Performance of the pooled testing strategy for detecting and estimating the prevalence and intensity of Schistosoma haematobium infection at a population level

项目总结 血吸虫影响世界上超过1.12亿人，主要在撒哈拉以南非洲和 在中东，导致泌尿生殖系统血吸虫病和这些地区大多数膀胱癌病例 区域1-4缺乏成本效益高的检测病例的诊断战略，估计 感染患病率、吡喹酮(PZQ)疗效和大规模给药(MDA)评价 项目在控制这种寄生虫感染方面的有效性。一种称为分组的创新程序 测试，也称为池测试，已被用于通过减少数量来节省资源和时间 用于诊断不同传染病的测试。5-8长期目标是开发一种 标准化的、可重复的方案，并指导对尿样汇集结果的解释 准确诊断血吸虫感染，成本低，周转时间短。整体而言 目的是评估用于检测存在和 估计感染的流行率和强度。中心假设是，共享提供了更多 为感染的诊断做出具有成本效益的决策，具有可靠的敏感性。这样做的理由是 该项目的目的是，及时和成本效益高、可靠的血吸虫诊断战略将(1)迅速帮助 筛查样本，特别是在低流行率环境中，以及(2)估计 感染评估和计划针对疾病的控制方案。在第一个目标下，苏云金杆菌 感染将在不同的池大小、尿量、感染强度和/或不同的情况下进行检查 诊断测试，以确定可检测到寄生虫的池大小以及尿量 以及以可靠的敏感度最佳诊断寄生虫的测试。对于第二个目标，最佳池大小 将确定每个研究地区/村庄可产生的最小预期集合测试次数，并 申请在疫区进行大规模的感染流行病学调查。在第三个目标中， 个别样本检测结果将估计血瘤链球菌感染的流行率和强度 将进行比较，并将进行汇集测试方法的成本效益分析。这 提出的研究是创新的，因为它将应用实验研究来验证池的大小， 尿量、感染强度和敏感的诊断方法。 血吸虫感染，并确定每个区域的最佳池大小。混合尿样检测 将大规模应用检测感染和估计感染流行程度和强度， 首次进行临床调查。成本效益分析将首先确认合并测试是否将 保存诊断血瘤链球菌的资源。结果将澄清何时以及如何汇集 尿样可以在大规模流行病学调查中转化为重要的成本节约 评估感染的流行率，评估PZQ的疗效，并监测MDA项目的进展。

PROJECT SUMMARY Schistosoma haematobium affects more than 112 million people in the world, mainly in sub-Saharan Africa and the Middle East, causing urogenital schistosomiasis and the majority of bladder cancer cases in these regions.1-4 There is a lack of cost-effective diagnostic strategies for detecting cases, estimation of infection prevalence, and evaluation of praziquantel (PZQ) efficacy and mass drug administration (MDA) programs' effectiveness for controlling this parasitic infection. An innovative procedure called group testing, also known as pooled testing, has been used to save resources and time by reducing the number of tests for the diagnosis of different infectious diseases.5-8 The long-term goal is to develop a standardized, reproducible protocol and to guide interpretation of results for pooling urine samples to accurately diagnose S. haematobium infection at low cost and in short turnaround time. The overall objective is to evaluate the performance and cost of the pooling strategy for detecting the presence and estimating the prevalence and intensity of infection. The central hypothesis is that pooling provides more cost-effective decision making for the diagnosis of infection at a reliable sensitivity. The rationale for this project is that a timely and cost-effective reliable S. haematobium diagnostic strategy will (1) help rapidly screen samples, particularly in low prevalence settings, and (2) estimate the prevalence and intensity of infection to evaluate and plan control programs against the disease. Under the first aim, S. haematobium infection will be examined in different pool sizes, volumes of urine, the intensity of infection, and/or different diagnostic tests to determine the pool sizes where the parasite can be detected, as well as the volume of urine and tests that best diagnose the parasite at a reliable sensitivity. For the second aim, the optimal pool size that can yield the smallest expected number of pooled tests for each study area/village will be determined and applied for a large-scale epidemiological survey of infection in endemic regions. In the third aim, the prevalence and intensity of S. haematobium infection will be estimated, individual samples testing results will be compared, and a cost-benefit analysis for the pooled testing approach will be conducted. This research proposed is innovative because it will apply an experimental study to validate pool size, the volume of urine, the intensity of infection and sensitive diagnostic methods for the examination of S. haematobium infection and define optimal pool size for each region. The pooled urine sample test for detecting infection and estimation of prevalence and intensity of infection will be applied in a large-scale, clinical survey for the first time. The cost-benefit analysis will be the first to confirm if pooled testing will conserve resources for the diagnosis of S. haematobium. The results will clarify when and how pooling urine samples could translate into important cost-savings in large-scaled epidemiological surveys to assess the prevalence of infection, gauge PZQ efficacy, and monitor the progress of MDA programs.