DESCRIPTION

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

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. Dupilumab has been pre-coated onto a microplate. Samples or standards are pipetted into microwells and Anti-Dupilumab will be captured by immobilized Dupilumab. After washing away any unbound substances, a biotin-labeled Dupilumab 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-Dupilumab 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)		59.4	28.7	5.2	63.5	28.9	7.4
Standard deviation		5.5	1.9	0.5	9.4	2.7	1.0
CV \(%\)		9.3	6.7	8.9	14.7	9.4	12.9

RECOVERY

The recovery of Anti-Dupilumab 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	100	90-117
	1:20	98	84-118

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Anti-Dupilumab 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	95	91-100
	1:4	98	91-103
	1:8	96	90-100
	1:16	96	92-101

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)