DESCRIPTION

Used for the quantitative determination of Anti-Ustekinumab concentration in serum and plasma.

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. Ustekinumab has been pre-coated onto a microplate. Samples or standards are pipetted into microwells and Anti-Ustekinumab will be captured by immobilized Ustekinumab. After washing away any unbound substances, a biotin-labeled Ustekinumab is added to the wells. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of Anti-Ustekinumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

PRECISION

Intra-Assay Precision (Precision within an assay): <10% Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision. Inter-Assay Precision (Precision between assays): <15% Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

Sample		1	2	3	1	2	3
n		16	16	16	24	24	24
Mean (ng/mL)		46.2	11.5	2.7	45.3	11.3	3.2
Standard deviation		2.0	0.2	0.1	1.5	0.6	0.4
CV \(%\)		4.4	1.6	2.6	3.3	5.0	12.8

RECOVERY

The recovery of Anti-Ustekinumab spiked to three different levels in human serum samples throughout the range of the assay was evaluated.

Sample	Dilution factor	Average (%)	Range (%)
Human serum (n=4)	1:10	93	80-106
	1:20	85	80-94

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Anti-Ustekinumab and diluted with the Standard Diluent to produce samples with values within the dynamic range of the assay.

Sample	Dilution factor	Average (%)	Range (%)
Human serum (n=3)	1:2	93	88-102
	1:4	97	91-106
	1:8	100	93-109
	1:16	95	84-107

Ordering & shipping

• Minimum order: 1 kit
• Lead time: varies with order quantity and specifications. Please consult your local distributor or our sales team for confirmation
• Payment: T/T 100% in advance; PayPal; Alibaba Trade Assurance
• Shipping: FedEx / DHL / UPS express; cold-chain packing available on request
• Price: USD, per kit (48T / 96T options available)