable (cannot be surgically removed) or metastatic melanoma who no longer respond to other drugs. It is also used to treat metastatic squamous non-small cell lung cancer and is a second-line treatment for renal cell carcinoma after anti-angiogenic treatment has failed.

Nivolumab is administered as an intravenous infusion over 60 minutes every 2 weeks. Nivolumab is indicated for the treatment of unresectable or metastatic melanoma for patients who no longer respond to treatment with other drugs. It is intended for use in patients who have been previously treated with ipilimumab and is used for melanoma patients after treatment with ipilimumab and a BRAF inhibitor in patients whose tumors express BRAF V600 gene mutations. Historically there have been very few effective treatments for advanced melanoma, which is why this product was approved under an FDA accelerated program to allow earlier patient access.

Opdivo is a registered trademark of Bristol-Myers Squibb Company.