{"title":"Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats.","authors":"Zhihua Jiang","doi":"10.1080/17576180.2025.2464421","DOIUrl":null,"url":null,"abstract":"<p><p>Singlicate anti-drug antibody (ADA) analysis is gaining recognition as a promising approach to optimize immunogenicity assessment. It offers significant benefits in terms of cost-effectiveness and aligns with patient-centric principles. However, its successful implementation requires a thorough understanding of its impacts on assay performance. In this perspective, we review recent case studies comparing singlicate and duplicate formats, focusing on cut point factors and sample result agreement, and seek to discuss how singlicate influences assay cut points and explore considerations for low positive control criteria under singlicate conditions. Furthermore, we propose a strategy for implementing singlicate analysis in both new and existing ADA assays, hoping to contribute to ongoing discussions in this area.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-7"},"PeriodicalIF":1.9000,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bioanalysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17576180.2025.2464421","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
Singlicate anti-drug antibody (ADA) analysis is gaining recognition as a promising approach to optimize immunogenicity assessment. It offers significant benefits in terms of cost-effectiveness and aligns with patient-centric principles. However, its successful implementation requires a thorough understanding of its impacts on assay performance. In this perspective, we review recent case studies comparing singlicate and duplicate formats, focusing on cut point factors and sample result agreement, and seek to discuss how singlicate influences assay cut points and explore considerations for low positive control criteria under singlicate conditions. Furthermore, we propose a strategy for implementing singlicate analysis in both new and existing ADA assays, hoping to contribute to ongoing discussions in this area.
BioanalysisBIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL
CiteScore
3.30
自引率
16.70%
发文量
88
审稿时长
2 months
期刊介绍：
Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing.
The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality.
Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing.
The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques.
Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
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