1. Determination of Serum Infliximab Concentration by Point-of-care Devices in Children with Inflammatory Bowel Disease
- Author
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Gabriele Stocco, Fulvia Vascotto, Alessandro Ventura, Adriana Cifù, Marianna Lucafò, Matteo Bramuzzo, Francesca De Pellegrin, Stefano Martelossi, Debora Curci, Diego Favretto, Martina Fabris, Samuele Naviglio, Giuliana Decorti, Curci, D., Lucafo, M., Cifu, A., Bramuzzo, M., Martelossi, S., Favretto, D., De Pellegrin, F., Fabris, Martino, Vascotto, Fulvia, Naviglio, S., Ventura, A., Stocco, G., and Decorti, G.
- Subjects
Male ,medicine.medical_specialty ,Adolescent ,Point-of-Care Systems ,therapeutic drug monitoring ,Gastroenterology ,Inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Pharmacokinetics ,Gastrointestinal Agents ,030225 pediatrics ,Internal medicine ,antitumor necrosis factor ,enzyme-linked immunosorbent assay ,pharmacokinetics ,Medicine ,Humans ,pharmacokinetic ,Point of care ,medicine.diagnostic_test ,business.industry ,Elisa assay ,medicine.disease ,Serum samples ,Inflammatory Bowel Diseases ,Infliximab ,Therapeutic drug monitoring ,Pediatrics, Perinatology and Child Health ,Trough level ,030211 gastroenterology & hepatology ,Female ,Drug Monitoring ,business ,medicine.drug - Abstract
OBJECTIVES Therapeutic drug monitoring is becoming increasingly important in clinical decision-making in children with inflammatory bowel disease (IBD). However, enzyme-linked immunosorbent assay (ELISA) assays do not allow results to be provided in real-time. We sought to compare 2 point-of-care (POC) devices for quantification of serum infliximab concentration with 2 validated ELISA assays in children with IBD. METHODS We studied 32 serum samples from 19 children with IBD treated with infliximab. Serum samples were collected immediately before drug infusion (trough level). Infliximab was measured using 2 POC infliximab assays, Quantum Blue (POC IFX/QB) and Rida Quick (POC IFX/RQ), and 2 ELISA assays: Lisa-Tracker (used as primary reference), and Promonitor (used as second control). Intraclass correlation coefficient (ICC) was assessed for quantitative comparison. Qualitative analysis was also performed to evaluate whether POC assays would correctly classify infliximab serum according to a target window (between 3 and 7 μg/mL). RESULTS ICC was 0.82 and 0.87 for POC IFX/QB and POC IFX/RQ with the primary reference ELISA assay, respectively; ICC between the 2 ELISA assays was 0.87. Classification of results according to therapeutic intervals showed good agreement between pairs of assays, with kappa of 0.67 and 0.80 for POC IFX/QB and POC IFX/RQ, respectively, with reference ELISA, and 0.81 between the 2 ELISAs. Accuracy of POC assays was better for drug levels
- Published
- 2019