Immunodiagnostic Systems Holdings PLC

IDS i-TrackerModel CTI-003-100 - Anti-Infliximab CLIA System

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i-Tracker anti-Infliximab is an automated assay intended for the quantitative measurement of Anti-Infliximab antibodies (anti-drug antibodies: ADAb) in human serum or plasma samples.

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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.

  • Innovative CLIA technology
  • Quantitative measurement of drug and anti-drug antibodies
  • First results in less than 35 minutes; 60 results/hour
  • Validated on Infliximab drug (Remicade®) and biosimilars: SB2 (Flixabi®) and CT-P13 (Remsima® and Inflectra®)
  • Product Code:CTI-003-100
  • 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:100 μL
  • Assay Range:10 ng/mL - 2000 ng/mL