| Ustekinumab

Ustekinumab is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,targeting both IL-12 and IL-23.It is administered either by intravenous infusion or subcutaneous injection.The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.
 

| 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	2.72	1.63	0.9	0.54	0.35	0.27	0.22	0.08
Corrected OD	2.64	1.55	0.82	0.46	0.27	0.19	0.14	-

 

| Repeatability

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

| Recovery

The recovery of HumanUstekinumab 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)	84-104	94
Plasma(n=8)	92-105	96
Cell Culture Supernates(n=8)	95-110	98

 

| Linearity

Samples were spiked with high concentrations of HumanUstekinumab 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	92	95
1 : 4	Range (%)	89-102	87-108	105-115
	Average (%)	90	91	105