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

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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引用次数: 0

摘要

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。

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

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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Gastroenterología y Hepatología (English Edition)

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