KRIBIOLISA™ Infliximab (REMICADE) ELISA

SKU: KBI1011 Category:

34,000.00

Enzyme Immunoassay for the estimation of Infliximab (REMICADE) in serum and plasma. Calibrated against international WHO standard 16/170 from NIBSC.

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:
Infliximab is a monoclonal antibody which has high specificity for TNF alpha, and does not neutralize TNF beta. Infliximab causes programmed cell death of TNF alpha expressing activated T lymphocytes, an important cell type mediating inflammation; hence it is generally assumed that resolution of activated T cells by Infliximab explains its efficacy in Crohns disease.

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

10 ng/ml ? 160 ng/ml

Sensitivity

8 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Infliximab (REMICADE)

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

ABP 710 Human

Alternate Names / Synonyms

Infliximab, Infliximab (genetical recombination), Infliximab-abda, Infliximab-axxq, Infliximab-dyyb, Infliximab-qbtx

Alternate Drug Brand Names

Avsola, Flixabi, Inflectra, Remicade, Renflexis

Drug Bank Accession Number

DB00065

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