Rapid and Simple Paper Diagnostic Test to Detect Enteric Pathogens in the Developing World

快速、简单的纸质诊断测试可检测发展中国家的肠道病原体

• 批准号: 10599023
• 负责人: Kelly K Baker
• 金额: $ 27.02万
• 依托单位: GODX, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10599023
• 关键词: 5 year old; Age; Antibiotics; Bangladesh; Bangladeshi; Biological Assay; Campylobacter; Campylobacter jejuni; Cause of Death; Cessation of life; Child; Cholera; Clinic; Clinical; DNA; Detection; Deterioration; Development; Devices; Diagnostic; Diagnostic tests; Diarrhea; Disease; Disease Outbreaks; Dysentery; Etiology; Evaluation; Feces; Freezing; Gastroenteritis; Gastrointestinal Diseases; Goals; Government; Health; Hospitals; Infection; Knowledge; Laboratories; Low Income Population; Low income; Measures; Methods; Microbiology; Microspheres; Molecular; Neighborhoods; Nucleic Acid Probes; Nucleic Acids; Outcome; Paper; Patients; Phase; Preparation; Prevalence; Public Health; Quality of Care; RNA; Records; Refugees; Reproducibility; Resources; Salmonella; Salmonella enterica; Sampling; Sensitivity and Specificity; Shigella; Shigella flexneri; Shigella sonnei; Silicon Dioxide; Specificity; System; Testing; Time; Validation; Vibrio cholerae; Viral; World Health Organization; amplification detection; biobank; burden of illness; co-infection; cost; cost effective; cost efficient; design; detection limit; detection test; diagnostic assay; diarrheal disease; emerging pathogen; enteric pathogen; expedited review; gastrointestinal; health care service utilization; health care settings; improved; innovation; instrumentation; low income country; mortality; novel; nucleic acid detection; participant enrollment; pathogen; point of care; rural area; stool sample; success; test strip; tool; treatment center; virology

Project Summary According to the World Health Organization, there are 1.7 billion cases of gastroenteritis every year and approximately 1.5 million children deaths. Diarrheal disease is the second leading cause of death in children under five years of age, mostly in the developing world. A wide-range of bacterial, viral, and parasitic pathogens can cause disease, with co-infections being common in low income countries with high disease burden. Clinical determination of therapy in resource- limited healthcare settings is frequently performed without etiological knowledge. As a result, antibiotics are overprescribed and poorly targeted, and infections caused by pathogens with high mortality rates may not be given adequate quality of care. Diagnostic testing for these pathogens is inconsistent because detection of these common pathogens traditionally requires transporting patients or patient samples, possibly over long distances, to a limited number of diagnostic laboratories, and then performing multiple tests across microbiology, virology, and molecular laboratories. Results may not be available for several days during which patients’ conditions may deteriorate without appropriate treatment. The rapid identification of pathogens that cause infectious diarrheal disease at the point-of-care may save lives and improve health outcomes by enabling prompt and appropriate treatment. Potential users in the developing world could include tertiary clinics in rural areas or urban low-income populations with low health care utilization and national public health field officers who investigate outbreaks. The goal of our project is to determine the feasibility of developing an innovative paper strip test that can integrate the steps of low cost, simple stool sample preparation and concentration method using hollow silica microspheres for total nucleic acid capture with multiplexed nucleic acid amplification and detection on a paper strip device. We will test 600 stool samples from patients enrolled in an ongoing study of GI disease in low-income neighborhoods of Bangladesh where the prevalence of infection by pathogens like Cholera, Salmonella, Shigella, Campylobacter is high. Success in this project can have broad impact in the development of other simple, point- of-care differential detection tests for pathogens causing other diseases in other sample types.

项目摘要 根据世界卫生组织的说法，每一个有17亿例胃炎病例 年份和约150万儿童死亡。腹泻病是第二大领先 五岁以下儿童的死亡原因，主要是在发展中国家。大范围 细菌，病毒和寄生虫病原体可能引起疾病，共同感染很常见 在低收入国家，伯恩疾病。资源治疗的临床确定 有限的医疗保健环境经常在没有病因知识的情况下进行。因此， 抗生素的定制过多且靶向较差，并且由病原体引起的感染 高死亡率可能不会给予足够的护理质量。这些 病原体是不一致的，因为传统上需要检测这些常见病原体 将患者或患者样本运输，可能会在很长的距离上运输到有限的数量 诊断实验室，然后在微生物学，病毒学和 分子实验室。结果可能无法在患者的几天内获得 条件可能在没有适当治疗的情况下决定。病原体的快速鉴定 这会在护理点上引起感染性腹泻病，可以挽救生命并改善健康状况 通过启用及时且适当的治疗来取得结果。开发中的潜在用户 世界可能包括农村地区的三级诊所或健康低收入人群 调查暴发的护理利用和国家公共卫生现场官员。目标 我们的项目是确定开发创新纸条测试的可行性，该测试可以 使用低成本，简单的粪便样品制备和浓度方法的步骤进行了整合 空心二氧化硅微球以多核核酸捕获总核酸 在纸条设备上放大和检测。我们将对患者测试600个粪便样品 在孟加拉国低收入社区的胃肠道疾病进行的一项正在进行的研究中 霍乱，沙门氏菌，志贺氏菌，弯曲杆菌等病原体感染的患病率是 高的。该项目的成功可能会对其他简单，点的发展产生广泛的影响 - 病原体的病原体差异检测测试，导致其他样本类型中的其他疾病。