Rapid LFIA blood test for SCD using highly specific monoclonal antibodies
使用高度特异性单克隆抗体对 SCD 进行快速 LFIA 血液检测
基本信息
- 批准号:9170967
- 负责人:
- 金额:$ 50万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-08-01 至 2018-07-31
- 项目状态:已结题
- 来源:
- 关键词:AdultAffectAmino AcidsAreaAwarenessBedside TestingsBiological AssayBloodBlood TestsBlood VolumeBlood specimenBrazilClinicalClinical ResearchCollaborationsCommunitiesConsultationsDataDetectionDeveloping CountriesDevelopmentDiagnosisDiagnostic testsDiseaseEarly InterventionEarly treatmentEnvironmentHeadHealthcareHematologyHemoglobinHigh PrevalenceHome environmentImmunoassayIndividualInterventionLaboratoriesLateralLifeMarketingMedicalMethodsMonoclonal AntibodiesMorbidity - disease rateMutationNeonatal ScreeningPatient-Focused OutcomesPerformancePhasePhenotypePopulationPostdoctoral FellowPregnancy TestsPreparationPriceProceduresProductionReportingResearch DesignResearch PersonnelResourcesSamplingSickle Cell AnemiaSpottingsTechnologyTemperatureTest ResultTestingTimeTranslational ResearchUniversitiesValidationVariantWhole BloodWorkbasecarrier statuscostdesigndisease phenotypeeffective therapyexperiencehemoglobin AAimprovedinstrumentmid-career facultymortalitypediatric departmentpoint-of-care diagnosticspre-clinicalpreventprofessorprogramsprototypescreeningsocialtraittreatment centertrial designvalidation studies
项目摘要
PROJECT SUMMARY/ABSTRACT
This proposal describes Phase II of the development of a rapid immunoassay test kit for
the determination of hemoglobin variants in blood, to be used as a point-of-care
diagnostic test for sickle cell disease (SCD) and SCD carrier trait in low-resource
settings worldwide. Today, determination of SCD and SCD trait requires lengthy and
expensive laboratory analyses that are not available in low-resource settings, and >80%
of individuals with SCD and SCD trait live in areas where healthcare is provided in those
settings. Nevertheless, newborn screening programs have resulted in significant
improvement of patient outcomes due to early treatment to prevent complications of the
disease.
The proposed test kit will be a lateral flow immunoassay, similar in principle to a home
pregnancy test. The test design is based on monoclonal antibodies (MAbs) specific for
the single-amino-acid differences between SCD-related hemoglobin variants. In Phase I,
the applicant developed a working prototype hemotyping test kit which was shown to
correctly identify the phenotype of >99% of tested whole blood samples, including each
relevant SCD and carrier phenotype. The prototype test requires a 1-microliter volume of
blood and the time-to-result is under 20 minutes. In Phase II, the test kit will be further
improved and simplified, and a complete manufacturable product will be developed.
Clinical validation studies will be carried out to determine the real-world performance of
the product, including studies performed in low-resource settings in Brazil. At the
successful conclusion of Phase II, the test kit will be ready for manufacturing and
submission for approval to regulatory agencies worldwide. The estimated cost of the
hemotyping test kit will be $2.00, a price point that will allow widespread acceptance of
this test kit in developing countries.
项目总结/文摘
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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MARK GEISBERG其他文献
MARK GEISBERG的其他文献
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使用高度特异性单克隆抗体对 SCD 进行快速 LFIA 血液检测
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Rapid LFIA blood test for SCD using highly specific monoclonal antibodies
使用高度特异性单克隆抗体对 SCD 进行快速 LFIA 血液检测
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