一种新的尿抗原检测快速诊断方法的准确性及对蛇胸腺病药物治疗的评估。

IF 8.1 1区 医学 Infectious Diseases of Poverty Pub Date : 2023-11-21 DOI:10.1186/s40249-023-01162-4
Chanika Worasith, Jiraporn Sithithaworn, Phattharaphon Wongphutorn, Chutima Homwong, Kanoknan Khongsukwiwat, Anchalee Techasen, Kulthida Y Kopolrat, Watcharin Loilome, Nisana Namwat, Bandit Thinkamrop, Chaiwat Tawarungruang, Attapol Titapun, Thewarach Laha, Ross H Andrews, Simon D Taylor-Robinson, Paiboon Sithithaworn
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引用次数: 0

摘要

背景:血吸虫病是一种影响东南亚数百万人的寄生虫感染,其筛查传统上依赖于粪卵检查,如福尔马林-乙酸乙酯浓度技术(FECT)和Kato-Katz方法。虽然尿酶联免疫吸附试验(ELISA)最近被广泛使用,但我们开发了一种基于尿液抗原的快速诊断试验(RDT),以简化诊断,并作为一种即时检测(POCT)和现场应用,用于监测和控制蛇胸蚴病。方法:采用免疫层析方法,用特异性单克隆抗体制备尿尿viverrini Opisthorchis (OV) rdt。比较尿液OV-RDT与定量粪便效应和尿抗原ELISA的诊断效能(n = 493)。测定尿液OV-RDT与其他与粪胞弧菌共存的蠕虫病的交叉反应性(n = 96)。在一项应用尿液OV-RDT的现场试验中,比较了尿抗原ELISA在基础筛选和评估阿片胸蚴病药物治疗结果方面的应用(n = 1629)。采用McNemar卡方检验、Kruskal-Wallis检验和Cohen’s kappa系数(κ值)检验进行统计分析。结果:尿液OV-RDT与粪便FECT相比,敏感性为94.2%,特异性为93.2%。尿OV-RDT诊断一致性较高(Kappa = 0.842 ~ 0.874, p0.8, p0.05)。结论:尿液OV-RDT检测具有很高的潜力,可作为一种筛查和评价蛇胸片病治疗效果的新工具。尿液OV-RDT的样本采集方便和简便,可能有助于大规模筛查、控制和消除蛇胸片病,从而有助于减轻东南亚的疾病负担。
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Accuracy of a new rapid diagnostic test for urinary antigen detection and assessment of drug treatment in opisthorchiasis.

Background: Screening for opisthorchiasis, a parasitic worm infection affecting many millions of people in Southeast Asia, has traditionally relied on faecal egg examination such as the formalin-ethyl acetate concentration technique (FECT) and Kato-Katz method. Although the urinary enzyme-linked immunosorbent assay (ELISA) has been used more recently, we developed a urinary antigen-based rapid diagnostic test (RDT) to simplify diagnosis and as a point-of-care testing (POCT) and field applications for surveillance and control of opisthorchiasis.

Methods: A urinary Opisthorchis viverrini (OV)-RDT was developed using immunochromatographic methodology with a specific monoclonal antibody against OV. The diagnostic performance of the urinary OV-RDT was compared to that of quantitative faecal FECT and urinary antigen ELISA (n = 493). Cross-reactivities of urinary OV-RDT with other helminthiases coexisted with O. viverrini were determined (n = 96). A field trial in the application of urinary OV-RDT was compared with urinary antigen ELISA at baseline screening and assessment of drug treatment outcomes in opisthorchiasis (n = 1629). The McNemar chi-square, Kruskal-Wallis and Cohen's kappa coefficient (κ-value) tests were used for statistical analyses.

Results: Urinary OV-RDT had sensitivity of 94.2% and specificity of 93.2%, compared to faecal FECT. Urinary OV-RDT had high diagnostic agreement (Kappa = 0.842-0.874, P < 0.001) and quantitative correlation with urinary antigen ELISA (Kruskal-Wallis tests = 316.2, P < 0.0001) and faecal FECT (Kruskal-Wallis tests = 362.3, P < 0.0001). The positive rates by OV-RDT, ELISA and FECT were 48.9%, 52.5% and 49.3%, respectively. Cross-reactions of urinary OV-RDT with other helminthiases were few (2%). Field trials of urinary OV-RDT yielded comparable prevalence of O. viverrini between urinary OV-RDT (53.2%) and urinary antigen ELISA (54.0%). OV screening showed high diagnostic agreement (kappa > 0.8, P < 0.0001) between urinary OV-RDT and urinary antigen ELISA. The cure rates of opisthorchiasis at 1 month post-praziquantel treatment determined by urinary OV-RDT (86.6%) and urinary antigen ELISA (80.5%) were similar (P > 0.05).

Conclusions: The urinary OV-RDT test has high potential as a new tool for screening and evaluating treatment outcomes in opisthorchiasis. The ease of sample collection and simplicity of urinary OV-RDT may facilitate mass screening, control and elimination of opisthorchiasis, thereby contributing to a reduction in the disease burden in Southeast Asia.

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来源期刊
Infectious Diseases of Poverty
Infectious Diseases of Poverty INFECTIOUS DISEASES-
自引率
1.20%
发文量
368
期刊介绍: Infectious Diseases of Poverty is an open access, peer-reviewed journal that focuses on addressing essential public health questions related to infectious diseases of poverty. The journal covers a wide range of topics including the biology of pathogens and vectors, diagnosis and detection, treatment and case management, epidemiology and modeling, zoonotic hosts and animal reservoirs, control strategies and implementation, new technologies and application. It also considers the transdisciplinary or multisectoral effects on health systems, ecohealth, environmental management, and innovative technology. The journal aims to identify and assess research and information gaps that hinder progress towards new interventions for public health problems in the developing world. Additionally, it provides a platform for discussing these issues to advance research and evidence building for improved public health interventions in poor settings.
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