KRIBIOLISA™ Anti-Infliximab (REMICADE) ELISA

SKU: KBI2011 Category:

35,000.00

Enzyme Immunoassay for the quantitative Determination of Anti-Infliximab antibodies in serum, plasma and cell culture supernatant.

Key features:
1. Quantitative estimation of anti-drug antibodies
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

Introduction:
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 Crohn disease. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against infliximab and can be responsible for allergic reaction, or even anaphylactic shock.

Intended Use:
The KRIBIOLISA Anti-Infliximab (Remicade) ELISA is used as an analytical tool for quantitative determination of Anti-Infliximab antibodies in serum, plasma and cell culture supernatant. It may be used for monitoring immunogenicity.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Infliximab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Infliximab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Infliximab 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 Anti-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 antibodies to the drug

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

10 ng/ml – 640 ng/ml

Sensitivity

50 ng/ml

Detection Method

Colorimetric

Regulatory Status

Research Use Only

Research Area

Inflammation

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 has been validated against international bioassay validation guidelines. 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.