i-Tracker Infliximab
Product Description
i-Tracker Infliximab is an automated assay intended for the quantitative measurement of Infliximab (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
- Standardised to the Infliximab 1st International Standard (NIBSC 16/170)
- Validated on Infliximab drug (Remicade®) and biosimilars: SB2 (Flixabi®) and CT-P13 (Remsima® and Inflectra®)
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- Bressler B et al. Clinical Practice Guidelines for the Medical Management of Non-hospitalized Ulcerative Colitis: The Toronto Consensus. Gastroenterology 2015;148:1035 – 1058.
- Lichtenstein, G et al. Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517.
- Maaser C et al. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 1: Initial diagnosis, monitoring of known IBD, detection of complications. J Crohns Colitis. 2019 Feb 1;13(2):144-164.
- Jentzer A et al. Short Communication: Evaluation of infliximab and anti-infliximab LISA-TRACKER immunoassays for the therapeutic drug monitoring of SB2 infliximab biosimilar. Ther Drug Monit. 2018 Sep 21.
- Ruemmele F.M. et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn’s disease. Journal of Crohn’s and Colitis (2014).
- Metcalfe C et al. World Health Organization, WHO Expert Committee on Biological Standardization. (2017). Report on a collaborative study for proposed 1st international standard for Infliximab. WHO/BS/2017.2323.
- Product Code: CTI 002-100
- Number of Tests: 100
- Sample Type: Serum or plasma
- Sample Volume: 20 μL
- Assay Range: 0.3 - 24 μg/mL
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