KRIBIOLISA™ Adalimumab ELISA

SKU: KBI1015 Category:

34,000.00

Enzyme Immunoassay for the estimation of Adalimumab (Antigen Capture format) 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:
Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor alpha (TNF alpha). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. Adalimumab binds specifically to (TNF alpha) and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis (Ps) plaques.

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

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

5 ng/ml ? 320 ng/ml

Sensitivity

4.8 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Adalimumab

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-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

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

Citations