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数据，每年有17亿例胃肠炎病例 去年，约有150万名儿童死亡。腹泻病是第二大疾病 五岁以下儿童死亡的原因，主要是在发展中国家。范围很广 细菌、病毒和寄生性病原体可导致疾病，合并感染是常见的 在疾病负担高的低收入国家。临床确定的治疗资源-- 有限的医疗保健设置经常在没有病因学知识的情况下进行。结果, 抗生素处方过多，针对性不强，由病原体引起的感染 高死亡率可能得不到足够高质量的护理。对这些进行诊断测试 病原体是不一致的，因为这些常见病原体的检测传统上需要 将病人或病人样本，可能远距离运送到有限数量的 诊断实验室，然后在微生物学、病毒学和 分子实验室。结果可能在几天内无法得到，在此期间，患者的 如果没有适当的治疗，病情可能会恶化。病原体的快速鉴定 在护理地点引起传染性腹泻的疾病可能会挽救生命和改善健康 通过提供及时和适当的治疗来解决这一问题。开发中的潜在用户 世界上可能包括农村地区的三级诊所或健康状况较差的城市低收入人群 保健利用情况和调查疫情的国家公共卫生实地工作人员。的目标是 我们的项目是确定开发一种创新的纸条测试的可行性，该测试可以 集成了低成本、简单的粪便样品制备和浓缩法的步骤 复合核酸捕获总核酸的中空二氧化硅微球 在纸条装置上进行放大和检测。我们将检测600个病人的粪便样本 参加了孟加拉国低收入社区正在进行的胃肠道疾病研究 霍乱、沙门氏菌、志贺氏菌、弯曲杆菌等病原体感染的流行率为 很高。这个项目的成功可以对开发其他简单的、点- 在其他样本类型中对引起其他疾病的病原体进行护理差异检测试验。