Rapid, Point of Care Diagnostic for Malaria, highly sensitive for P. vivax, with species differentiation

疟疾快速护理点诊断，对间日疟原虫高度敏感，具有物种分化

• 批准号: 10231237
• 负责人: PETER GALEN
• 金额: $ 82.78万
• 依托单位: HEMEX HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-06 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10231237
• 关键词: Affect; Algorithms; Birefringence; Blood; Cessation of life; Clinical; Clinical Data; Clinical Research; Contracts; Detection; Devices; Diagnosis; Diagnostic; Diffuse; Disease; Disease Progression; Electronics; Funding; Goals; Hemoglobin; Human; Incidence; Infection; Iron; Liver; Malaria; Metastatic Neoplasm to the Liver; Microscopy; Noise; Optics; Outcome; Parasites; Patients; Pharmaceutical Preparations; Phase; Plasmodium falciparum; Plasmodium vivax; Plastics; Prevalence; Published Comment; Reaction; Reader; Recurrent disease; Regimen; Running; Sensitivity and Specificity; Shapes; Signal Transduction; Small Business Innovation Research Grant; System; Technology; Testing; Time; Treatment Protocols; United States National Institutes of Health; Validation; Virulent; Work; detection limit; diagnostic platform; hemozoin; improved; magnetic field; malaria infection; malaria transmission; point of care; point-of-care diagnostics; portability; signal processing; time use

Project Summary/Abstract While significant progress has been made in reducing malaria prevalence and deaths, malaria elimination remains an extremely difficult goal. P. falciparum and P. vivax species of malaria parasites account for ~95% of all human malaria infections. P. falciparum is more virulent and has a higher incidence of adverse clinical outcomes, but P. vivax is more pervasive and widespread, often becoming the predominant species in regions moving toward elimination. These parasites follow a different course of disease and the treatment regimen differs, requiring an additional drug for P. vivax to eliminate a liver stage which causes disease relapse potentially years after infection. Current diagnostics have suboptimal accuracy, especially for P. vivax, as well as delayed turnaround times. Hemex aims to develop a one-minute, $1, point-of-care diagnostic that has a limit of detection for P. vivax >5x lower than RDTs. This diagnostic platform will also have the ability to differentiate between P. falciparum and P. vivax to allow for appropriate treatment. The proposed project advances our current rapid malaria detection device, which detects the presence of any malaria parasites in patients with >95% accuracy compared to microscopy. The new capability will be commercialized into a robust, portable, point-of-care product. It has the potential to greatly reduce malaria transmission and could substantially contribute towards reduction in human suffering as well as help to achieve malaria elimination.

项目摘要/摘要 虽然在减少疟疾流行和死亡方面取得了重大进展，但疟疾 消除艾滋病仍然是一个极其困难的目标。恶性疟原虫和间日疟原虫 寄生虫占所有人类疟疾感染的95%。恶性疟原虫的毒力更强， 有较高的不良临床结局发生率，但间日疟原虫更普遍， 分布广泛，经常成为濒临灭绝的地区的优势物种。 这些寄生虫遵循不同的病程，治疗方案也不同，需要 一种用于间日疟原虫的额外药物，用于消除可能导致疾病复发的肝期 感染数年后。 目前的诊断准确率不是最好的，特别是对间日疟原虫，以及延迟的 周转时间。Hemex的目标是开发一种一分钟、1美元的医疗诊断程序，它具有 对间日疟原虫的检出限比RDTs低5倍。该诊断平台还将具有 能够区分恶性疟原虫和间日疟原虫，以便进行适当的治疗。这个 拟议的项目改进了我们目前的快速疟疾检测设备，该设备可以检测是否存在 在所有疟疾寄生虫患者中，与显微镜相比，准确率为95%。新的 这一能力将被商业化，成为一种坚固、便携的护理点产品。它有潜力 大大减少疟疾的传播，并可大大有助于减少 这不仅有助于消除疟疾，也有助于人类的痛苦。