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Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays

dc.contributor.authorAfonso, J.
dc.contributor.authorLopes, S.
dc.contributor.authorGonçalves, R.
dc.contributor.authorCaldeira, Paulo
dc.contributor.authorLago, P.
dc.contributor.authorSousa, Helena Tavares
dc.contributor.authorRamos, J.
dc.contributor.authorGonçalves, A. R.
dc.contributor.authorMinistro, P.
dc.contributor.authorRosa, I.
dc.contributor.authorVieira, A. I.
dc.contributor.authorDias, C. C.
dc.contributor.authorMagro, F.
dc.date.accessioned2017-04-07T15:55:56Z
dc.date.available2017-04-07T15:55:56Z
dc.date.issued2016-10
dc.description.abstractBackgroundTherapeutic 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 8h, and delaying the target dosage adjustment to the following infusion.AimTo 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.MethodsThe 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.ResultsThe 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).ConclusionsThe 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 15min 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.
dc.identifier.doi10.1111/apt.13757
dc.identifier.issn0269-2813
dc.identifier.otherAUT: PMC02530;
dc.identifier.urihttp://hdl.handle.net/10400.1/9267
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.isbasedonWOS:000383628600004
dc.titleProactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage692
oaire.citation.issue7
oaire.citation.startPage684
oaire.citation.titleAlimentary Pharmacology and Therapeutics
oaire.citation.volume44
person.familyNameCaldeira
person.familyNameSousa
person.givenNamePaulo
person.givenNameHelena Tavares
person.identifier.ciencia-id1112-F0B2-19A3
person.identifier.ciencia-idCF1F-1163-1C4A
person.identifier.orcid0000-0002-2404-6295
person.identifier.orcid0000-0002-6626-205X
rcaap.rightsrestrictedAccess
rcaap.typearticle
relation.isAuthorOfPublication3def3720-8982-4c46-801d-af640d508b59
relation.isAuthorOfPublication6b1d11dd-486f-4fb3-b41f-02e1cf6a5c2e
relation.isAuthorOfPublication.latestForDiscovery6b1d11dd-486f-4fb3-b41f-02e1cf6a5c2e

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