KRIBIOLISA™ Burosumab (CRYSVITA) ELISA

SKU: KBI1209 Category:

58,000.00

Enzyme Immunoassay for the estimation of Burosumab (CRYSVITA) 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:
Burosumab (KRN23) is an entirely human monoclonal IgG1 antibody that binds excess fibroblast growth factor 23 (FGF23) and has been successfully tested in clinical trials in children with X-linked hypophosphatemic rickets. The U.S. Food and Drug Administration approved Crysvita (burosumab) in April 2018. This is the first drug approved to treat adults and children ages 1 year and older with X-linked hypophosphatemia (XLH), which is a rare, inherited form of rickets. X-linked hypophosphatemia causes low circulating levels of phosphorus in the blood. It causes impaired bone growth and development in children and adolescents and issues with bone mineralization throughout a patients life. XLH is a serious disease which affects about 3,000 children and 12,000 adults in the United States. Most children with XLH suffer from bowed or bent legs, short stature, bone pain and severe dental pain. Some adults with this condition suffer from persistent, unrelenting discomfort and complications, such as joint pain, impaired mobility, tooth abscesses and hearing loss.

Intended Use:
For Estimation of Burosumab (CRYSVITA) 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 Burosumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Burosumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Burosumab 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 Burosumab 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 ng/ml – 32000 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Burosumab (CRYSVITA)

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

KRN-23 Human

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