Comparative evaluation of point of care assay with ELISA techniques for quantifying serum concentrations of ustekinumab in inflammatory bowel disease patients

Gastroenterología y Hepatología (English Edition) Pub Date : 2025-05-29 DOI:10.1016/j.gastre.2025.502277

Carles Iniesta-Navalón , Manuel Ríos-Saorín , Lorena Rentero-Redondo , Rebeca Añez-Castaño , Elena Urbieta-Sanz

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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: <1 μg/mL, 1–4.5 μg/mL, and >4.5 μg/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 5.22 μg/mL (POC-AFIAS), 3.99 μg/mL (ELISA-PRO), and 4.50 μg/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 1.81 μg/mL between POC-AFIAS and ELISA-PRO, and 1.27 μg/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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护理点测定法与ELISA技术定量炎症性肠病患者血清ustekinumab浓度的比较评价

目的评价POC-AFIAS测定法与两种ELISA建立的血清ustekinumab浓度测定法的分析性能和临床应用。方法采用前瞻性研究。收集接受ustekinumab治疗的成年患者的连续血清样本。比较了三种用于ustekinumab血清浓度定量的分析技术：AFIAS-10®POC法（POC- afias）、Promonitor®ELISA法（ELISA- pro）和ELISA Ridascreen®法（ELISA- rdsc）。在三个治疗范围内评估Ustekinumab浓度：<；1 μg/mL, 1 - 4.5 μg/mL和>；4.5 μg/mL。统计分析包括Pearson相关、类内相关系数、Bland-Altman分析。结果共纳入104例患者。中位ustekinumab检测浓度分别为5.22 μg/mL （POC-AFIAS）、3.99 μg/mL （ELISA-PRO）和4.50 μg/mL （ELISA-RDSC）。各技术间存在较强的相关性（POC-AFIAS与ELISA-PRO: r = 0.921， POC-AFIAS与ELISA-RDSC: r = 0.940， ELISA-PRO与ELISA-RDSC: r = 0.976）。Bland-Altman分析显示，POC-AFIAS与ELISA-PRO的偏倚差异为1.81 μg/mL， POC-AFIAS与ELISA-RDSC的偏倚差异为1.27 μg/mL。一致性率因治疗范围而异，治疗范围内一致性最高（97.3%），超治疗浓度一致性较低（74.6%）。结论：本研究表明，POC-AFIAS检测在定量ustekinumab的血清浓度方面提供了与已建立的ELISA技术相当的结果，特别是在治疗范围内。研究结果表明，POC-AFIAS检测为临床实践中管理ustekinumab治疗提供了一种快速有效的工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Gastroenterología y Hepatología (English Edition)

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