P202 Quantum blue anti-infliximab: development and evaluation of a point of care rapid test for measuring anti-infliximab antibodies in human serum

Bantleon, F; Schneider, M; Ricken, B; Velayutham, S; Trapani, Davide; Afonso, Joana; Magro, Fernando; Abel, A. Lawrence

doi:10.1093/ecco-jcc/jjy222.326

Cited by 1 publication

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“…Therefore, the development of a rapid anti-IFX test allows a rapid quantification of ATIs, increasing the effectiveness of TDM and the immediate adjustment of the drug. 20 , 21 In these present study, we evaluated and compared the qualitative agreement and accuracy of one rapid point-of-care test and three established ELISAs. Moreover, the impact of IFX on the quantification of ATI levels by the four assays was evaluated.…”

Section: Discussionmentioning

confidence: 99%

“…Table 1 shows the baseline demographic and clinical characteristics of the patients. Briefly, patients had a median age at diagnosis of 29 (19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36) Table 2, a moderate agreement was found between the QB rapid test and Theradiag (k = 0.489), while a slight agreement was observed between the QB rapid test and In-House (k = 0.160) and QB rapid test and Immundiagnostik (k = 0.139). Comparisons between the remaining assay pairs revealed fair agreements (Table 2).…”

Section: Study Populationmentioning

confidence: 99%

“…In contrast, recent developments in rapid point-of-care tests allow the semi-quantitative assessment of ATI levels from the patient’s serum within minutes. 20 , 21 In fact, the recent development of a rapid test to ATIs quantification (Quantum Blue® Anti-Infliximab, Bühlmann) promise a fast detection of ATIs (15–20 min turnaround time) on a single sample. 20 These assays facilitate TDM and immediate adjustment of the IFX dosage.…”

Section: Introductionmentioning

confidence: 99%

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

Rocha

Lago

Correia

et al. 2020

Therap Adv Gastroenterol

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Background 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.

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Section: Discussionmentioning

confidence: 99%