KRIBIOLISA™ Anti-Adalimumab ELISA

SKU: KBI2015 Category:

35,000.00

Enzyme Immunoassay for the quantitative determination of Anti-Adalimumab antibodies in human serum and plasma.

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:
Adalimumab, sold under the trade name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination, it nearly doubles the response rate of methotrexate alone. Adalimumab is a TNF-inhibiting, anti-inflammatory, biologic medication. It binds to tumor necrosis factor-alpha (TNF alpha), which normally binds to TNF alpha receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNF alpha adalimumab reduces this inflammatory response, as it is also part of the immune system, which protects the body from infection, treatment with adalimumab may increase the risk of infections. 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 Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Adalimumab antibodies and may be used for monitoring immunogenicity.

Intended Use:
The KRIBIOLISA Anti-Adalimumab ELISA is used as an analytical tool for quantitative determination of Anti-Adalimumab antibodies in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. A commercially available Adalimumab is pre-coated onto microwells. Samples and Standards are pipetted into microwells and antibodies to Adalimumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Adalimumab is pipette and incubated simultaneously with samples. 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-Adalimumab 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

10 ng/ml ? 640 ng/ml

Detection Method

Colorimetric

Regulatory Status

Research Use Only

Research Area

Cancer

Entez Gene ID

ABP-501 Human

Alternate Names / Synonyms

Adalimumab, Adalimumab (genetical recombination), adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp

Alternate Drug Brand Names

Amjevita, Humira

Drug Bank Accession Number

DB00051

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.