IDS i-Tracker - Model CTI-002-100 -Automated Chemiluminescence Immunoassay (CLIA) System

• 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®)

• Product Code:CTI-002-100
• Certification: CE Marked
• Clinical Area:Therapeutic Drug Monitoring Solutions
• Type:Automated
• Format:Automated Chemiluminescence Immunoassay (CLIA)
• RUO/IVD:IVD
• Number of Tests:100
• Sample Type:Serum or plasma
• Sample Volume:20 μL
• Assay Range:0.3 μg/mL - 24 μg/mL

Anti-TNFα are therapeutic agents widely used to treat patients with various inflammatory diseases. Infliximab is one of the anti-TNFα agents recommended for the treatment of the rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, etc.  This chimeric 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 Infliximab.  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 Infliximab assay is validated to monitor drug levels of any biological drug which contains the active substance Infliximab, that is the original drug Remicade®, and any biosimilar drug like CT-P13 (Remsima® or Inflectra®) and SB2 (Flixabi® or Renflexis®).  It is standardised against the NIBSC/WHO Infliximab 1st International Standard (code: 16/170).