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.
项目总结
强大、高效和可靠的SARS-CoV-2检测是非常具有挑战性的,因为我们缺乏超
对病毒的敏感化验和不断发展的知识。标准的基于聚合酶链式反应的检测结果仍然很高
感染初期的假阴性率。临床样品的微流控处理成本低,
显示了将大多数液体活组织检查转化为临床的巨大希望。我们的实验室是第一批
应用微流控技术分离血液中循环肿瘤细胞和外周血中的外切体
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来源
用于病毒检测以及其他可能告知我们感染情况的临床生物标志物。因此,对于这架U18,
我们将优化我们的外体捕获技术,EVHB芯片,用于分离完整的SARS-CoV-2病毒,
测试其对每一种生物体液的效用。为了完成这项工作,我们将完成全面的临床验证和
对化验结果进行基准测试。一旦完全优化,我们的检测分析将与现有的EUA进行比较
用SARS-CoV-2检测方法确定检测的敏感性和特异性。此外,我们计划演示
我们的微流控设备带来的更高的灵敏度和特异度将导致更早地检测到
SARS-CoV-2,减少了这一检测窗口的假阴性。在这项工作完成后,我们将拥有
收集数据训练集并提交完整的EUA计划,使FDA能够授权我们的
将在临床上使用的测试。
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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