Microfluidic Isolation and Characterization of SARS-CoV-2 and Virus Related Exosomes
SARS-CoV-2 和病毒相关外泌体的微流体分离和表征
基本信息
- 批准号:10321009
- 负责人:
- 金额:$ 99.91万
- 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:2020-12-21 至 2023-11-30
- 项目状态:已结题
- 来源:
- 关键词:2019-nCoVAddressAreaArtsAuthorization documentationBenchmarkingBiologicalBiological AssayBloodBlood PreservationBlood specimenCLIA certifiedCOVID-19COVID-19 detectionCOVID-19 diagnosisCOVID-19 diagnosticCOVID-19 early detectionCOVID-19 patientCOVID-19 point of careCOVID-19 testingCancer CenterCancer PatientCellsClinicClinicalCommunitiesComplexConvalescenceDataDevicesDiagnosisDiagnosticEventFecesFeedbackGoalsImmuneImmunologyInfectionKnowledgeLaboratoriesLeadLiquid substanceMalignant NeoplasmsMicrofluidic MicrochipsMicrofluidicsNeoplasm Circulating CellsOrganOutcomePathway interactionsPatient CarePatientsPhasePlasmaPopulationProductionPublishingRADx RadicalRNARadiologic HealthResolutionResourcesRunningSARS-CoV-2 infectionSalivaSamplingSensitivity and SpecificitySpecialistSpecimenSpecimen HandlingTechnologyTestingTimeTrainingTranslatingValidationVesicleViralVirionVirusWhole BloodWorkacute infectionassay developmentbasecancer cellclinical biomarkerscoronavirus diseasecostcross reactivitydetection assaydetection limitdetection sensitivitydisease phenotypeexosomein-vitro diagnosticsinnovationliquid biopsymicrofluidic technologymolecular diagnosticsnanoscalenew technologynovelnovel strategiesparticlepreservationresearch clinical testingtechnology developmentviral detection
项目摘要
PROJECT SUMMARY
Robust, efficient and reliable testing for SARS-CoV-2 is extraordinarily challenging due to our lack of ultra-
sensitive assays and ever evolving knowledge of the virus. Standard PCR based assays still result in very high
false negative rates in the earliest days of infection. Microfluidic processing of clinical samples is low cost and
shows great promise for translating most liquid biopsy assay to the clinic. Our laboratory was one of the first to
apply microfluidic technologies for the isolation of both circulating tumor cells and exosomes in the blood of
patients with cancer. For SARS-CoV-2 patients, saliva, stool, and plasma are all thought to be potential resources
for both virus detection as well as other clinical biomarkers that might inform us of infection. Thus, for this U18,
we will optimize our exosome capture technology, the EVHB-Chip, for the isolation of intact SARS-CoV-2 virus,
testing its utility for each of these biofluids. To complete this work, we will complete a full clinical validation and
benchmarking of the assay. Once fully optimized, our detection assay will be compared against existing EUA
SARS-CoV-2 detection assay to determine detection sensitivity and specificity. Further, we plan to demonstrate
that the increased sensitivity and specificity enabled by our microfluidic device will result in earlier detection of
SARS-CoV-2, reducing false negatives in this testing window. At the completion of this work, we will have
collected the data training sets and submitted a full EUA plan that would enable the FDA’s authorization of our
test to be used in the clinic.
项目摘要
由于我们缺乏超常规的技术,对SARS-CoV-2进行稳健、高效和可靠的检测是非常具有挑战性的。
灵敏的检测和不断发展的病毒知识。基于标准PCR的测定仍然导致非常高的
感染初期的假阴性率临床样品的微流体处理成本低,
显示出将大多数液体活检测定转化为临床的巨大前景。我们的实验室是最早
应用微流体技术分离血液中的循环肿瘤细胞和外来体,
癌症患者。对于SARS-CoV-2患者来说,唾液、粪便和血浆都被认为是潜在的资源
用于病毒检测以及其他可能告知我们感染的临床生物标志物。因此,对于U18,
我们将优化我们的外泌体捕获技术,EVHB芯片,用于分离完整的SARS-CoV-2病毒,
测试它对每种生物液体的效用为了完成这项工作,我们将完成完整的临床验证,
测定的基准。一旦完全优化,我们的检测方法将与现有的EUA进行比较
SARS-CoV-2检测试验,以确定检测灵敏度和特异性。此外,我们计划展示
我们的微流控装置提高了灵敏度和特异性,
SARS-CoV-2,减少该测试窗口中的假阴性。在这项工作完成后,我们将有
收集了数据训练集,并提交了一份完整的EUA计划,该计划将使FDA能够授权我们的
测试将用于临床。
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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Genevieve Marie Boland其他文献
Socioeconomic and clinical factors associated with delayed initiation of adjuvant chemotherapy for stage III colon cancer.
与延迟开始 III 期结肠癌辅助化疗相关的社会经济和临床因素。
- DOI:
- 发表时间:
2012 - 期刊:
- 影响因子:45.3
- 作者:
Alex Bernard Haynes;Y. Chiang;Genevieve Marie Boland;Y. Xing;N. Massarweh;G. Chang;Y. N. You;B. Feig;J. Cormier - 通讯作者:
J. Cormier
ASO Author Reflections: Adjuvant Treatment of Melanoma in the Modern Era
- DOI:
10.1245/s10434-020-08671-8 - 发表时间:
2020-05-28 - 期刊:
- 影响因子:3.500
- 作者:
Daan Jan Willem Rauwerdink;Genevieve Marie Boland - 通讯作者:
Genevieve Marie Boland
Genevieve Marie Boland的其他文献
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{{ truncateString('Genevieve Marie Boland', 18)}}的其他基金
Microfluidic Isolation and Characterization of SARS-CoV-2 and Virus Related Exosomes
SARS-CoV-2 和病毒相关外泌体的微流体分离和表征
- 批准号:
10266342 - 财政年份:2020
- 资助金额:
$ 99.91万 - 项目类别:
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