DESCRIPTION

Used for the quantitative determination of Anti-Pertuzumab Neutralizing Antibody concentration in serum and plasma.

PRINCIPLE OF THE ASSAY

This assay employs the quantitative competitive enzyme immunoassay technique. Pertuzumab has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled Human CD340 and then pipetted into the wells. Anti-Pertuzumab Neutralizing Antibody in the sample competitively binds to Pertuzumab with the biotin-labeled Human CD340. 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 inversely proportion to the amount of Anti-Pertuzumab Neutralizing Antibody 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): <20% Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision. Inter-Assay Precision (Precision between assays): <20% 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)		364.3	100.4	46.8	310.0	122.5	69.2
Standard deviation		18.5	6.4	9.1	19.2	14.0	12.9
CV \(%\)		5.1	6.3	19.4	6.2	11.4	18.6

RECOVERY

The recovery of Anti-Pertuzumab Neutralizing Antibody 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	99	86-107
	1:20	102	86-115

LINEARITY

To assess the linearity of the assay, human serum samples were spiked with high concentrations of Anti-Pertuzumab Neutralizing Antibody 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	103	97-116
	1:4	101	91-109
	1:8	105	89-118
	1:16	101	82-116

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)