| Nivolumab

Nivolumab is an anti-cancer medication used to treat a number of types of cancer.This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer.It is administered intravenously.
 

| 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	2.85	2.28	1.58	0.98	0.56	0.33	0.24	0.09
Corrected OD	2.76	2.19	1.49	0.89	0.47	0.24	0.15	-

 

| Repeatability

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

| Recovery

The recovery of HumanNivolumab 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)	84-101	92
Plasma(n=8)	92-106	101
Cell Culture Supernates(n=8)	95-110	98

 

| Linearity

Samples were spiked with high concentrations of HumanNivolumab 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 (%)	91	92	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	92	97	105