Technical evaluation of the InBios Strongy Detect IgG ELISA assay for the diagnosis of Strongyloides stercoralis infection.

IF 3 2区医学 Q1 PARASITOLOGY

Parasites & Vectors Pub Date : 2024-12-23 DOI:10.1186/s13071-024-06501-4

Sara Roose, Marco Prato, Adama Kazienga, Iris Peelaers, Justien Arens, Gemechu Tadessa Leta, Cristina Mazzi, Dora Buonfrate, Bruno Levecke, Francesca Tamarozzi

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引用次数: 0

Abstract

Background: Strongyloidiasis is a neglected tropical disease (NTD) caused by the soil-transmitted helminth Strongyloides stercoralis, recently included in the 2030 targets of the World Health Organization for the control of STHs. Assessment of infection prevalence is fundamental for decision-making about the implementation of control programs, but diagnostic assays to be applied in such context require evaluation. Seroassays based on recombinant antigens, which could be produced in a standardized and scalable manner, are particularly appealing for use in control programs. In this study, we performed a technical evaluation of the InBios Strongy Detect IgG ELISA, based on recombinant antigens NIE and SsIR, which has shown promising for field use.

Methods: A total of 46 plasma samples from Ethiopian children were used for this technical evaluation. Repeatability was evaluated on duplicate samples per plate, on four plates per day for 3 days using Bland-Altman plots, analysis of residuals, and variance components analysis. Three samples were selected for evaluation of the uniformity of test results within a single plate (border effect) by two-sided t-test. Correlation between samples and internal ELISA positive controls was analyzed using Spearman's rank correlation coefficient applied on the results of 777 samples analyzed with the assay in a previous field-based study.

Results: Within and between plate residuals ranged from -0.05 to + 0.05 and -0.1 to + 0.1, respectively. Total variance was estimated at 0.327; 99.6% of variation could be attributed to the samples. There was no systematic border effect and a negligible correlation between positive internal control and samples results (R² = 0.213; p < 0.001).

Conclusion: The results obtained in this study, in highly controlled conditions, point toward the InBios Strongy Detect IgG ELISA assay being reproducible, with no systematic border effect. These results encourage further assay's development and evaluation for use in practice, including determination of preset cutoff values for positivity, which is currently not provided.

查看原文本刊更多论文

InBios强检测IgG ELISA法诊断粪类圆线虫感染的技术评价。

背景：类圆线虫病是一种被忽视的热带病（NTD），由土壤传播的粪类圆线虫引起，最近被列入世界卫生组织2030年控制类圆线虫的目标。对感染流行率的评估是实施控制规划决策的基础，但在这种情况下应用的诊断分析需要进行评估。基于重组抗原的血清分析，可以以标准化和可扩展的方式生产，特别适合用于控制计划。在这项研究中，我们对基于重组抗原NIE和SsIR的InBios强检测IgG ELISA进行了技术评估，该ELISA显示出在现场应用的前景。方法：采用来自埃塞俄比亚儿童的46份血浆样本进行技术评价。使用Bland-Altman图、残差分析和方差成分分析，对每个培养皿的重复样本进行重复性评估，每天4个培养皿，持续3天。选取3个样本，采用双侧t检验评价单板内检验结果的均匀性（边界效应）。样品与内部ELISA阳性对照之间的相关性采用Spearman等级相关系数，应用于先前现场研究中使用该方法分析的777个样品的结果。结果：板内和板间的残差范围分别为-0.05 ~ + 0.05和-0.1 ~ + 0.1。总方差估计为0.327；99.6%的变异可归因于样本。积极的内部控制与样本结果之间没有系统边界效应，相关性可以忽略不计(R2 = 0.213；结论：在高度控制的条件下，本研究获得的结果表明，InBios strong Detect IgG ELISA检测是可重复的，没有系统边界效应。这些结果鼓励进一步的分析开发和评估在实践中的使用，包括确定预设的阳性截止值，目前还没有提供。

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

Parasites & Vectors 医学-寄生虫学

CiteScore

6.30

自引率

9.40%

发文量

433

审稿时长

1.4 months

期刊介绍： Parasites & Vectors is an open access, peer-reviewed online journal dealing with the biology of parasites, parasitic diseases, intermediate hosts, vectors and vector-borne pathogens. Manuscripts published in this journal will be available to all worldwide, with no barriers to access, immediately following acceptance. However, authors retain the copyright of their material and may use it, or distribute it, as they wish. Manuscripts on all aspects of the basic and applied biology of parasites, intermediate hosts, vectors and vector-borne pathogens will be considered. In addition to the traditional and well-established areas of science in these fields, we also aim to provide a vehicle for publication of the rapidly developing resources and technology in parasite, intermediate host and vector genomics and their impacts on biological research. We are able to publish large datasets and extensive results, frequently associated with genomic and post-genomic technologies, which are not readily accommodated in traditional journals. Manuscripts addressing broader issues, for example economics, social sciences and global climate change in relation to parasites, vectors and disease control, are also welcomed.