- 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®)
i-Tracker Adalimumab is an automated assay intended for the quantitative measurement of Adalimumab (anti-TNFα agent) in human serum or plasma samples.
Anti-TNFα are therapeutic agents widely used to treat patients with various inflammatory diseases. Adalimumab is one of the anti-TNFα agents recommended for the treatment of the rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, etc. This human monoclonal antibody can bind TNFα, blocking the action of the TNFα responsible for the inflammatory state.
However, during the treatment, some patients can develop antibodies against Adalimumab. Consequently, the plasma level of anti-TNFα decreases and simultaneously the disease symptoms reappear or increase.
Studies have shown that the trough level of a TNFα therapy (i.e. the circulating drug level just before the next injection) usually correlates with clinical efficacy. This trough level is influenced by several factors, among them dosage and frequency of the injections, disease phenotype and activity, pharmacogenetic factors, co-medication and the formation of anti-drug antibodies.
Quantitative measurements of anti-TNFα drug level in combination with anti-drug antibodies provides to the treating physician help for therapeutic guidance, allowing maximum treatment efficacy whilst minimising cost impact.
i-Tracker Adalimumab assay is validated to monitor drug levels of any biological drug which contains the active substance Adalimumab, that is the original drug Humira®, and any biosimilar drug like ABP501 (Amgevita®) and SB5 (Imraldi®). It is standardised against the NIBSC/WHO Adalimumab 1st International Standard (code: 17/236).
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