SAMBA HIV-1 Semi-quantitative whole blood test for resource limited settings
SAMBA HIV-1 Semi-quantitative whole blood test for resource limited settings
批准号:
9142023
负责人:
HELEN H LEE
金额:
$95.15万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-08-03 至 2017-07-31
关键词:
Africa South of the SaharaBedside TestingsBiological AssayBlood TestsBlood specimenCellsDNADataDevelopmentDiagnosticEvaluationHIVHIV-1HousingLaboratoriesLeukocytesMonitorNucleic AcidsPatientsPerformancePhasePlasmaResistanceResistance developmentResourcesSamplingSmall Business Innovation Research GrantTestingTreatment EfficacyTreatment FailureViralViral Load resultVirusWhole Bloodanti-viral efficacyassay developmentbaseclinically relevantfollow-upinstrumentnext generationnon-compliancepoint of careprototypepublic health relevancescale up
中文摘要
英文摘要
DESCRIPTION (provided by applicant): The ultimate aim of this project is to develop diagnostic platform for viral load monitoring using whole blood samples of HIV-1 infected patients in point-of-care (POC) and resource-limited settings to be submitted for WHO prequalification and/or CE-marking. Estimation of viral load in HIV-1 patients receiving anti-viral
treatment (ART) is considered the best marker for monitoring the efficacy ART, identifying and discriminating non-compliance and resistance. Currently all viral load tests are performed from plasma samples since using whole blood gives an overestimation of the viral load due to amplification of integrated HIV DNA in nucleated white blood cells. Diagnostics for the Real World (DRW) has developed the SAMBA HIV-1 Whole Blood Semi-quantitative Test (SAMBA-WBSQ) for use at POC and in resource-limited setting during Phase I. SAMBA-WBSQ uses leukodepletion to remove the nucleated cells and can distinguish between patients with viral loads above or below a predetermined clinically relevant cut-off, of 1,000 copies/ml, to aid clinicians to monitor non- compliance, treatment efficacy or treatment failure due to the development of resistance. This proposal is to further develop and optimize the SAMBA-WBSQ assay for regulatory submission to WHO prequalification and/or CE-marking.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Feasibility and development of an automated HIV self-testing system
-
批准号:10223133
-
项目类别:
-
资助金额:$41.15万
-
财政年份:2019
-
负责人:HELEN H LEE
-
依托单位:
Feasibility and development of an automated HIV self-testing system
-
批准号:10004563
-
项目类别:
-
资助金额:$41.66万
-
财政年份:2019
-
负责人:HELEN H LEE
-
依托单位:
SAMBA HIV-1 Semi-quantitative Test for resource limited settings
-
批准号:8310932
-
项目类别:
-
资助金额:$27.61万
-
财政年份:2011
-
负责人:HELEN H LEE
-
依托单位:
SAMBA HIV-1 Semi-quantitative Test for resource limited settings
-
批准号:8211102
-
项目类别:
-
资助金额:$30.0万
-
财政年份:2011
-
负责人:HELEN H LEE
-
依托单位:
SAMBA HIV-1 Semi-quantitative Test for resource limited settings
-
批准号:8659952
-
项目类别:
-
资助金额:$74.75万
-
财政年份:2011
-
负责人:HELEN H LEE
-
依托单位:
SAMBA HIV-1 Semi-quantitative Test for resource limited settings
-
批准号:8874861
-
项目类别:
-
资助金额:$61.76万
-
财政年份:2011
-
负责人:HELEN H LEE
-
依托单位:
Triplex HBV, HCV an HIV dipstick for blood banks
-
批准号:7474866
-
项目类别:
-
资助金额:$57.57万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
Triplex HIV, HCV and HBV dipstick
-
批准号:6551337
-
项目类别:
-
资助金额:$13.45万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
Triplex HBV, HCV an HIV dipstick for blood banks
-
批准号:7020765
-
项目类别:
-
资助金额:$44.15万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
Triplex HBV, HCV an HIV dipstick for blood banks
-
批准号:6882571
-
项目类别:
-
资助金额:$40.25万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
DRW HIV-Ab/HCV-Ab/HBsAg Triplex Rapid Test Submission for FDA-PMA Approval
-
批准号:7804442
-
项目类别:
-
资助金额:$107.52万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
DRW HIV-Ab/HCV-Ab/HBsAg Triplex Rapid Test Submission for FDA-PMA Approval
-
批准号:8099428
-
项目类别:
-
资助金额:$83.62万
-
财政年份:2003
-
负责人:HELEN H LEE
-
依托单位:
Preclinical and clinical studies of an HBV rapid test for FDA Pre-market approval
-
批准号:7407634
-
项目类别:
-
资助金额:$96.45万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
HIV dipstick for resource-limited blood banks
-
批准号:6891500
-
项目类别:
-
资助金额:$112.95万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
DRW HIV-Ab/HBsAg Duplex Rapid Test submission for FDA-PMA approval
-
批准号:7539876
-
项目类别:
-
资助金额:$176.3万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
HCV dipstick for resource-limited blood banks
-
批准号:7020764
-
项目类别:
-
资助金额:$35.82万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
HCV dipstick for resource-limited blood banks
-
批准号:6882953
-
项目类别:
-
资助金额:$33.06万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
HBV dipstick for resource-limited blood banks
-
批准号:6805008
-
项目类别:
-
资助金额:$38.82万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
DRW HIV-Ab/HBsAg Duplex Rapid Test submission for FDA-PMA approval
-
批准号:7689155
-
项目类别:
-
资助金额:$1.98万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位:
HIV dipstick for resoruce-limited blood banks
-
批准号:6551323
-
项目类别:
-
资助金额:$12.72万
-
财政年份:2002
-
负责人:HELEN H LEE
-
依托单位: