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: 10453270
• 负责人: Abraham Mengist
• 金额: $ 23.13万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10453270
• 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; base; 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 血吸虫血吸虫病影响着世界上超过1.12亿人，主要在撒哈拉以南非洲和 中东引起泌尿生殖血吸虫病和大多数膀胱癌病例 区域1-4缺乏检测病例的具有成本效益的诊断策略，估计 感染率和评估Praziquantel（PZQ）疗效和大众药物给药（MDA） 计划控制这种寄生虫感染的有效性。一种创新的程序，称为Group 测试（也称为汇总测试）已用于通过减少数字来节省资源和时间 5-8的长期目标是开发一个 标准化，可重复的方案，并指导将尿液样品汇集结果解释 准确地诊断出低成本和短时间的止血链球菌感染。总体 目的是评估合并策略的性能和成本，以检测存在和 估计感染的患病率和强度。中心假设是合并提供了更多 以可靠的灵敏度诊断感染的成本效益决策。理由 项目是，及时且具有成本效益的可靠S. haematobium诊断策略将（1）迅速帮助 屏幕样本，特别是在低患病率的情况下，（2）估计的患病率和强度 感染以评估和计划针对该疾病的控制计划。在第一个目标下，haematobium 感染将以不同的池尺寸，尿量，感染强度和/或不同的方式检查 诊断测试以确定可以检测到寄生虫的池大小以及尿液的体积 并测试最能以可靠的灵敏度诊断寄生虫的测试。对于第二个目标，最佳池尺寸 可以确定每个研究区域/村庄的预期汇总测试数量最少，并且 申请了对流行地区感染的大规模流行病学调查。在第三个目标中 将估计止血链球菌感染的患病率和强度，单个样品测试结果 将进行比较，并将对合并测试方法进行成本效益分析。这 提出的研究具有创新性，因为它将采用实验研究来验证池大小， 尿量，感染的强度和敏感的诊断方法检查。 止血物感染并定义每个区域的最佳池尺寸。合并的尿液样品测试 检测感染和感染强度的估计将在一个大规模上应用 第一次临床调查。成本效益分析将是第一个确认合并测试是否会 保存用于诊断出血肿的资源。结果将阐明何时以及如何汇总 尿液样本可以转化为大规模流行病学调查中的重要成本储蓄 评估感染，量表PZQ功效的患病率，并监测MDA计划的进度。