Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
基本信息
- 批准号:10084274
- 负责人:
- 金额:$ 30万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-01-10 至 2022-12-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdultAffectAnthelminticsAntigensAntiparasitic AgentsBiological AssayBlood donorBlood specimenBrainBrain DiseasesCenters for Disease Control and Prevention (U.S.)ChemistryClinicalCollaborationsComplexComputer softwareCystDataDetectionDevelopmentDevicesDiagnosisDiagnosticDiseaseElectroencephalogramElectroencephalographyEngineeringEnsureEnzymesEpilepsyEtiologyEuropeFamily suidaeFrequenciesGoalsGoldHumanHygieneImageImmigrationImmunoassayIncomeIndividualInfectionInfrastructureLabelLaboratoriesLateralLocationMagnetic Resonance ImagingMeasurementMedicalMembraneMethodsNeurocysticercosisParasitic DiseasesParasitic infectionPatientsPerformancePhasePreparationPriceProceduresPublishingReaderReagentRecombinantsReproducibilityResistanceRunningSamplingSeizuresSensitivity and SpecificitySerology testSerumSpecificityStructural defectSynthetic AntigensTaenia soliumTemperatureTest ResultTestingTissuesTrainingTravelVariantWhole BloodWireless TechnologyWorld Health Organizationantibody detectionbaseclinical Diagnosiscostdesigndetection sensitivityeffective therapyfollow-upimaging studyinfection ratelateral flow assaymedical specialtiesnervous system disordernervous system infectionnovelperformance testspoint of carepoint of care testingprototyperelating to nervous systemresearch clinical testingscale upstatisticstoolvalidation studies
项目摘要
Project Summary
Epilepsy, a disorder of the brain manifested by seizures, is the fourth most prevalent neurological disease,
affecting over 50 million people worldwide, or about 1 out of 150 individuals on average. The frequency of
epilepsy is distributed unevenly, however, with the vast majority of cases occurring in less developed regions
of the world. The explanation for this distribution is most likely that one third of all epilepsy cases are due to
Neurocysticercosis, known to be the most common parasitic infection of the nervous system.
Neurocysticercosis is caused by the presence of larval cysts of Taenia solium, the pork tapeworm, in the brain,
which can cause seizures and illness ranging from mild to fatal depending on their location, number and
viability. In contrast to idiopathic epilepsy, a complex disease which can be difficult to treat and resistant to
cure, Neurocysticercosis can be treated and in many cases cured with inexpensive and available anti-
helminthic drugs. Distinguishing whether the cause of seizures is idiopathic epilepsy or Neurocysticercosis is
thus a critical part of the diagnostic workup and essential to determine the appropriate course of treatment for
patients. The established procedures for diagnosing epilepsy comprise electroencephalography and imaging
via MRI, but these sophisiticated tools are of limited availability in the less developed world where
Neurocysticercosis is most frequent. On the other hand, Neurocysticercosis can be diagnosed with a
serological test that detects antibodies to T. solium cysts. The gold standard serological test, the Enzyme
Immunotransfer Blot (EITB) developed at CDC, is a laboratory-based test, however, that is not widely available
and requires significant training to carry out. Thus there is a critical need for a rapid, commercially available
point-of-care test for Neurocysticercosis that can be used to test patients with seizures, in order to identify
those with the parasitic infection so that they can be treated effectively. Development of such a test has been
identified as an urgent priority by the World Health Organization.
In the Phase I project, we will utilize recombinant and synthetic T. solium antigens corresponding to those used
in the EITB to develop a point-of-care serological test for Neurocysticercosis that will meet the criteria in the
World Health Organization’s Target Product Profile. These antigens have shown high sensitivity and specificity
in prior studies, and will be combined to further increase sensitivity for detection of single viable cysts, the most
challenging case. The point-of-care Neurocysticercosis test will be evaluated for sensitivity on a well-
characterized panel of sera from Neurocysticercosis patients confirmed by EITB or clinical diagnosis, and for
specificity on healthy controls and other disease state sera. Test results will be read using a field-friendly,
ultraportable, low-cost reader that will provide objective interpretation and enable wireless upload of data to
local devices or remote servers. Phase II will support complete development to commercial stage, clinical
evaluation and preparation for CE mark and FDA submission of the Neurocysticercosis point-of-care test.
项目摘要
癫痫是一种以癫痫为表现的大脑紊乱,是第四大最常见的神经疾病,
影响到全球超过5000万人,平均每150人中就有1人受到影响。的频率
然而,癫痫的分布并不均匀,绝大多数病例发生在欠发达地区。
这个世界。对这种分布的解释很可能是三分之一的癫痫病例是由于
脑囊虫病,已知是神经系统最常见的寄生虫感染。
脑囊虫病是由猪带绦虫幼虫在大脑中的存在而引起的。
可导致癫痫发作和疾病,从轻微到致命不等,具体取决于它们的位置、数量和
生存能力。与特发性癫痫不同,特发性癫痫是一种复杂的疾病,很难治疗,也很难抵抗
治愈,脑囊虫病是可以治疗的,在许多情况下可以用廉价的可用的抗囊虫药物治愈
蠕虫类药物。区分癫痫发作的原因是特发性癫痫还是脑囊虫病
因此,这是诊断检查的关键部分,对于确定适当的治疗疗程是必不可少的
病人。诊断癫痫的既定程序包括脑电和成像。
但这些诡辩的工具在欠发达世界的可获得性有限
脑囊虫病是最常见的。另一方面,脑囊虫病可以被诊断为
检测弓形虫包囊抗体的血清学试验。黄金标准的血清学检测,酶
CDC开发的免疫转移印迹(EITB)是一种以实验室为基础的检测方法,但并未广泛应用
而且需要大量的培训才能进行。因此,迫切需要一种快速的、商业上可用的
脑囊虫病的看护点测试,可用于测试癫痫患者,以确定
那些有寄生虫感染的人,这样他们才能得到有效的治疗。这样的测试已经开发出来了
被世界卫生组织确定为紧急优先事项。
在第一阶段项目中,我们将利用重组和合成的沙门氏菌抗原
在EITB开发一种针对脑囊虫病的护理点血清学测试,该测试将满足
世界卫生组织的目标产品简介。这些抗原表现出高度的敏感性和特异性。
在先前的研究中,将结合使用,以进一步提高对单个可存活包囊的检测灵敏度,最
具有挑战性的案子。医疗点脑囊虫病测试将在井上进行敏感性评估-
经EITB或临床诊断证实的脑囊虫病患者的特征性血清样本,并用于
对健康对照和其他疾病状态血清的特异性。测试结果将使用现场友好型、
超便携、低成本阅读器,将提供客观解释,并支持将数据无线上传到
本地设备或远程服务器。第二阶段将支持完全开发到商业阶段,临床
CE标志和FDA提交的脑囊虫病护理点检测的评估和准备。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Andrew E. Levin其他文献
Evaluation of a sequential enzyme immunoassay testing algorithm for Lyme disease demonstrates lack of test independence but high diagnostic specificity.
对莱姆病序贯酶免疫分析测试算法的评估表明缺乏测试独立性,但诊断特异性较高。
- DOI:
- 发表时间:
2018 - 期刊:
- 影响因子:2.9
- 作者:
G. Wormser;Claudia R. Molins;Andrew E. Levin;Susan C. Lipsett;L. Nigrovic;M. Schriefer;J. Branda - 通讯作者:
J. Branda
The Babesia observational antibody (BAOBAB) study: A cross-sectional evaluation of Babesia in two communities in Kilosa district, Tanzania
巴贝虫观察性抗体 (BAOBAB) 研究:坦桑尼亚基洛萨区两个社区巴贝虫横断面评估
- DOI:
10.1371/journal.pntd.0007632 - 发表时间:
2019 - 期刊:
- 影响因子:3.8
- 作者:
E. Bloch;Z. Mrango;M. Kasubi;Jerusha Weaver;Aleksandra Mihailovic;B. Munoz;A. Weimer;Andrew E. Levin;L. Tonnetti;J. Linnen;V. Brès;D. Norris;G. Carpi;S. West - 通讯作者:
S. West
Frequency and magnitude of seroreactivity to <em>Babesia microti</em> in 245 patients diagnosed by PCR in New York State
- DOI:
10.1016/j.diagmicrobio.2020.115008 - 发表时间:
2020-05-01 - 期刊:
- 影响因子:
- 作者:
Susan Madison-Antenucci;Gary P. Wormser;Andrew E. Levin;Susan J. Wong - 通讯作者:
Susan J. Wong
Andrew E. Levin的其他文献
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{{ truncateString('Andrew E. Levin', 18)}}的其他基金
Point-of-care diagnostic test for T. cruzi (Chagas) infection
克氏锥虫(恰加斯)感染的即时诊断测试
- 批准号:
10603665 - 财政年份:2023
- 资助金额:
$ 30万 - 项目类别:
Development of an ELISA for serosurveillance of human hookworm
开发用于人类钩虫血清监测的 ELISA
- 批准号:
10697222 - 财政年份:2023
- 资助金额:
$ 30万 - 项目类别:
Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
- 批准号:
9909230 - 财政年份:2020
- 资助金额:
$ 30万 - 项目类别:
Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
- 批准号:
10699435 - 财政年份:2020
- 资助金额:
$ 30万 - 项目类别:
Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
混合 ELISA:针对莱姆病的简单而特异的一层检测
- 批准号:
9886194 - 财政年份:2019
- 资助金额:
$ 30万 - 项目类别:
Biomarker-Based Test of Cure for Chagas Disease
基于生物标记的恰加斯病治愈测试
- 批准号:
10761244 - 财政年份:2019
- 资助金额:
$ 30万 - 项目类别:
Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
混合 ELISA:针对莱姆病的简单而特异的一层检测
- 批准号:
10758919 - 财政年份:2019
- 资助金额:
$ 30万 - 项目类别:
Point-of-care diagnostic test for T. cruzi (Chagas) infection
克氏锥虫(恰加斯)感染的即时诊断测试
- 批准号:
9757680 - 财政年份:2018
- 资助金额:
$ 30万 - 项目类别:
Serologic assays for detection of Zika virus antibodies for clinical diagnosis and blood donor counseling
用于检测寨卡病毒抗体的血清学检测,用于临床诊断和献血者咨询
- 批准号:
10221519 - 财政年份:2017
- 资助金额:
$ 30万 - 项目类别:
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