KRIBIOLISA™ Palivizumab (SYNAGIS) ELISA

SKU: KBI1080 Category:

65,800.00

Enzyme Immunoassay for the estimation of Palivizumab (SYNAGIS) 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:
Palivizumab is a humanized monoclonal antibody (IgG1k) that binding the (respiratory syncytial virus) RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab targets the fusion protein of RSV,[8] inhibiting its entry into the cell and thereby preventing infection. Palivizumab was approved for medical use in 1998.

Intended Use:
For Estimation of Palivizumab (SYNAGIS) 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 enzyme immunoassay technique. Standards or samples are pipetted into microwells pre-coated with Anti- Palivizumab antibody and Palivizumab present in the sample and standards are bound by Anti- Palivizumab antibody. In the second step, Detection antidody is added and incubated. In the third step, a HRP conjugate is pipetted and incubated. Free HRP conjugate will be removed by washing. Addition of TMB substrate will develop blue color and intensity of blue colour in wells is proportional to the concentration of Palivizumab present in standard or 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

200 ng/ml – 1000 ng/ml

Sensitivity

80 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Palivizumab (SYNAGIS)

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

MEDI 493 Human

Alternate Names / Synonyms

Palivizumab

Alternate Drug Brand Names

Synagis

Drug Bank Accession Number

DB00110

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