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Molecular and Antibody Detection of Zika Virus in Saliva at the Point of Care

护理点唾液中寨卡病毒的分子和抗体检测

基本信息

批准号：
9350279
负责人：
Haim H Bau
金额：
$ 20.13万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-09 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9350279
关键词：
Address Affinity Americas Antibodies Area Biological Assay Blood Body Fluids Brazil Cellular Phone Centers for Disease Control and Prevention (U.S.)Central America Centrifugation Characteristics Clinic Communication Culicidae Custom Data Dengue Virus Dentists Detection Development Devices Diagnostic Diagnostic tests Disease Outbreaks Enzyme-Linked Immunosorbent Assay FDA approved Fetal Development Fetus Flavivirus Infections Gold Health Heating Home environment Hybrids Immunoassay Individual Infection International Label Laboratories Liquid substance Mediating Methods Microcephaly Microfluidic Microchips Microfluidics Modification Molecular Monitor Neurologic Nucleic Acids Oral Panama Patients Pennsylvania Performance Point-of-Care Systems Pregnancy Pregnant Women Reaction Reporting Research Resources Reverse Transcriptase Polymerase Chain Reaction Reverse Transcription Risk Management Safety Saliva Sampling Seasons Serum Signal Transduction South America Specificity Symptoms System Technology Test Result Testing Time Treatment Efficacy Universities Urine Vascular blood supply Viral Viral Antigens Viremia Virus Diseases Visual Work Zika Virus base cost cross reactivity design improved instrument instrumentation laboratory facility molecular diagnostics pandemic disease pathogen point of care point-of-care diagnostics public health emergency seroconversion therapy development tool vaccine development vaccine efficacy viral detection

项目摘要

ABSTRACT Zika virus (ZIKV) infection with its devastating impact on neurological development of fetuses is already a major health problem in South and Central America, and is likely to impact parts of the USA. Reliable diagnostic tools for ZIKV are vital since ZIKV-infected individuals display either no symptoms or nonspecific symptoms similar to other, more common, viral infections. These diagnostic tools are also essential for management of risks during pregnancy; assessing efficacy of vaccines and therapies; tracking the spread of the infection, tracking ZIKV effects on fetal development; assisting in eradication efforts; and assuring the safety of blood supply. Currently, according to the CDC, no reliable diagnostic tools for ZIKV are available and pipeline technologies are mostly focused on methods suitable for centralized laboratories and inappropriate for resource poor settings and the point of care. This collaborative effort between the University of Pennsylvania and the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) in Panama will research and develop a hybrid, inexpensive, point of care system for combined molecular detection of ZIKV and of antibodies against the ZIKV in oral samples. The proposed system can be used in the clinic, doctor and dentist office, and at home with minimal instrumentation and (optionally) without electrical power. To reduce cost, enable quantification, the system utilizes a smartphone for signal detection, processing, and communications. The system, in its proposed form, is suitable for individual diagnostics, but is amenable to concurrent processing of large numbers of samples. The Penn team will develop the assays: reverse transcription isothermal enzymatic amplification (RT-LAMP) of viral nucleic acids with visual detection of amplicons and an immunoassay to monitor separately antibodies interactions with ZIKV and dengue virus (DENV) antigens to improve assay specificity; and the necessary hardware. ICGES will verify system's performance and ease of use with samples of ZIKV patients in Panama.

摘要寨卡病毒(ZIKV)感染对胎儿神经发育的破坏性影响已经是一种南美洲和中美洲的主要健康问题，并可能影响到美国的部分地区。可靠 ZIKV的诊断工具至关重要，因为ZIKV感染者要么没有症状，要么没有特异性症状类似于其他更常见的病毒感染。这些诊断工具也是必不可少的孕期风险管理；评估疫苗和疗法的有效性；跟踪病毒传播感染，追踪寨卡病毒对胎儿发育的影响；协助根除努力；并确保血液供应安全。目前，根据疾控中心的说法，没有可靠的ZIKV诊断工具可用，管道技术主要集中在适用于集中式实验室的方法，而不适用于资源贫乏的环境和关注点。宾夕法尼亚大学的这项合作努力和巴拿马的研究开发研究所(ICGES)将研究和开发一种廉价的混合护理点系统，用于寨卡病毒和猪瘟的联合分子检测口腔样本中的寨卡病毒抗体。该系统可应用于临床、医生和医疗机构牙医办公室，在家里使用最少的仪器，并且(可选)没有电力。减少成本，实现量化，该系统利用智能手机进行信号检测、处理和通讯。该系统，在其建议的形式，适用于个人诊断，但服从并发处理大量样本。宾夕法尼亚大学的研究小组将开发这种分析方法：反转目视检测病毒核酸转录等温酶扩增(RT-LAMP) 用扩增和免疫测定法分别监测抗体与寨卡病毒和登革病毒的相互作用 (DENV)抗原，以提高检测的特异性；以及必要的硬件。ICGES将验证系统的巴拿马ZIKV患者样本的性能和易用性。