Ianalumab ELISA Kit

Catalog No.

KDJ42201

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD268 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Ianalumab in the sample competitively binds to the pre-coated protein with biotin-labeled Ianalumab. 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 Ianalumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

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

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

15.63 - 1,000 ng/mL

Sensitivity

8.91 ng/mL

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.

	Intra-Assay Precision			Inter-Assay Precision
Sample	1	2	3	1	2	3
n	16	16	16	24	24	24
Mean (ng/mL)	590.2	150.5	35.5	723.1	160.5	37.6
Standard deviation	44.6	6.0	2.0	97.2	11.8	4.7
CV (%)	7.6	4.0	5.7	13.4	7.4	12.4

 

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.

Alternative Names

VAY-736, CAS: 1929549-92-7

Background

Ianalumab (VAY736) is an anti-B-cell activating factor (BAFF) receptor fully human IgG1 monoclonal antibody, engineered for direct ADCC-mediated B-cell depletion, thus providing a dual mode of action and targeted approach to treat pSS. The current phase 2b study aimed at establishing a dose-response relationship over a wide range of VAY736 doses, using change from baseline (BL) in the EULAR Sjogren’s Syndrome Disease Activity index (ESSDAI) over 24 Weeks (Wks) as the primary endpoint. Here we report Wk24 efficacy and safety. The study is ongoing with a second blinded treatment period up to Wk52.

Document Download

Ianalumab ELISA Kit.pdf