AI Article Synopsis
- This study evaluates the reliability of three different ELISA assays for measuring infliximab trough levels (IFX-TL) and antibodies against infliximab (ATI) in children with inflammatory bowel diseases (IBD).
- The findings show that the three assays provide comparable IFX-TL results with a strong statistical correlation, though there are some discrepancies in therapeutic interval classifications, especially with one specific assay.
- Overall, while the assays agree well, caution is advised in interpreting results that are close to therapeutic thresholds due to potential variations in classifications.
Article Abstract
Many clinical studies in paediatric inflammatory bowel diseases (IBD) use infliximab trough level (IFX-TL) and detection of antibody against infliximab (ATI). Hence, comparison of commercially available assays is needed in paediatric samples to assess their reliability and their comparability. We measured IFX-TL and ATI-TL in sera samples of 53 IBD children using three ELISA kits: Lisa-Tracker® Duo Infliximab (Theradiag®), Ridascreen® IFX monitoring (R-Biopharm®) and Promonitor® IFX (Grifols®). Regarding IFX-TL, median values were comparable (p > 0.05), a good statistical correlation has been observed (0.73 ≤ R ≤ 0.85) between tested assays and the Bland-Altman analysis found an excellent agreement with a bias estimated between -0.56 and 0.12 and few values outside the 95% limits of agreement. However, qualitative comparison with therapeutic interval classifications showed some discrepancies (30.2%), mainly due to values near thresholds and more often than not with Theradiag® (22.6%). For ATI, because of non-standardized units, the qualitative comparison found a sensibly good agreement (98.1%). These data show a good agreement of IFX-TL and ATI measurement between three marketed ELISA assays with a small bias obtained. Variations in some results can lead to divergent therapeutic interval classifications and prompt us to be cautious in the interpretation of values near therapeutic thresholds.
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| http://dx.doi.org/10.1016/j.biologicals.2021.02.002 | DOI Listing |
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