Performance of a New Rapid Point-of-Care Test for Infliximab Levels in Patients with Inflammatory Bowel Disease: A Comparison to ELISA

Background Therapeutic drug monitoring of infliximab levels in patients with inflammatory bowel disease (IBD) optimizes patients’ treatment. The reference technique is based on enzyme-linked immunosorbent assay (ELISA) although point of care (POC) assays are being developed. Aims To assess the perfo...

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Published in:Digestive diseases and sciences 2024-01, Vol.69 (1), p.228-234
Main Authors: Valdés-Delgado, Teresa, Aguado-Paredes, Alicia, Merino-Bohórquez, Vicente, Martín-Manzanares, Jesús, Alonso, María Mercedes, Maldonado, Belén, Castro, Luisa, Belvis, María, Benítez, Beatriz, Caunedo, Ángel, Calleja, Miguel Ángel, Argüelles-Arias, Federico
Format: Article
Language:English
Subjects:
Biochemistry
Drug Monitoring - methods
Enzyme-Linked Immunosorbent Assay - methods
Gastroenterology
Gastrointestinal Agents
Hepatology
Humans
Inflammatory bowel disease
Inflammatory Bowel Diseases - diagnosis
Inflammatory Bowel Diseases - drug therapy
Infliximab
Medicine
Medicine & Public Health
Oncology
Original
Original Article
Point-of-Care Testing
Prospective Studies
Transplant Surgery
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Summary:Background Therapeutic drug monitoring of infliximab levels in patients with inflammatory bowel disease (IBD) optimizes patients’ treatment. The reference technique is based on enzyme-linked immunosorbent assay (ELISA) although point of care (POC) assays are being developed. Aims To assess the performance of a new rapid immunochromatographic POC assay (Promonitor Quick IFX) compared with ELISA technique to measure infliximab levels in patients with IBD. Methods A prospective, observational, unicentric study was performed on capillary blood samples from patients with IBD before infliximab infusion (trough levels). Infliximab levels and anti-infliximab antibodies were measured using the ELISA technique (Promonitor IFX) and the POC assay. Correlation between both techniques was assessed by Pearson’s coefficient. Quantitative differences were evaluated by Bland–Altman analysis. Samples were stratified according to infliximab therapeutic ranges ( 8 μg/mL). Results A total of 135 experimental samples were assessed. Infliximab levels showed a high correlation between POC and ELISA tests ( r  = 0.84, P  
ISSN:0163-2116
1573-2568
DOI:10.1007/s10620-023-08139-1