Rapid in-field malaria diagnosis, prognosis and monitoring using a mobile phone

使用手机进行快速现场疟疾诊断、预后和监测

• 批准号: 8995627
• 负责人: Peter B Lillehoj
• 金额: $ 47.49万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-16 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8995627
• 关键词: AIDS/HIV problem; Antibodies; Antigens; Area; Bedside Testings; Biological Assay; Biological Sciences; Biomedical Technology; Biosensing Techniques; Biosensor; Blood specimen; Calibration; Car Phone; Cerebral Malaria; Cessation of life; Child; Clinical; Clinical Data; Coma; Communicable Diseases; Computer software; Consumption; Dengue; Detection; Development; Devices; Diagnosis; Diagnostic tests; Disease; Effectiveness; Elements; Enzyme-Linked Immunosorbent Assay; Epidemiologic Monitoring; Generations; Goals; Gold; HRP-2 protein; Health; Health Personnel; Healthcare; Human; Immunity; Individual; Infection; Malaria; Malawi; Measurement; Measures; Microfluidic Microchips; Microfluidics; Mission; Modification; Monitor; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Outcome; Parasitemia; Patient Triage; Patients; Performance; Plasmodium falciparum; Protocols documentation; Public Health; Reagent; Research; Retinal Diseases; Risk; Rotavirus; Sampling; Scheme; Serum; Specimen; System; Technology; Testing; Time; Translating; Triage; Tuberculosis; Validation; Whole Blood; Wireless Technology; Work; base; chromatin immunoprecipitation; clinical Diagnosis; clinical care; comparative; cost effectiveness; data exchange; follow-up; improved; innovation; instrument; light weight; malaria infection; miniaturize; mortality; novel; outcome forecast; physical science; point of care; prognostic; prototype; trend

 DESCRIPTION: Malaria is one of the most deadly infectious diseases in the world. Immunity to malaria illness is acquired gradually and irregularly in malaria-endemic areas and this creates two significant difficulties in its diagnosis and treatment: 1) Individuals who are infected with malaria may be asymptomatic, and conversely, symptomatic individuals with malaria infections may be ill for reasons unrelated to malaria, and 2) A proportion of individuals who present for clinical care with a mild malaria illness will progress to severe disease. At this point in time, i is not possible to predict which patients are at risk of deteriorating, and this greatly complicates clinical care. Recent studies by the applicants and others have demonstrated the utility of quantitative Plasmodium falciparum histidine-rich protein 2 (PfHRP2) measurements for (a) distinguishing parasitemic comatose children with cerebral malaria (CM) from comatose children with incidental parasitemia and a non-malarial cause of coma, and (b) identifying which children with apparently uncomplicated malaria are likely to progress to a more serious illness. Currently, PfHRP2 quantification requires an enzyme-linked immunosorbent assay (ELISA) test which is expensive, laborious and time-consuming. Malaria rapid diagnostic tests for PfHRP2 are available, but these assays only provide qualitative results ("positive" vs. "negative") and are no useful for the indications above. The long-term goal is to improve the clinical diagnosis of CM and the triage of patients with uncomplicated malaria. The primary objective of this project is to develop and validate a field-ready mobile phone platform for rapid, quantitative PfHRP2 measurements. The rationale for the proposed research is supported by the applicants' preliminary clinical data, and the feasibility of integrating a miniaturized detection scheme onto conventional mobile phone for rapid, quantitative PfHRP2 measurements of human serum and blood samples. An optimized second-generation prototype device will be developed and validated by pursuing three specific aims: 1) Develop a field-ready, mobile phone platform for quantitative PfHRP2 detection; 2) Validate and optimize device functionality; 3) Evaluate device effectiveness for determining CM diagnosis in patients with CM in field settings. This approach is innovative because it integrates microfluidics with a rapid, quantitative electrochemical detection scheme onto a compact mobile phone platform, and it is significant because is it will improve cerebral malaria prognosis and treatment, and thus, help to reduce malaria-related morbidity and mortality.

 描述：疟疾是世界上最致命的传染病之一，在疟疾流行地区，对疟疾疾病的免疫力是逐渐且不规则地获得的，这给其诊断和治疗带来了两个重大困难：1）感染疟疾的个体可能会出现疟疾。是无症状的，相反，有症状的疟疾感染者可能因与疟疾无关的原因而患病，并且 2) 因轻度疟疾而接受临床护理的患者中，有一部分将发展为目前，我无法预测哪些患者有恶化的风险，这使临床护理变得非常复杂，申请人和其他人的最近研究已经证明了定量恶性疟原虫富含组氨酸蛋白2的效用。 (PfHRP2) 测量用于 (a) 区分患有脑型疟疾 (CM) 的寄生虫昏迷儿童与患有偶发寄生虫血症和非疟疾原因昏迷的昏迷儿童，以及 (b)确定哪些患有明显无并发症的疟疾的儿童可能会发展为更严重的疾病。目前，PfHRP2 定量需要酶联免疫吸附测定 (ELISA) 测试，这种测试昂贵、费力且耗时。 ，但这些检测仅提供定性结果（“阳性”与“阴性”），对上述适应症没有用。长期目标是改善 CM 的临床诊断和分诊。该项目的主要目标是开发和验证用于快速、定量 PfHRP2 测量的现场就绪移动电话平台。拟议研究的基本原理得到了申请人的初步临床数据和可行性的支持。将小型化检测方案集成到传统手机上，以对人体血清和血液样本进行快速定量 PfHRP2 测量 将通过追求三个特定目标来开发和验证优化的第二代原型设备：1）开发现场就绪的、用于定量 PfHRP2 检测的手机平台；2) 验证和优化设备功能；3) 评估现场环境下确定 CM 诊断的设备有效性。一个紧凑的移动电话平台，其意义重大，因为它将改善脑型疟疾的预后和治疗，从而有助于降低与疟疾相关的发病率和死亡率。