KRIBIOLISA™ Brolucizumab (BEOVU) ELISA

SKU: KBI1206 Category:

58,000.00

Enzyme Immunoassay for the estimation of Brolucizumab (BEOVU) 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:
Brolucizumab is a humanized monoclonal antibody designed for the treatment of neovascular (wet) AMD. In comparision to a full antibody or a Fab fragment, Brolucizumab is a single chain antibody fragment maintaining full binding capacity to VEGF-A, with its better stability and solubility allowing for higher doses in a single injection. Intreavitreal anti-VEGF therapy has revolutionized treatment of wet AMD, and Brolucizumab inhibits all isoforms of VEGF-A. By blocking VEGF-A, brolucizumab reduces the growth of the blood vessels and controls the leakage and swelling.

Intended Use:
For Estimation of Brolucizumab (BEOVU) 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 Brolucizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Brolucizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Brolucizumab 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 Brolucizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Principle:
VEGF-A protein is pre-coated onto microwells. Samples and standards are pipetted into microwells and Brolucizumab present in the sample are bound to the target protein. Then, an Anti-Human IgG conjugated to HRP 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 VEGF-A antibody 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

Species

Human

Biomarker Estimation

measures free drug

Sample Type

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

Calibration Range

0 ng/ml – 2000 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Brolucizumab (BEOVU)

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

Entez Gene ID

ESBA-1008 Human

Alternate Names / Synonyms

Brolucizumab, brolucizumab-dbll

Alternate Drug Brand Names

Beovu

Drug Bank Accession Number

DB14864

ELISA Type

Direct Sandwich Assay

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