DESCRIPTION

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

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. Certolizumab has been pre-coated onto a microplate. Samples or standards are pipetted into microwells and Anti-Certolizumab will be captured by immobilized Certolizumab. After washing away any unbound substances, a biotin-labeled Certolizumab 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-Certolizumab 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)		1879.7	407.3	94.0	1841.5	319.0	70.6
Standard deviation		82.6	18.9	9.3	99.4	15.8	6.9
CV \(%\)		4.4	4.6	9.9	5.4	4.9	9.7

RECOVERY

The recovery of Anti-Certolizumab 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=3)	1:10	96	84-105
	1:20	88	82-97

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Anti-Certolizumab 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=4)	1:2	98	96-102
	1:4	101	99-104
	1:8	103	95-108
	1:16	108	93-117

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)