Saloumeh K Fischer, Xiaome Xu, Hayeun Ji, Bingqing Zhang, Jeongsup Shim
{"title":"Pharmacokinetic analysis using single dilution assays: enhancing precision, reducing errors and increasing throughput.","authors":"Saloumeh K Fischer, Xiaome Xu, Hayeun Ji, Bingqing Zhang, Jeongsup Shim","doi":"10.1080/17576180.2025.2451520","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Technologies such as ELISA, MSD, and Gyrolab have been employed for quantifying protein therapeutics in clinical trials. However, these technologies have limitations with dynamic range often requiring multiple dilution steps, introducing potential errors and variability.</p><p><strong>Results/methodology: </strong>A pharmacokinetics assay was successfully developed on the NUcleic acid Linked Immuno-Sandwich Assay (NULISA) platform with a concentration dynamic range exceeding 6 logs. This enabled assessment of all clinical samples across different concentrations with a single dilution, yielding results with good correlation to ELISA and Gyrolab.</p><p><strong>Conclusions: </strong>NULISA technology offers high sensitivity, full automation, and a wide dynamic range, streamlining assay development and optimization, simplifying sample analysis, minimizing errors, and increasing throughput.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"41-47"},"PeriodicalIF":1.9000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749389/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bioanalysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17576180.2025.2451520","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/9 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Technologies such as ELISA, MSD, and Gyrolab have been employed for quantifying protein therapeutics in clinical trials. However, these technologies have limitations with dynamic range often requiring multiple dilution steps, introducing potential errors and variability.
Results/methodology: A pharmacokinetics assay was successfully developed on the NUcleic acid Linked Immuno-Sandwich Assay (NULISA) platform with a concentration dynamic range exceeding 6 logs. This enabled assessment of all clinical samples across different concentrations with a single dilution, yielding results with good correlation to ELISA and Gyrolab.
Conclusions: NULISA technology offers high sensitivity, full automation, and a wide dynamic range, streamlining assay development and optimization, simplifying sample analysis, minimizing errors, and increasing throughput.
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.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
