A Flow Through Cell Counting Assay
流式细胞计数测定
基本信息
- 批准号:8467313
- 负责人:
- 金额:$ 47.8万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2010
- 资助国家:美国
- 起止时间:2010-03-05 至 2015-06-30
- 项目状态:已结题
- 来源:
- 关键词:Acquired Immunodeficiency SyndromeAddressAdultAffectAfrica South of the SaharaAnti-Retroviral AgentsBeliefBiological AssayBloodBlood GlucoseBusinessesCD4 Lymphocyte CountCD4 Positive T LymphocytesCaringCell CountChildhoodClinicalCost AnalysisCountryData ReportingDeveloping CountriesDevelopmentDevicesDisease ManagementEducational StatusEpidemicEquipmentFlow CytometryGoalsGoldHIVHIV InfectionsHandHumanLaboratoriesLaboratory TechniciansLegal patentLeukocytesLicensingManualsMeasurementMeasuresMembraneMethodsMonitorPatientsPerformancePhaseProceduresProcessProductionPublic HealthReadingReagentReproducibilityResearchResourcesSamplingSensitivity and SpecificitySignal TransductionSmall Business Innovation Research GrantSpeedStagingTechniquesTechnologyTestingTherapeuticTrainingValidationWhole BloodWorld Health Organizationantiretroviral therapyassay developmentbaseclinical practiceclinically significantcostdesignfallsglucose monitorinnovationinstrumentinstrumentationmeetingsminiaturizenew technologynovelpoint of careprognosticprototypepublic health relevancetreatment strategy
项目摘要
DESCRIPTION (provided by applicant): The long-term goal of the proposed research is to develop a novel quantitative flow through cell counting method for enumeration of CD4+ T lymphocytes in human blood. CD4 cell counts are needed to stage and monitor HIV-infected patients. In adults, the absolute number of CD4+ T cells per microlitre of blood has critical prognostic and therapeutic implications, and is used for both HIV staging and treatment decisions. The gold standard technique currently used for quantitation of CD4 cells is flow cytometry. However, flow cytometers, including smaller single-purpose CD4 cell counting devices developed recently are expensive and inaccessible in resource-limited countries. In addition, they require trained laboratory technicians to handle and process samples and to analyze and report data. Because flow cytometry-based CD4 cell counting is beyond the reach of so many HIV-infected people, the World Health Organization (WHO) has urged the development of simple point-of-care CD4 cell count assays designed for resource-limited settings. It is in this context that the less expensive, rapid and easy-to-perform method, which is
free from the limitations of the conventional assays, for determination of CD4+ T cells is proposed to be developed. The proposed method, flow-through cell counting assay (FTCA) is based on the use of the special membrane and a proprietary flow-through cassette to measure cell count status. The test can potentially be completed in less than 15 minutes and can be performed by laboratory technicians with low levels of training. The specific aims of Phase II are: 1) To design and assemble a pre-production ¿-prototype of the FTCA cassette and adapt a blood glucose meter for the FTCA signal measurements; 2) To explore all variables affecting the performance of the FTCA CD4+ T-cell counting method and optimize the performance of the assay; 3) To prepare lyophilized immuno-reagents for performing FTCA and examine the stability of all FTCA reagents; 4) To validate the FTCA by examining a statistically significant number of clinical samples. Advantages of the proposed technology such as the speed, convenience, and low cost of the analysis substantiates our belief that the FTCA will be widely used in clinical practice.
描述(由申请人提供):本研究的长期目标是开发一种新型定量流式细胞计数方法,用于计数人血液中的 CD4+ T 淋巴细胞。需要 CD4 细胞计数来对 HIV 感染患者进行分期和监测。在成人中,每微升血液中 CD4+ T 细胞的绝对数量具有重要的预后和治疗意义,可用于 HIV 分期和治疗决策。目前用于 CD4 细胞定量的黄金标准技术是流式细胞术。然而,流式细胞仪,包括最近开发的较小的单一用途 CD4 细胞计数设备,价格昂贵且在资源有限的国家难以获得。此外,他们还需要经过培训的实验室技术人员来处理和处理样品以及分析和报告数据。由于许多 HIV 感染者无法进行基于流式细胞术的 CD4 细胞计数,因此世界卫生组织 (WHO) 敦促开发专为资源有限的环境设计的简单的护理点 CD4 细胞计数测定法。正是在这种背景下,出现了成本较低、快速且易于执行的方法,即
建议开发用于测定 CD4+ T 细胞的方法,以摆脱传统测定法的限制。 所提出的方法,流通细胞计数测定(FTCA)是基于使用特殊的膜和专有的流通盒来测量细胞计数状态。该测试可能会在 15 分钟内完成,并且可由培训水平较低的实验室技术人员执行。第二阶段的具体目标是: 1) 设计和组装 FTCA 盒的预生产 ¿ 原型,并采用血糖仪进行 FTCA 信号测量; 2) 探索影响 FTCA CD4+ T 细胞计数方法性能的所有变量并优化检测性能; 3) 制备用于进行FTCA的冻干免疫试剂,并检查所有FTCA试剂的稳定性; 4) 通过检查具有统计意义的大量临床样本来验证 FTCA。 所提出的技术的优势,例如分析的速度、便利性和低成本,证实了我们的信念,即 FTCA 将广泛应用于临床实践。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
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Simon Bystryak其他文献
Simon Bystryak的其他文献
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