Carles Iniesta-Navalón, Manuel Ríos-Saorín, Rebeca Añez-Castaño, Lorena Rentero-Redondo, Patricia Ortíz-Fernandez, Elena Marín-Armero Martínez, Elena Urbieta-Sanz
{"title":"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","authors":"Carles Iniesta-Navalón, Manuel Ríos-Saorín, Rebeca Añez-Castaño, Lorena Rentero-Redondo, Patricia Ortíz-Fernandez, Elena Marín-Armero Martínez, Elena Urbieta-Sanz","doi":"10.1097/FTD.0000000000001269","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 3","pages":"346-352"},"PeriodicalIF":2.8000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Carles Iniesta-Navalón, Manuel Ríos-Saorín, Rebeca Añez-Castaño, Lorena Rentero-Redondo, Patricia Ortíz-Fernandez, Elena Marín-Armero Martínez, Elena Urbieta-Sanz\",\"doi\":\"10.1097/FTD.0000000000001269\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":23052,\"journal\":{\"name\":\"Therapeutic Drug Monitoring\",\"volume\":\"47 3\",\"pages\":\"346-352\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Drug Monitoring\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/FTD.0000000000001269\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/11/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Drug Monitoring","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/FTD.0000000000001269","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/15 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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.
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.