Comparative evaluation of point of care assay with ELISA techniques for quantifying serum concentrations of ustekinumab in inflammatory bowel disease patients.
Carles Iniesta-Navalón, Manuel Ríos-Saorín, Lorena Rentero-Redondo, Rebeca Añez-Castaño, Elena Urbieta-Sanz
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引用次数: 0
Abstract
Objectives: To evaluate the analytical performance and clinical utility of the POC-AFIAS assay in comparison with two ELISA established assays for quantifying serum concentrations of ustekinumab.
Methods: A prospective study was conducted. Consecutive serum samples from adult patients undergoing treatment with ustekinumab were collected. Three analytical techniques were compared for the quantification of ustekinumab serum concentrations: the AFIAS-10® POC assay (POC-AFIAS), the Promonitor® ELISA assay (ELISA-PRO), and the ELISA Ridascreen® assay (ELISA-RDSC). Ustekinumab concentrations were evaluated within three therapeutic ranges: <1μg/mL, 1-4.5μg/mL, and >4.5μg/mL. Statistical analysis included Pearson correlation, intra-class correlation coefficient, and Bland-Altman analysis.
Results: A total of 104 patients were included in the study. The median ustekinumab concentrations measured were 5.22μg/mL (POC-AFIAS), 3.99μg/mL (ELISA-PRO), and 4.50μg/mL (ELISA-RDSC). Strong correlations were observed between techniques (POC-AFIAS and ELISA-PRO: r=0.921, POC-AFIAS and ELISA-RDSC: r=0.940, ELISA-PRO and ELISA-RDSC: r=0.976). The Bland-Altman analysis revealed a bias difference of 1.81μg/mL between POC-AFIAS and ELISA-PRO, and 1.27μg/mL between POC-AFIAS and ELISA-RDSC. Agreement rates varied by therapeutic range, with the highest agreement observed within the therapeutic range (97.3%) and lower agreement for supra-therapeutic concentrations (74.6%).
Conclusion: This study demonstrated that the POC-AFIAS assay provides comparable results to established ELISA techniques for quantifying serum concentrations of ustekinumab, particularly within the therapeutic range. The findings suggest that the POC-AFIAS assay offers a rapid and effective tool for managing ustekinumab therapy in clinical practice.
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Gastroenterology and Hepatology is the first journal to cover the latest advances in pathology of the gastrointestinal tract, liver, pancreas, and bile ducts, making it an indispensable tool for gastroenterologists, hepatologists, internists and general practitioners.
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