A Simple at-home test for rapid and accurate screening for Hepatitis C Virus (HCV) exposure
A Simple at-home test for rapid and accurate screening for Hepatitis C Virus (HCV) exposure
批准号:
10709130
负责人:
John Manohar
金额:
$39.38万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-09-20 至 2023-09-19
关键词:
AcuteAntibody ResponseArchivesBiological AssayBlood specimenCharacteristicsChronicChronic Hepatitis CDevelopmentEvaluationExposure toExpression LibraryFDA approvedFingersGenerationsHCV screeningHepatitis CHepatitis C virusHomeHumanImmune responseIndividualLateralMiningMorbidity - disease rateOutputPatientsPerformanceProteomeProteomicsPublic HealthReproducibilitySensitivity and SpecificitySerumSpecimenTechnologyTertiary Protein StructureValidationantibody testassay developmentbaseclinical diagnosiscross reactivitydetection limitexperimental studyhome testimmunogenicindividual responseinnovationlateral flow assaymortalityprototyperapid testscreeningself testingtool
中文摘要
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英文摘要
Development and feasibility demonstration of a prototype rapid and accurate Lateral Flow Assay (LFA) to self-screen qualitatively for exposure to Hepatitis C Virus (HCV) in at-home settings, is proposed. The LFA, employing conserved immunogenic domains of proteins comprising the HCV human immunoproteome, will detect host antibody responses to such immunogenic protein domains in user-generated finger-prick blood samples. Preliminary validation / feasibility will be demonstrated using archived human serum specimens from patients clinically diagnosed to have had acute, chronic, or resolved HCV infection. The highly sensitive and specific assay will be simple enough for self-use, and output results that can be read visually by the end-user within 30 mins. It is anticipated that the resulting LFA will positively impact global public health by accurately identifying exposed individuals for further evaluation and contribute significantly to reducing HCV morbidity and mortality; hence, the LFA will be a valuable addition to the armamentarium of available tools for effective management of individuals with active HCV infection.
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