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Rapid test detection of anti-infliximab antibodies: performance comparison with three different immunoassays

2020Journal article Open access
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dc.contributor.authorRocha, Cátia
dc.contributor.authorLago, Paula
dc.contributor.authorFernandes, Samuel
dc.contributor.authorCorreia, Luís
dc.contributor.authorPortela, Francisco
dc.contributor.authorVieira, Ana Isabel
dc.contributor.authorPatita, Marta
dc.contributor.authorArroja, Bruno
dc.contributor.authorMinistro, Paula
dc.contributor.authorAlves, Catarina
dc.contributor.authorDias, Cláudia Camila
dc.contributor.authorMagro, Fernando
dc.date.accessioned2022-07-14T14:07:47Z
dc.date.available2022-07-14T14:07:47Z
dc.date.issued2020
dc.description.abstractBackground and aims: Therapeutic drug monitoring (TDM) of infliximab (IFX) and anti-infliximab antibodies (ATIs) is essential for treatment optimisation in inflammatory bowel disease (IBD) patients. The aim of this study was to estimate and compare the agreement and accuracy between a new rapid test and three established enzyme-linked immunosorbent assays (ELISAs) to quantify ATIs levels, and to evaluate the impact of exogenous IFX on the performance of these assays. Methods: We analysed 200 serum samples from 57 IBD outpatients in IFX induction or maintenance therapy at six IBD centres in Portugal. ATI levels were quantified using the rapid test Quantum Blue® (QB) Anti-Infliximab (Bühlmann) and three established ELISAs: In-House, Theradiag (Lisa Tracker Anti-Infliximab), and Immundiagnostik (IDKmonitor Infliximab). ATIs were quantified in patients' serum samples and spiked samples with exogenous IFX, based on analytical and clinical cutoffs. Qualitative agreement and accuracy were estimated by Cohen's kappa (k) with 95% confidence intervals. Results: ATIs quantification with clinical cutoffs showed a slight agreement between QB rapid test and In-House [k = 0.163 (0.051-0.276)] and Immundiagnostik [k = 0.085 (0.000-0.177)]. Regarding IFX/ATIs status, the QB rapid test showed a substantial agreement with Theradiag [k = 0.808 (0.729-0.888)] and a fair agreement with In-House [k = 0.343 (0.254-0.431)] and Immundiagnostik [k = 0.217 (0.138-0.297)]. The QB rapid test could not detect ATI-positive levels in samples with exogenous IFX at 5-300 µg/ml. Interference on ATIs detection was observed at exogenous IFX ⩾30 µg/ml for In-house and Immundiagnostik assays. Conclusion: QB rapid test is only suitable to detect ATI-positive levels in the absence of IFX.pt_PT
dc.description.sponsorshipThe authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded in part by the Portuguese IBD Study Group (GEDII), and in part by PDE/BDE/114583/2016, from Portuguese national funds by Fundação para a Ciência e Tecnologia (FCT).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationRocha C, Lago P, Fernandes S, et al. Rapid test detection of anti-infliximab antibodies: performance comparison with three different immunoassays. Therap Adv Gastroenterol. 2020;13:1756284820965790. doi:10.1177/1756284820965790pt_PT
dc.identifier.doi10.1177/1756284820965790pt_PT
dc.identifier.issn1756-283X
dc.identifier.issn1756-2848
dc.identifier.urihttp://hdl.handle.net/10400.16/2724
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSAGE Publicationspt_PT
dc.relationNovo título: “Anti-drug Antibodies” Anti-TNF pharmacokinetics: In vitro model
dc.relation.publisherversionhttps://journals.sagepub.com/doi/10.1177/1756284820965790?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmedpt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectantibodiespt_PT
dc.subjectdrug monitoringpt_PT
dc.subjectenzyme-linked immunosorbent assaypt_PT
dc.subjectimmunoassaypt_PT
dc.subjectinflammatory bowel diseasespt_PT
dc.subjectinfliximabpt_PT
dc.subjectpoint-of-care systemspt_PT
dc.titleRapid test detection of anti-infliximab antibodies: performance comparison with three different immunoassayspt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.awardTitleNovo título: “Anti-drug Antibodies” Anti-TNF pharmacokinetics: In vitro model
oaire.awardURIinfo:eu-repo/grantAgreement/FCT//PDE%2FBDE%2F114583%2F2016/PT
oaire.citation.conferencePlaceEnglandpt_PT
oaire.citation.startPage175628482096579pt_PT
oaire.citation.titleTherapeutic Advances in Gastroenterologypt_PT
oaire.citation.volume13pt_PT
person.familyNameLAGO VIEIRA DOS SANTOS
person.givenNamePAULA MARIA
person.identifier.ciencia-id5514-3FC4-9C62
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationabe823e2-57bc-45ab-9ab5-a59cfe48dab5
relation.isAuthorOfPublication.latestForDiscoveryabe823e2-57bc-45ab-9ab5-a59cfe48dab5
relation.isProjectOfPublication7e0500b2-f93b-4417-b859-040ade87684e
relation.isProjectOfPublication.latestForDiscovery7e0500b2-f93b-4417-b859-040ade87684e

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