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i-Tracker Certolizumab

Product Description

i-Tracker Certolizumab is an automated assay intended for the quantitative measurement of Certolizumab (anti-TNFα agent) in human serum or plasma samples.

  • Innovative CLIA technology
  • Quantitative measurement of drug and anti-drug antibodies
  • First results in less than 35 minutes; 60 results/hour
  • Validated on princeps and biosimilars
  • Controls and calibrators included
    1. Vande Casteele N, Feagan B, Vermeire S, et al. Covariates influencing the exposure-response relationship for certolizumab pegol during the induction and maintenances phases in patients with Crohn’s disease. Am J Gastroenterol 2016;111:S262–S263.
    2. Vande Casteele, N., Feagan, B.G., Vermeire, S. et al. Exposure–response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn’s disease. Aliment Pharmacol Ther. 2018; 47: 229–237
    3. Colombel JF, Sandborn WJ, Allez M, et al. Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn’s Disease. Clinical Gastroenterology and Hepatology 2014;12:423–431
    4. Paul S, et al.. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751.
    5. S. Paul, et al. Exposure-Response Relationship Of Certolizumab Pegol And Achievement of Low Disease Activity and Remission In Patients with rheumatoid arthritis. Clin Transl Sci 2020 Feb 26
    6. Gehin JE, Goll GL, Warren DJ, et al. Anti-drug antibodies to certolizumab pegol are associated with low drug levels and reduced clinical response at 3 months in patients with inflammatory joint diseases. data from the nor-dmard study. Annals of the Rheumatic Diseases 2018;77:844

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i-Tracker Certolizumab

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