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抗药抗体对胰岛素定量的干扰：液相色谱-串联质谱法与免疫分析法的比较

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

作者信息

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

机构信息

Analytical Chemistry Group, Department of Plant & Environmental Science, Faculty of Science, University of Copenhagen, Frederiksberg C, DK-1871, Denmark.

Non-clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Novo Nordisk A/S Måløv, DK-2760, Denmark.

出版信息

Bioanalysis. 2024 Sep 12;16(17-18):1-11. doi: 10.1080/17576180.2024.2389637.

DOI:10.1080/17576180.2024.2389637
PMID:39262387
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11485705/
Abstract

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. 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. 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.

摘要

本研究旨在比较不同平台（AlphaLISA、Gyrolab、液相色谱-串联质谱法）上四种药代动力学（PK）分析方法中抗药抗体（ADA）的干扰情况，并设计一种减轻ADA干扰的策略，以提高总PK分析中所测药物的准确性。在含有胰岛素类似物的人血清中制备了达到不同ADA浓度的加标测试样品，并与混合临床样品一起使用四种分析方法进行分析。在所有平台上均观察到干扰。一种使用Gyrolab混合CD的新方法，包括在PK分析中进行酸解离，显著降低了干扰，从而将相对误差从>99%降低至≤20%，使测量结果完全符合接受标准。临床样品结果强化了测试样品的研究结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/08fbde9a91e5/IBIO_A_2389637_F0003_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/d8d72586a097/IBIO_A_2389637_UF0001_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/be36c47875f3/IBIO_A_2389637_F0001_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/64c6e5dc330d/IBIO_A_2389637_F0002_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/08fbde9a91e5/IBIO_A_2389637_F0003_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/d8d72586a097/IBIO_A_2389637_UF0001_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/be36c47875f3/IBIO_A_2389637_F0001_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/64c6e5dc330d/IBIO_A_2389637_F0002_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ff/11485705/08fbde9a91e5/IBIO_A_2389637_F0003_C.jpg

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本文引用的文献

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Cell Metab. 2021 Apr 6;33(4):740-747. doi: 10.1016/j.cmet.2021.03.014.
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Generic multicriteria approach to determine the best precipitation agent for removal of biomacromolecules prior to non-targeted metabolic analysis.通用多准则方法，用于确定在非靶向代谢分析之前去除生物大分子的最佳沉淀剂。
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一种通过液相色谱-高分辨质谱法（LC-MS/HRMS）定量测定血浆和死后血清中人类胰岛素及其合成类似物的方法的开发与验证。
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Development of an UPLC/MS-MS method for quantification of intact IGF-I from human serum.开发一种用于定量测定人血清中完整胰岛素样生长因子-I（IGF-I）的超高效液相色谱/串联质谱（UPLC/MS-MS）方法。
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Recent advances in the determination of insulins from biological fluids.生物体液中胰岛素的测定方法的最新进展。
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