DESCRIPTION

Used for the quantitative determination of Romiplostim concentration in serum and plasma.

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. An antibody specific for Romiplostim has been pre-coated onto a microplate. Standards or samples are pipetted into the wells and any Romiplostim present is bound by the immobilized antibody. After washing away any unbound substances, a biotin-labeled antibody specific for Romiplostim 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 Romiplostim 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
Standard deviation		13.4	5.8	1.4	11.8	4.1	3.2
CV \(%\)		3.8	7.8	8.2	3.4	5.1	13.9

RECOVERY

The recovery of Romiplostim 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)	1:1	98	87-115
	1:2	99	86-112

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Romiplostim 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	104	95-110
	1:4	105	93-112
	1:8	101	99-102
	1:16	90	82-97

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)