Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries

Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries
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DOI:
10.1371/journal.pntd.0007446
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发表时间:
2019-08-01
影响因子:
3.8
通讯作者:
Levecke, Bruno
Levecke, Bruno
中科院分区:
医学2区
文献类型:
--
作者:
Cools, Piet;Vlaminck, Johnny;Levecke, Bruno

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背景由于针对土传蠕虫(STH)的驱虫计划的成功是通过定期评估流行率和感染强度来评估的,因此使用正确的诊断方法是至关重要的。STH社区最近为驱虫计划的每个阶段发布了潜在诊断方法需要满足的最低标准,即所谓的目标产物轮廓(TPP)。方法在埃塞俄比亚、老挝和坦桑尼亚的三项药物疗效试验中,我们比较了单一Kato-Katz(参考法)与其他基于显微镜的方法(复制Kato-Katz、Mini-FLOTAC和FECPAK(G2))和一种基于DNA的方法(QPCR)检测和量化STH感染的诊断性能。此外,我们还对TPP最低诊断标准的选择进行了评估。主要发现所有诊断方法对所有中到重度STH感染的临床敏感性均为>=90%。对于极低强度的感染,只有qPCR对所有STH的敏感性高于单一加藤-卡茨方法。与参考方法相比,Mini-FLOTAC和FECPAK(G2)均导致某些STH的粪卵计数显著减少,导致对感染强度的严重低估。对于qPCR,单个Kato-Katz的虫卵计数与DNA浓度之间存在显著正相关。结论/意义我们的结果表明,社区低估了单个Kato-Katz的诊断能力,并且Mini-FLOTAC、FECPAK(G2)和qPCR的诊断特异性阈值是必要的。当我们严格应用TPP时,Kato-Katz是唯一满足STH计划规划、监测和评估阶段应用的最低诊断标准的基于显微镜的方法。在寻求确认停止计划的阶段,qPCR是唯一可以考虑的方法。
BackgroundBecause the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence and infection intensities, the use of the correct diagnostic method is of utmost importance. The STH community has recently published for each phase of a deworming program the minimal criteria that a potential diagnostic method needs to meet, the so-called target product profiles (TPPs).MethodologyWe compared the diagnostic performance of a single Kato-Katz (reference method) with that of other microscopy-based methods (duplicate Kato-Katz, Mini-FLOTAC and FECPAK(G2)) and one DNA-based method (qPCR) for the detection and quantification of STH infections in three drug efficacy trials in Ethiopia, Lao PDR, and Tanzania. Furthermore, we evaluated a selection of minimal diagnostic criteria of the TPPs.Principal findingsAll diagnostic methods showed a clinical sensitivity of >= 90% for all STH infections of moderate-to-heavy intensities. For infections of very low intensity, only qPCR resulted in a sensitivity that was superior to a single Kato-Katz for all STHs. Compared to the reference method, both Mini-FLOTAC and FECPAK(G2) resulted in significantly lower fecal egg counts for some STHs, leading to a substantial underestimation of the infection intensity. For qPCR, there was a positive significant correlation between the egg counts of a single Kato-Katz and the DNA concentration.Conclusions/SignificanceOur results indicate that the diagnostic performance of a single Kato-Katz is underestimated by the community and that diagnostic specific thresholds to classify intensity of infection are warranted for Mini-FLOTAC, FECPAK(G2) and qPCR. When we strictly apply the TPPs, Kato-Katz is the only microscopy-based method that meets the minimal diagnostic criteria for application in the planning, monitoring and evaluation phase of an STH program. qPCR is the only method that could be considered in the phase that aims to seek confirmation for cessation of program.