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.

项目概要 据世界卫生组织统计，每年有 17 亿肠胃炎病例 每年约有 150 万儿童死亡，腹泻病是第二大疾病。 五岁以下儿童的死亡原因，主要发生在发展中国家。 细菌、病毒和寄生虫病原体均可引起疾病，合并感染很常见 疾病负担高的低收入国家的资源治疗的临床确定。 因此，经常在没有病因学知识的情况下进行有限的医疗保健设置。 抗生素滥用且针对性不强，病原体引起的感染 高死亡率可能无法得到足够的护理质量。 病原体不一致，因为这些常见病原体的检测传统上需要 将患者或患者样本（可能长距离）运送到有限数量的地点 诊断实验室，然后进行微生物学、病毒学和 分子实验室可能需要几天时间才能获得结果。 如果没有适当的治疗，病情可能会恶化。 快速识别病原体。 在护理点引起传染性腹泻病的药物可以挽救生命并改善健康 通过对发展中国家的潜在用户提供及时和适当的治疗来获得结果。 世界可以在农村地区或健康状况不佳的城市低收入人群中建立三级诊所 护理利用和调查疫情的国家公共卫生现场官员的目标。 我们的项目是确定开发一种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缩方法整合步骤 用于多重核酸捕获总核酸的中空二氧化硅微球 我们将测试来自患者的 600 份粪便样本。 参加了一项正在进行的孟加拉国低收入社区胃肠道疾病研究，其中 霍乱、沙门氏菌、志贺氏菌、弯曲杆菌等病原体感染的流行率 高 该项目的成功可以对其他简单、点的开发产生广泛的影响。 在其他样本类型中对引起其他疾病的病原体进行非护理差异检测测试。