MalariSense: Transdermal Bloodless and Reagent-Free Malaria Diagnostics

MalariSense：透皮无血、无试剂疟疾诊断

• 批准号: 9764243
• 负责人: Umberto D'Alessandro
• 金额: $ 47.88万
• 依托单位: MASIMO CORPORATION
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-17 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9764243
• 关键词: Acoustics; Address; Adopted; Algorithms; Animals; Area; Biological; Blood; Blood Cells; Blood Circulation; Blood Donations; Blood Pressure; Blood Screening; Blood Vessels; Blood capillaries; Blood specimen; Cells; Clinic; Clinical; Clinical Research; Communities; Computer software; Cost Analysis; Country; Crystallization; Culicidae; Data; Detection; Devices; Diagnosis; Diagnostic; Diagnostic tests; Dimensions; Disease; Ear; Erythrocytes; Future; Gambia; Generations; Goals; Health care facility; Human; In Vitro; Individual; International; Laboratories; Lasers; Life; Liquid substance; Malaria; Medical; Methodology; Methods; Microscopy; Monitor; Mus; Needles; Non-Invasive Cancer Detection; Normal Cell; Optics; Parasitemia; Parasites; Patients; Performance; Peripheral; Physiologic pulse; Protocols documentation; Pulse Pressure; Reagent; Reporting; Research; Sensitivity and Specificity; Signal Transduction; Skin; System; Technology; Testing; Time; Translating; Treatment Efficacy; Ultrasonography; Work; animal data; base; cost; detector; field study; hemozoin; human data; improved; in vivo; malaria infection; nanobubble; nanoparticle; nanosecond; nanosized; new technology; nonmedical use; operation; portability; pressure; prototype; public health relevance; response; routine screening; screening; software development; sound; subcutaneous; transmission process; tv watching; vapor; wasting

 DESCRIPTION: Almost a million people are ill from malaria each day while severe malaria disease claims the lives of 600,000 people each year. A rugged, portable sensitive and accurate method to diagnose malaria without blood sampling and using the reagents would be ideal and addresses the critical problem of malaria diagnosis in field or in asymptomatic cases. The MalariSense technology is able to make a diagnosis through the skin within seconds without using reagents or a needle to obtain blood. The device works by shining a short safe laser pulse that penetrates the skin to small blood vessels. The malaria parasite has a crystal inside of itsel that is able to absorb the laser energy to make a small vapor nanobubble that expands and collapses. The collapsing vapor nanobubble generates a pressure wave that is able to be detected by an ultrasound detector. Uninfected red blood cells are not affected by the laser and do not make a vapor bubble. The proof of MalariSense concept was demonstrated in animals and humans by shining a laser on the ear and detecting the sound pings. In this project, the discovered mechanism will be translated into a field, easy-to-use diagnostic device to non- invasively detect both symptomatic and asymptomatic malaria infections in seconds, and to screen > 200,000 people per year with a single device with a diagnosis cost below 0.1$. This will be achieved through several connected activities: (1) Determine the methodology and specifications for the MalariSense technology; (2) Develop and prototype the MalariSense technology for field use; (3) Evaluate the MalariSense technology in endemic area, determine its performance and applications, and develop the platform for a global screening of malaria. The applications for analyzing mosquitoes, blood samples and small animals will also be developed and tested the ability to make the sensitive diagnosis of malaria through the skin opens up a whole new dimension to malaria diagnosis. The impact and applications are many. The ability to diagnose and treat asymptomatic people living in malaria areas will help greatly the strategies to eliminate malaria from regions. Another dimension of the device is the ability to enable the immediate global access and analysis of the raw data for the remote monitoring of malaria infection. The developed software, protocol and device will act as a platform for the future implementation of the global malaria diagnostic system to radically improve the malaria control and elimination in multiple settings. Just 1000 units will annually screen 200 million people to cover all current disease cases.

 描述：每天有近100万人因疟疾而患病，而严重的疟疾疾病每年夺去60万人的生命。一种坚固、便携、灵敏和准确的方法来诊断疟疾，而不需要血液采样和使用试剂，将是理想的，并解决了在实地或在无症状病例中诊断疟疾的关键问题。MalariSense技术能够在几秒钟内通过皮肤进行诊断，而无需使用试剂或针头来获取血液。该装置的工作原理是发出一个短的安全激光脉冲，穿透皮肤到小血管。疟疾寄生虫体内有一个晶体，它能够吸收激光能量，形成一个小的纳米气泡，可以膨胀和收缩。塌陷的蒸汽纳米气泡产生能够被超声检测器检测到的压力波。未受感染的红细胞不受激光的影响，也不会产生气泡。MalariSense概念的证明是通过在动物和人类的耳朵上照射激光并检测声音ping来证明的。在该项目中，所发现的机制将被转化为现场，易于使用的诊断设备，以在几秒钟内非侵入性地检测有症状和无症状的疟疾感染，并且每年用诊断成本低于0.1美元的单个设备筛查> 20万人。这将通过几项相关活动实现：（1）确定疟疾监测技术的方法和规格;（2）开发疟疾监测技术并制作原型供实地使用;（3）评估疟疾监测技术在流行地区的应用，确定其性能和应用，并开发全球疟疾筛查平台。还将开发和测试用于分析蚊子、血液样本和小动物的应用程序，通过皮肤对疟疾进行敏感诊断的能力为疟疾诊断开辟了一个全新的层面。影响和应用是多方面的。诊断和治疗生活在疟疾地区的无症状者的能力将大大有助于在各区域消除疟疾的战略。该设备的另一个方面是能够立即在全球范围内获取和分析原始数据，以远程监测疟疾感染。开发的软件、协议和设备将作为未来实施全球疟疾诊断系统的平台，从根本上改善多种环境下的疟疾控制和消除。仅1000个单位每年就可以筛查2亿人，覆盖所有现有的疾病病例。