KRIBIOLISA™ Omalizumab (XOLAIR) ELISA

SKU: KBI1021 Category:

42,000.00

Enzyme Immunoassay for the estimation of Omalizumab (XOLAIR) 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:
Omalizumab, sold under the trade name Xolair, is a medication originally designed to reduce sensitivity to allergens. It has been used to try to control severe allergic asthma, which does not respond to high doses of corticosteroids and less widely for chronic spontaneous urticaria.Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (Fc& epsilon RI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells.

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

2.5 ng/ml – 160 ng/ml

Sensitivity

2.5 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Omalizumab (XOLAIR)

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

Omalizumab

Alternate Drug Brand Names

Xolair

Drug Bank Accession Number

DB00043

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