i-Tracker Adalimumab
Product Description
i-Tracker Adalimumab is an automated assay intended for the quantitative measurement of Adalimumab (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 Adalimumab 1st International Standard (NIBSC 17/236)
- Validated on Adalimumab drug (Humira®) and biosimilars: ABP 501 (Amgevita®) and SB5 (Imraldi®)
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- Bressler B & al. Clinical Practice Guidelines for the Medical Management of Non-hospitalized Ulcerative Colitis: The Toronto Consensus. Gastroenterology 2015;148:1035 – 1058.
- Diagnostics Guidance [DG22] on Therapeutic monitoring of TNF-alpha Inhibitors in Crohn’s Disease. https://www.nice.org.uk/guidance/dg22/chapter/1-Recommendations
- 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.
- Gomollón F at al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease. J Crohns Colitis. 2016:1-23.
- 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).
- Wadhwa M et al. World Health Organization, WHO Expert Committee on Biological Standardization. (2019). Report on a collaborative study for proposed 1st international standard for Adalimumab. WHO/BS/2019.2365.
- Product Code: CTA 002-100
- Number of Tests: 100
- Sample Type: Serum or plasma
- Sample Volume: 20 µL
- Assay Range: 0.5 - 24 μg/mL
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