title: Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays.
abstract: Therapeutic drug monitoring is a powerful strategy known to improve the clinical outcomes and to optimise the healthcare resources in the treatment of autoimmune diseases. Currently, most of the methods commercially available for the quantification of infliximab (IFX) are ELISA-based, with a turnaround time of approximately 8 h, and delaying the target dosage adjustment to the following infusion.
  
  
  
  To validate the first point-of-care IFX quantification device available in the market - the Quantum Blue Infliximab assay (Buhlmann, Schonenbuch, Switzerland) - by comparing it with two well-established methods.
  
  
  
  The three methods were used to assay the IFX concentration of spiked samples and of the serum of 299 inflammatory bowel diseases (IBD) patients undergoing IFX therapy.
  
  
  
  The point-of-care assay had an average IFX recovery of 92%, being the most precise among the tested methods. The Intraclass Correlation Coefficients of the point-of-care IFX assay vs. the two ELISA-based established methods were 0.889 and 0.939. Moreover, the accuracy of the point-of-care IFX compared with each of the two reference methods was 77% and 83%, and the kappa statistics revealed a substantial agreement (0.648 and 0.738).
  
  
  
  The Quantum Blue IFX assay can successfully replace the commonly used ELISA-based IFX quantification kits. This point-of-care IFX assay is able to deliver the results within 15 min makes it ideal for an immediate target concentration adjusted dosing. Moreover, it is a user-friendly desktop device that does not require specific laboratory facilities or highly specialised personnel.
authors: Department of Pharmacology and Therapeutics, University of Porto, Porto, Portugal.|MedInUP, Centre for Drug Discovery and Innovative Medicines, Porto, Portugal.
authors: J
authors: J
authors: Afonso
authors: Centro Hospitalar São João, Porto, Portugal.
authors: S
authors: S
authors: Lopes
authors: Hospital de Braga, Braga, Portugal.
authors: R
authors: R
authors: Gonçalves
authors: Centro Hospitalar do Algarve, Faro, Portugal.
authors: P
authors: P
authors: Caldeira
authors: Centro Hospitalar do Porto, Porto, Portugal.
authors: P
authors: P
authors: Lago
authors: Centro Hospitalar do Algarve, Portimão, Portugal.|University of Algarve, Faro, Portugal.
authors: H
authors: H
authors: Tavares de Sousa
authors: Centro Hospitalar de Lisboa, Lisboa, Portugal.
authors: J
authors: J
authors: Ramos
authors: Centro Hospitalar Lisboa Norte, Lisboa, Portugal.
authors: A R
authors: AR
authors: Gonçalves
authors: Hospital de S. Teotónio, Viseu, Portugal.
authors: P
authors: P
authors: Ministro
authors: Instituto Português de Oncologia de Lisboa, Lisboa, Portugal.
authors: I
authors: I
authors: Rosa
authors: Hospital Garcia de Orta, Almada, Portugal.
authors: A I
authors: AI
authors: Vieira
authors: Health Information and Decision Sciences Department, Faculty of Medicine, University of Porto, Porto, Portugal.|Center for Health Technology and Services Research, Porto, Portugal.
authors: C C
authors: CC
authors: Dias
authors: Department of Pharmacology and Therapeutics, University of Porto, Porto, Portugal.|MedInUP, Centre for Drug Discovery and Innovative Medicines, Porto, Portugal.|Centro Hospitalar São João, Porto, Portugal.
authors: F
authors: F
authors: Magro
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001681:Biological Assay / Q000379:methods; D016903:Drug Monitoring / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000097:blood*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000069285:Infliximab