Sample
Serum, Plasma (EDTA, Heparin)
Intended Use
The Nivolumab ELISA has been especially developed for the quantitative analysis of free nivolumab 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 30 ng/mL
Functional sensitivity (Limit of quantification-LOQ): 30 ng/mL
General Description
Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This molecule was produced entirely on mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. PD-1 is a member of the CD28 T-cell receptor family which makes it be expressed mainly in T-cells, B cells and myeloid cells. PD-1 is upregulated after chronic antigen stimulation and produces a state of T-cell exhaustion. The ligands for PD-1, PD-L1 and PD-L2, are induced by the presence of inflammatory cytokines such as interferon gamma. Tumour studies have shown to express both PD-1 ligands. When PD-L1 and PD-L2 are bound to PD-1, this produces an inhibitory signal in the T cells which interrupts the immune response. Therefore, nivolumab blocks the immune checkpoint PD-1. The strategy behind this mechanism is related to the reduction of the inhibitory signalling and to restore the patient's natural tumour-specific T-cell immune response. The combination of nivolumab and ipilimumab are based on the fact that PD-1 and CTLA-4 checkpoints have nonredundant roles on T-cell modulation.
Citations
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