Interference from anti-drug antibodies on the quantification of insulin: a comparison of an LC-MS/MS assay and immunoassays.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-09-12 DOI:10.1080/17576180.2024.2389637

Georgina Marta Varga, Manca Spendal, Jens Sigh, Tue Søeborg, Nikoline Juul Nielsen

引用次数: 0

Abstract

Aim: This study aims to compare the anti-drug antibody (ADA) interference in four pharmacokinetic (PK) assays across different platforms (AlphaLISA, Gyrolab, LC-MS/MS) and to devise a strategy for ADA interference mitigation to improve the accuracy of measured drug in total PK assays.Materials & methods: Spiked test samples, created to achieve different ADA concentrations in human serum also containing an insulin analogue, were analyzed alongside pooled clinical samples using four assays.Results & conclusion: Interference was observed in all platforms. A novel approach using the Gyrolab mixing CD, including acid dissociation in the PK assay, significantly reduced interference and thereby improved relative error from >99% to ≤20% yielding measurements well within the acceptance criteria. Clinical sample results reinforced findings from the test samples.

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抗药性抗体对胰岛素定量的干扰：LC-MS/MS 检测法与免疫测定法的比较。

目的：本研究旨在比较不同平台（AlphaLISA、Gyrolab、LC-MS/MS）的四种药代动力学（PK）测定中的抗药物抗体（ADA）干扰，并设计一种减轻 ADA 干扰的策略，以提高总 PK 测定中药物测量的准确性：使用四种检测方法分析加标测试样本，以获得人血清中不同浓度的 ADA（同时含有一种胰岛素类似物），并同时分析汇集的临床样本：结果与结论：所有平台都观察到了干扰。使用 Gyrolab 混合 CD 的新方法（包括 PK 检测中的酸解离）大大减少了干扰，从而将相对误差从大于 99% 降至小于 20%，测量结果完全符合验收标准。临床样本的结果证实了测试样本的结论。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

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.