DESCRIPTION

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

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. Durvalumab has been pre-coated onto a microplate. Samples or standards are pipetted into microwells and Anti-Durvalumab will be captured by immobilized Durvalumab. After washing away any unbound substances, a biotin-labeled Durvalumab 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-Durvalumab 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)		22.5	5.6	1.3	21.9	5.8	1.9
Standard deviation		1.7	0.3	0.1	2.4	0.3	0.3
CV \(%\)		7.5	4.6	5.9	11.1	6.0	13.1

RECOVERY

The recovery of Anti-Durvalumab 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	93	82-120
	1:20	94	80-108

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Anti-Durvalumab 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=5)	1:2	104	82-113
	1:4	101	83-116
	1:8	100	82-113

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)