Infliximab trough levels: A comparison between the Quantum Blue Infliximab assay and the established ELISA.
inflammatory bowel disease
infliximab trough level
therapeutic drug monitoring
Journal
Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
14
05
2019
revised:
30
11
2019
accepted:
22
12
2019
pubmed:
28
12
2019
medline:
4
11
2020
entrez:
28
12
2019
Statut:
ppublish
Résumé
Therapeutic drug monitoring of infliximab (IFX) using the established laboratory-based enzyme-linked immunosorbent assay (ELISA) cannot produce results fast enough to allow IFX dose adjustments prior to each IFX infusion. We investigate the validity of IFX trough levels obtained through the Quantum Blue IFX (QB-IFX) rapid assay compared with the established ELISA. Adult inflammatory bowel disease patients receiving maintenance IFX infusions at Middlemore Hospital and Dunedin Public Hospital were prospectively recruited from July to October 2016. Serum samples were stored at -40 °C until processed using QB-IFX by a clinician at Middlemore Hospital and a research staff at Dunedin Public Hospital strictly following the manufacturers' instructions in an open label fashion. Forty four inflammatory bowel disease patients were recruited. Median duration of IFX therapy was 21 months (interquartile range: 12-44). Overall, the correlation between ELISA and QB-IFX trough levels was 0.73 (95% confidence interval [CI]: 0.53-0.85). The sensitivity and specificity of a QB-IFX level < 7 in detecting an ELISA level < 7 were 0.79 (95% CI: 0.59-0.92) and 0.75 (95% CI: 0.48-0.93), respectively. Conversely, the sensitivity and specificity of a QB-IFX level < 2 detecting an ELISA level < 2 were 1.00 (95% CI: 0.52, 1.00) and 0.97 (95% CI: 0.85, 1.00), respectively. The QB-IFX had excellent sensitivity and specificity for IFX levels < 2 obtained with the established ELISA. Therefore, QB-IFX could be used for real time dosing decisions when the IFX level is low and dose escalation is required.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
Therapeutic drug monitoring of infliximab (IFX) using the established laboratory-based enzyme-linked immunosorbent assay (ELISA) cannot produce results fast enough to allow IFX dose adjustments prior to each IFX infusion. We investigate the validity of IFX trough levels obtained through the Quantum Blue IFX (QB-IFX) rapid assay compared with the established ELISA.
METHODS
METHODS
Adult inflammatory bowel disease patients receiving maintenance IFX infusions at Middlemore Hospital and Dunedin Public Hospital were prospectively recruited from July to October 2016. Serum samples were stored at -40 °C until processed using QB-IFX by a clinician at Middlemore Hospital and a research staff at Dunedin Public Hospital strictly following the manufacturers' instructions in an open label fashion.
RESULTS
RESULTS
Forty four inflammatory bowel disease patients were recruited. Median duration of IFX therapy was 21 months (interquartile range: 12-44). Overall, the correlation between ELISA and QB-IFX trough levels was 0.73 (95% confidence interval [CI]: 0.53-0.85). The sensitivity and specificity of a QB-IFX level < 7 in detecting an ELISA level < 7 were 0.79 (95% CI: 0.59-0.92) and 0.75 (95% CI: 0.48-0.93), respectively. Conversely, the sensitivity and specificity of a QB-IFX level < 2 detecting an ELISA level < 2 were 1.00 (95% CI: 0.52, 1.00) and 0.97 (95% CI: 0.85, 1.00), respectively.
CONCLUSION
CONCLUSIONS
The QB-IFX had excellent sensitivity and specificity for IFX levels < 2 obtained with the established ELISA. Therefore, QB-IFX could be used for real time dosing decisions when the IFX level is low and dose escalation is required.
Substances chimiques
Infliximab
B72HH48FLU
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1302-1306Subventions
Organisme : Gut Health Network, University of Otago, New Zealand
Organisme : Middlemore Clinical Trials, Middlemore Hospital, New Zealand
Informations de copyright
© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
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