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Shikari® (Q-REMS) Infliximab biosimilar ELISA

Enzyme immunoassay for the quantitative determination of free Infliximab-biosimilar (Remsima®) in serum and plasma

This kit has been especially developed for the quantitative determination of infliximab-biosimilar (Remsima®) in serum and plasma samples between the Cmin and Cmax range of concentrations.

 

Infliximab Drug Bank Accession Number is DB00065.

Infliximab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease and ankylosing spondylitis. Infliximab binds with high affinity to soluble and transmembrane forms of TNF-α to disrupt the proinflammatory cascade signaling. Binding of antibodies to TNF-a prevents TNF-a from interacting with its receptors and helps the patient recover. Measurement of biological drug trough levels and antibody to biological drug gained high importance during the course of treatment. These measurements enable dose adjustments and switch to another class of biological drug when necessary.

Remsima®,the world first biosimilar mAb (approved in 2013 by EMA). The Agencys Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Remsima® has been shown to have a comparable quality, safety and efficacy profile to Remicade®. 

All SHIKARI® ELISA kits are suitable for biosimilar work.

All SHIKARI® ELISA kits are produced under ISO 13485 quality system and have CE IVD mark.

For technical inquiry, please contact techsupport@matriksbiotek.com

 

Required Volume (µl) 10
Total Time (min) 70
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 10
Spike Recovery (%) Between 85-115
Shelf Life (year) 1
Assay type Quantitative
Species Reactivity Human
Storage conditions Store at +4°C. Please refer to protocols.
Shipping conditions At room temperature
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Instructions For Use Download
Safety Data Sheet (SDS) Download
Validation Report Download

Publications with this drug

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Pękala, Anna, and Rafał Filip. "Levels of Biosimilar Infliximab during and after Induction Treatment in Crohn’s Disease and Ulcerative Colitis— A Prospective Polish Population Study." Journal of Clinical Medicine 10.22 (2021): 5311. Visit Link
Pękala, Anna, and Rafał Filip. "Anti-Drug Antibodies in Patients with Inflammatory Bowel Diseases Treated with Biosimilar Infliximab: A Prospective Cohort Study" Journal of Clinical Medicine (2021) Visit Link
Saleh, H. H., Khadim , D. J., & Hussein, R. J. (2024). Correlation between Therapeutic Drug Monitoring of Infliximab Serum Trough Levels and other Biomarkers in Iraqi Patients with Crohn’s Disease. Al-Rafidain Journal of Medical Sciences Visit Link