Evaluation of 1^st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform.

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals Pub Date : 2025-08-06 DOI:10.1016/j.biologicals.2025.101850

Bhagwati Khatri, Peggy Riese, Hanna Shkarlet, Daniella Mortier, Helen McShane, Paul W Bowyer, Edmond Remarque

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引用次数: 0

Abstract

This study focuses on harmonising the competition ELISA (cELISA) assay for Plasmodium falciparum (P. falciparum), using the 1st WHO reference reagent for anti-malaria (P. falciparum) human reference serum (10/198). Antibody-mediated immune responses against the Apical Membrane Antigen 1 (AMA1) play a significant role in protection against malaria. However, the sequence diversity of AMA1 and cross-reactivity among variants pose challenges in assessing antibody responses. To address this, the cELISA assay was selected to examine cross-reactive antibody responses against different variants. The harmonisation process for cELISA was performed in three laboratories. The 10/198 served as an internal standard for the calculation of IgG concentrations in the cELISA using ADAMSEL software. Additionally, a novel semi-automated analytical tool was developed in the R-statistics environment. This tool is freely available for download and streamlines generating results while minimising human error. This study demonstrated the effectiveness of the 1st WHO reference reagent as a standard for cELISA. Additionally, the ADAMSEL software and R-platform tool provide a user-friendly and accessible tool for the analysis of cELISA data. Its automation capabilities improve efficiency and ensure global accessibility at no cost, benefitting laboratories with limited resources.

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世界卫生组织首个抗疟疾竞争性ELISA标准试剂评价及ADAMSEL分析平台开发。

本研究的重点是统一恶性疟原虫（P. falciparum）竞争ELISA （cELISA）检测方法，使用世界卫生组织第一个抗疟疾（P. falciparum）人参考血清标准试剂（10/198）。针对顶膜抗原1 （AMA1）的抗体介导的免疫应答在疟疾保护中发挥重要作用。然而，AMA1的序列多样性和变体之间的交叉反应性给评估抗体反应带来了挑战。为了解决这个问题，我们选择了cELISA检测来检测针对不同变体的交叉反应性抗体反应。cELISA的协调过程在三个实验室进行。10/198作为内标，使用ADAMSEL软件计算cELISA中IgG浓度。此外，在R-statistics环境中开发了一种新的半自动分析工具。此工具可免费下载，并简化生成结果，同时最大限度地减少人为错误。本研究证明了世卫组织第一种参比试剂作为cELISA标准试剂的有效性。此外，ADAMSEL软件和r平台工具为分析cELISA数据提供了一个用户友好且易于访问的工具。它的自动化能力提高了效率，并确保全球免费访问，使资源有限的实验室受益。

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

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

期刊介绍： Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.