KRIBIOLISA™ Ranibizumab (LUCENTIS) ELISA

SKU: KBI1029 Category:

42,000.00

Enzyme Immunoassay for the estimation of Ranibizumab (LUCENTIS) 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%

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



Description

Background:
Ranibizumab (Lucentis) is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes angiogenesis throughout the body and in the eye. Through binding to VEGF-A, ranibizumab interrupts the interaction of VEGF with its receptors, and thus prevents the subsequent growth of new blood vessels.

Intended Use:
For Estimation of Ranibizumab (LUCENTIS) 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 Ranibizumab are pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human Ranibizumab present in the sample are bound by the capture antibody. 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 Ranibizumab 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

0.125 ng/ml – 10 ng/ml

Sensitivity

18.5 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Ranibizumab (LUCENTIS)

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

RG-3645 Human

Alternate Names / Synonyms

Ranibizumab, rhuFab V2

Alternate Drug Brand Names

Byooviz, Cimerli, Lucentis, Susvimo

Drug Bank Accession Number

DB01270

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