KRIBIOLISA™ Belimumab ELISA

SKU: KBI1181 Category:

58,000.00

Enzyme Immunoassay for the estimation of Belimumab in serum and plasma.

Key features:
1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format
2. Validated as per international bioassay validation guidelines
3. Recovery: 80-120%
4. Precision CV <10%


The below Kit Insert is subject to change with the new lot of kits.

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells



Description

Background:
Belimumab is a fully human recombinant IgG1 monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor. BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE). By binding to BLyS and blocking its interaction with B cell receptors, belimumab inhibits the survival of B cells. It is produced by recombinant DNA technology in a murine cell (NS0) expression system. Belimumab is a B-lymphocyte stimulator (BLyS)-specific inhibitor used to treat systemic lupus erythematosus and active lupus nephritis as an add-on therapy.

Intended Use:
For Estimation of Belimumab in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Belimumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Belimumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Belimumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Belimumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

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Additional information

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

0 – 40 ug/ml

Sensitivity

1 ug/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Belimumab

Cross Reactivity

< 0.5% cross-reactivity observed with related biomarker.

Interference

No significant interference observed with available related molecules.

Regulatory Status

Research Use Only

Research Area

Biosimilars / Therapeutic Drug Monitoring

Alternate Names / Synonyms

Belimumab

Storage Temperature

Store the unopened product at 2-8 Deg C. Opened products to be stored as per temperatures indicated on the datasheet.

Validation

The kit uses a biosimilar research grade standard / calibrator. The standard / calibrator has been validated against WHO/NIBSC standard and/or against commercially sourced innovator drug where available. Please refer to the IFU for more details.

Disclaimer

Trade name indicated is for reference purposes only. It does not reflect any licences or patent usage. The tradename is the registered trademark of the respective owners only.

Long Name

Protein Based Therapies – Monoclonal Antibody