基于重组抗原的侧流试验检测粪圆线虫感染。

IF 3.4 2区医学 Q1 PARASITOLOGY

PLoS Neglected Tropical Diseases Pub Date : 2025-04-08 DOI:10.1371/journal.pntd.0013018

Robertine Lontuo-Fogang, Thomas B Nutman

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引用次数: 0

摘要

背景：类圆线虫病是一个严重的公共卫生问题，影响全世界数百万人，特别是在热带和亚热带地区。类圆线虫病的实验室诊断通常以血清学为基础，通常采用酶联免疫吸附试验（ELISA）。然而，在护理点使用这些检测需要明显不同的血清学测量方法。我们试图确定两种原型侧流测试和strong Detect elisa （IgG和IgG4）的诊断性能，该elisa使用两种ss特异性重组抗原Ss-NIE和Ss-IR的混合物。方法：采用17例健康志愿者、77例粪圆线虫（Ss）粪便阳性、44例Ss粪便阴性但罗阿罗阿虫（n=32）或其他蠕虫（n=12）（钩虫感染、曼氏血吸虫或班氏乌氏杆菌）粪便标本，测定快速诊断试验（RDTs）和elisa的诊断性能。采用Cohen’s kappa统计量（κ）计算rdt与elisa之间的一致性。结果：IgG RDT的敏感性和特异性为95% (95% CI；87.84 ~ 98.64%)和94% (95% CI；84.99 ~ 98.30%)。IgG4 RDT的敏感性为86.5% (95% CI；77.63 ~ 92.83%)和100% (95% CI；94.13至100%)特异性。基于igg的ELISA结果为100% (95% CI；95.6-100%)敏感性和96%特异性(95% CI；91.7-98%)，而基于igg4的ELISA显示为90% (95% CI；81-94.3%)的敏感性为100% (95% CI；97.8 -100%)特异性。rdt和elisa之间的一致性非常好，κ = 0.94 (95% CI；0.88-1.0%), κ = 0.89 (95% CI；0.81-0.97%)。结论：基于IgG和igg4的RDT具有高度的敏感性和特异性，它们中的任何一种都可用于基于人群的研究中评估Ss血清阳性和在接触点筛查患者。

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Recombinant antigen-based lateral flow tests for the detection of Strongyloides stercoralis infection.

Background: Strongyloidiasis is a serious public health issue affecting millions of people worldwide particularly in tropical and subtropical regions. The laboratory diagnosis of strongyloidiasis is often serologically based, typically by enzyme linked immunosorbent assays (ELISA). However, the use of these assays at the point of care requires significantly different approaches for serologic measurements. We sought to determine the diagnostic performance of 2 prototype lateral flow tests alongside the Strongy Detect ELISAs (IgG and IgG4) that uses a cocktail of 2 Ss-specific recombinant antigens, Ss-NIE and Ss-IR.

Methods: The diagnostic performance of the Rapid Diagnostic Tests (RDTs) and ELISAs was determined by using stored serum samples from 17 healthy volunteers, 77 individuals known to be stool positive for Strongyloides stercoralis (Ss), 44 Ss stool-negative individuals but positive for Loa loa (n=32), or other helminths (n=12) (hookworm infection, Schistosoma mansoni, or Wuchereria bancrofti). Concordance between the RDTs and ELISAs was calculated with the Cohen's kappa statistic (κ).

Results: The sensitivity and specificity of the IgG RDT was 95% (95% CI; 87.84 to 98.64%) and 94% (95% CI; 84.99 to 98.30%) respectively. The IgG4 RDT showed a sensitivity of 86.5% (95% CI; 77.63 to 92.83%) with 100% (95% CI; 94.13 to 100%) specificity. The IgG-based ELISA showed 100% (95% CI; 95.6-100%) sensitivity and 96% specificity (95% CI; 91.7-98%), whereas the IgG4-based ELISA revealed a 90% (95% CI; 81-94.3%) sensitivity with 100% (95% CI; 97.8-100%) specificity. Concordance between the RDTs and the ELISAs was excellent with κ = 0.94 (95% CI; 0.88-1.0%) for the IgGs and κ = 0.89 (95% CI; 0.81-0.97%) for IgG4 assays.

Conclusion: Given the high degree of sensitivity and specificity of both the IgG- and IgG4-based RDT, either of these would be useful in assessing Ss seropositivity in population-based studies and in screening patients at the point of contact.

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来源期刊

PLoS Neglected Tropical Diseases PARASITOLOGY-TROPICAL MEDICINE

自引率

10.50%

发文量

723

期刊介绍： PLOS Neglected Tropical Diseases publishes research devoted to the pathology, epidemiology, prevention, treatment and control of the neglected tropical diseases (NTDs), as well as relevant public policy. The NTDs are defined as a group of poverty-promoting chronic infectious diseases, which primarily occur in rural areas and poor urban areas of low-income and middle-income countries. Their impact on child health and development, pregnancy, and worker productivity, as well as their stigmatizing features limit economic stability. All aspects of these diseases are considered, including: Pathogenesis Clinical features Pharmacology and treatment Diagnosis Epidemiology Vector biology Vaccinology and prevention Demographic, ecological and social determinants Public health and policy aspects (including cost-effectiveness analyses).