评价afas -10护理点与酶联免疫吸附法在英夫利昔单抗和阿达木单抗治疗药物监测中的准确性和临床应用

IF 2.8 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Therapeutic Drug Monitoring Pub Date : 2025-06-01 Epub Date: 2024-11-15 DOI:10.1097/FTD.0000000000001269
Carles Iniesta-Navalón, Manuel Ríos-Saorín, Rebeca Añez-Castaño, Lorena Rentero-Redondo, Patricia Ortíz-Fernandez, Elena Marín-Armero Martínez, Elena Urbieta-Sanz
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引用次数: 0

摘要

背景:新的护理点(POC)技术提供快速结果,并解决了传统酶联免疫吸附测定(ELISA)方法的一些局限性,例如处理时间长和治疗决策延迟。评估POC检测方法与已有ELISA方法的可比性对于确保治疗药物监测的准确性和可靠性至关重要。本研究旨在评估afas -10 POC法与Promonitor ELISA法在定量英夫利昔单抗(IFX)和阿达木单抗(ADA)血清浓度以及检测抗药抗体(ATIs和ATAs)方面的分析性能和临床应用。方法:于2023年10月至2024年4月进行前瞻性研究,纳入225例免疫介导性疾病患者样本。采用AFIAS-10 POC和Promonitor ELISA法对样品进行分析。为了评估两种方法在量化方面的一致性,采用Bland-Altman分析,检查平均差值并建立一致性限。结果:Pearson相关系数显示IFX (r = 0.932)与ADA (r = 0.967)具有较强的相关性。IFX和ADA的POC与ELISA的平均差异分别为-0.78 mcg/mL和1.54 mcg/mL。与ELISA相比,POC试验倾向于低估IFX浓度和高估ADA浓度。结论:AFIAS-10 POC法与ELISA法定量IFX和ADA、检测抗IFX和抗ADA抗体具有良好的相关性和一致性。然而,在较高的药物浓度下,这种相关性明显较低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluating the Accuracy and Clinical Utility of AFIAS-10 Point of Care Versus Enzyme-Linked Immunosorbent Assay in Therapeutic Drug Monitoring of Infliximab and Adalimumab.

Background: New point-of-care (POC) techniques offer rapid results and address some of the limitations of traditional enzyme-linked immunosorbent assay (ELISA) methods, such as lengthy processing times and delays in therapeutic decision making. It is crucial to evaluate the comparability of POC assays with established ELISA methods to ensure accuracy and reliability in therapeutic drug monitoring. This study aimed to evaluate the analytical performance and clinical utility of the AFIAS-10 POC assay compared with the Promonitor ELISA for quantifying serum concentrations of infliximab (IFX) and adalimumab (ADA) and detecting antidrug antibodies (ATIs and ATAs).

Methods: A prospective study was conducted from October 2023 to April 2024, including 225 samples from patients with immune-mediated diseases. The samples were analyzed using both AFIAS-10 POC and Promonitor ELISA assays. To assess the agreement between the 2 methods in terms of quantification, Bland-Altman analysis was performed by examining the mean difference and establishing limits of agreement.

Results: The Pearson correlation coefficient indicated strong correlations for IFX (r = 0.932) and ADA (r = 0.967) between the 2 assays. The mean difference between POC and ELISA for IFX was -0.78 mcg/mL and for ADA was 1.54 mcg/mL, respectively. The POC assay tended to underestimate IFX concentrations and overestimate ADA concentrations compared with ELISA.

Conclusions: The AFIAS-10 POC assay demonstrated good correlation and concordance with the ELISA method for the quantification of IFX and ADA, as well as for detecting anti-IFX and anti-ADA antibodies. However, this correlation was notably lower at higher drug concentrations.

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来源期刊
Therapeutic Drug Monitoring
Therapeutic Drug Monitoring 医学-毒理学
CiteScore
5.00
自引率
8.00%
发文量
213
审稿时长
4-8 weeks
期刊介绍: Therapeutic Drug Monitoring is a peer-reviewed, multidisciplinary journal directed to an audience of pharmacologists, clinical chemists, laboratorians, pharmacists, drug researchers and toxicologists. It fosters the exchange of knowledge among the various disciplines–clinical pharmacology, pathology, toxicology, analytical chemistry–that share a common interest in Therapeutic Drug Monitoring. The journal presents studies detailing the various factors that affect the rate and extent drugs are absorbed, metabolized, and excreted. Regular features include review articles on specific classes of drugs, original articles, case reports, technical notes, and continuing education articles.
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