Development and validation of highly sensitive ligand binding assay to measure soluble DLL3 concentration in human serum.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-24 DOI:10.1080/17576180.2025.2518047

Masanobu Nishidate, Chisato Yanagisawa, Hiroki Irie, Kayo Aida, Takashi Miyayama, Kimio Terao

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引用次数: 0

Abstract

Background: Delta-like protein 3 (DLL3) is considered to inhibit the Notch pathway in the tumorigenesis of small cell lung cancer (SCLC) and other neuroendocrine carcinomas, making it a potential therapeutic target in the treatment of cancer. Since the soluble form (sDLL3) is expected to be useful for predicting the status of DLL3 expression on tumors, analytical methods to measure sDLL3 are required.

Research design and methods: Assay methods using ELISA and the SMCxPRO platform were developed to analyze sDLL3 concentration in human serum. The performance of the ELISA was evaluated and the SMCxPRO assay was fully validated, and the comparability of the 2 assays was assessed.

Results: The performance of the ELISA was acceptable, and in the SMCxPRO assay validation, all pre-defined validation acceptance criteria were met. The 2 assays were comparable within the range of quantification. Concentrations ranged from below the limit of quantification (<1.00 pg/mL) to 18.0 pg/mL for healthy volunteers and from 1.27 pg/mL to 519 pg/mL for SCLC patients by SMCxPRO assay.

Conclusions: Two sensitive assay methods to measure sDLL3 in human serum were successfully established. These assays have potential as novel blood-based assays to assess the status of DLL3 expression on tumors in humans.

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高灵敏度配体结合测定法测定人血清中可溶性DLL3浓度的建立与验证。

背景：Delta-like protein 3 （DLL3）被认为在小细胞肺癌（SCLC）等神经内分泌癌的肿瘤发生过程中抑制Notch通路，是治疗癌症的潜在靶点。由于可溶性形式（sDLL3）有望用于预测DLL3在肿瘤中的表达状态，因此需要测量sDLL3的分析方法。研究设计与方法：建立了ELISA和SMCxPRO平台检测人血清中sDLL3浓度的方法。对ELISA的性能进行评价，对SMCxPRO检测方法进行充分验证，并对两种检测方法的可比性进行评价。结果：该酶联免疫吸附试验性能可接受，在SMCxPRO检测验证中，符合所有预先设定的验证接受标准。两种测定方法在定量范围内具有可比性。结论：成功建立了两种灵敏的测定人血清中sDLL3的方法。这些检测方法有潜力作为一种新的基于血液的检测方法来评估DLL3在人类肿瘤中的表达状态。

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.