AI Article Synopsis
- The study evaluated the effectiveness of Theradiag's chemiluminescent immunoassays in measuring serum levels of TNF-alpha inhibitors (Infliximab and Adalimumab) compared to Sanquin Diagnostics' ELISAs.
- Results showed strong positive correlations in serum concentration assessments, but notable bias was present in Theradiag's measurements compared to Sanquin.
- While the Theradiag ADA assays demonstrated moderate to good agreement for detecting both free and bound anti-drug antibodies, the assay focused solely on free antibodies showed poor agreement for both biologics.
Article Abstract
Background: Therapeutic drug monitoring of biological Tumor Necrosis Factor (TNF)-alpha inhibitors is of critical importance. In this study, the performance of practically advantageous chemiluminescent immunoassays of Theradiag, assessing Infliximab and Adalimumab serum concentrations and anti-drug antibodies (ADA) against these biologics, were compared to the Enzyme-Linked Immuno-Sorbent Assays (ELISAs) from Sanquin Diagnostics.
Methods: Leftover serum samples ( = 80 for each parameter) from patients treated with Infliximab or Adalimumab were collected. Correlation and agreement analyses for serum concentration and ADAs, respectively, were performed. Both Theradiag ADA assays, an assay targeting both free and bound ADAs and an assay targeting solely free ADAs, were investigated and compared to the Sanquin Diagnostics ADA assay, targeting both free and bound ADAs.
Results: Strong positive correlations were observed between the biologic concentration assessment of Infliximab (Spearman's Rho = 0.91) and Adalimumab (Spearman's Rho = 0.94). However, there appeared to be significant bias in the Theradiag assay when compared to Sanquin (Infliximab median (Confidence Interval (CI)) = 2.1 (1.7-2.6) µg/mL; Adalimumab median (CI) = 0.8 (0.5-0.9) µg/mL). Agreement analyses showed moderate to good agreement for the Theradiag and Sanquin Diagnostics ADA assays, when detecting both free and bound ADAs, for Infliximab (Cohen's = 0.717) and Adalimumab (Cohen's = 0.802). In contrast, the Theradiag ADA assay detecting solely free ADAs had zero to poor agreement for Infliximab (Cohen's = 0.458) and Adalimumab (Cohen's = 0.119), respectively.
Conclusions: This study demonstrated strong correlations and good agreement between the Theradiag and Sanquin Diagnostics assays measuring Infliximab and Adalimumab serum concentrations and ADAs, both free and bound, against these biologics. Discordance analyses showed significantly decreased drug concentrations in the solely free assays, indicating that the combined detection of free and bound ADAs better aligns with drug levels.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417797 | PMC |
| http://dx.doi.org/10.3390/antib13030073 | DOI Listing |
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