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.

项目概要 埃及血吸虫影响着全世界超过 1.12 亿人，主要分布在撒哈拉以南非洲和 中东地区，导致泌尿生殖系统血吸虫病和大多数膀胱癌病例 1-4 缺乏具有成本效益的诊断策略来发现病例、估计 感染率、吡喹酮 (PZQ) 疗效评估和大规模给药 (MDA) 程序控制这种寄生虫感染的有效性。一种称为组的创新程序 测试，也称为集中测试，已被用于通过减少测试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、可重复的方案并指导汇集尿液样本的结果解释 以低成本和短周转时间准确诊断埃及沙门氏菌感染。整体 目标是评估池化策略的性能和成本，以检测是否存在和 估计感染的流行率和强度。中心假设是池化提供了更多 以可靠的灵敏度做出具有成本效益的感染诊断决策。这样做的理由 项目的重点是及时且具有成本效益的可靠埃及沙门氏菌诊断策略将 (1) 快速提供帮助 筛查样本，特别是在低流行率环境中，以及 (2) 估计流行率和强度 感染来评估和规划针对该疾病的控制计划。在第一个目标下，埃及沙门氏菌 将在不同的池大小、尿液量、感染强度和/或不同的条件下检查感染情况。 诊断测试以确定可以检测寄生虫的池大小以及尿液量 以及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 将确定可以产生每个研究区域/村庄的最小预期汇总测试数量，并且 申请开展流行地区大规模感染流行病学调查。在第三个目标中， 将估计埃及沙门氏菌感染的流行率和强度，个别样本检测结果 将进行比较，并对汇总测试方法进行成本效益分析。这 提出的研究具有创新性，因为它将应用实验研究来验证池大小、 尿量、感染强度和检查金黄色葡萄球菌的敏感诊断方法。 埃及人感染并确定每个区域的最佳库大小。合并尿液样本测试 检测感染并估计感染流行率和强度将被大规模应用， 首次进行临床调查。成本效益分析将首先确认集中测试是否会 保存埃及沙门氏菌的诊断资源。结果将阐明何时以及如何汇集 尿液样本可以在大规模流行病学调查中节省大量成本， 评估感染流行率、评估 PZQ 疗效并监测 MDA 计划的进展。