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

用于检测和估计人群水平埃及血吸虫感染流行率和强度的汇总检测策略的执行情况

• 批准号: 10597678
• 负责人: Abraham Mengist
• 金额: $ 18.51万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10597678
• 关键词: Affect; Africa South of the Sahara; Area; Clinical; Communicable Diseases; Cost Savings; Cost-Benefit Analysis; Data; Decision Making; Development; Diagnosis; Diagnostic Procedure; Diagnostic Sensitivity; Diagnostic tests; Disease; Effectiveness; Epidemiology; Evaluation; Genitourinary system; Goals; Healthcare; Individual; Infection; Investigation; Low Prevalence; Malignant neoplasm of urinary bladder; Middle East; Mission; Monitor; National Institute of Allergy and Infectious Disease; Online Systems; Outcome; Parasites; Parasitic infection; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Praziquantel; Prevalence; Procedures; Program Effectiveness; Protocols documentation; Public Health; Rapid screening; Reproducibility; Research; Resource Allocation; Resources; Sampling; Schistosoma; Schistosoma haematobium; Schistosomiasis; Specimen; Standardization; Surveys; Techniques; Test Result; Testing; Time; Translating; Urine; accurate diagnosis; combat; cost; cost effective; design; diagnostic strategy; diagnostic tool; drug efficacy; experimental study; innovation; population survey; prevent; programs; screening; tool

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.

项目摘要 埃及血吸虫影响世界上超过1.12亿人，主要在撒哈拉以南非洲， 中东，导致泌尿生殖道血吸虫病和大多数膀胱癌病例，在这些 地区。1 -4缺乏用于检测病例、估计病例的具有成本效益的诊断策略 吡喹酮（PZQ）疗效评价和大规模给药（MDA） 控制这种寄生虫感染的有效性。一个叫做小组的创新程序 测试，也称为池化测试，已经被用来通过减少测试的数量来节省资源和时间。 5 -8长期目标是开发一种用于诊断不同传染病的检测方法， 标准化、可重复的方案，并指导合并尿样结果的解释， 准确诊断S.以低成本和短的周转时间来控制感染。整体 目的是评估用于检测存在的池化策略的性能和成本， 估计感染的流行程度和严重程度。核心假设是，池化提供了更多 以可靠的灵敏度做出用于诊断感染的具有成本效益的决策。这样做的理由 项目是一个及时和具有成本效益的可靠的S。嗜血杆菌诊断策略将（1）快速帮助 筛查样本，特别是在低患病率环境中，以及（2）估计 评估和规划针对该疾病的控制方案。在第一个目标下，S.吸虫 感染将在不同的池大小、尿量、感染强度和/或不同的浓度下进行检查。 诊断测试，以确定池的大小，其中寄生虫可以检测，以及尿量 以及能以可靠的灵敏度最好地诊断寄生虫的测试。对于第二个目标，最佳池大小 将确定每个研究区域/村庄可产生最小预期合并测试数量的方法， 申请在流行地区进行大规模感染流行病学调查。在第三个目标中， S.将估计血吸虫感染，个体样本检测结果 将进行比较，并对合并测试方法进行成本效益分析。这 建议的研究是创新的，因为它将应用实验研究来验证游泳池的大小， 尿量、感染强度和敏感的诊断方法对检测S. 并确定每个区域的最佳池大小。合并尿液样本检测 检测感染和估计感染的流行和强度将大规模应用， 首次进行临床调查。成本效益分析将是第一个确认合并试验是否 为S.埃及血吸虫结果将阐明何时以及如何汇集 尿液样本可以转化为大规模流行病学调查的重要成本节约， 评估感染的流行率，衡量PZQ的疗效，并监测MDA项目的进展。