A Flow Through Cell Counting Assay

流式细胞计数测定

基本信息

批准号：
8701344
负责人：
Simon Bystryak
金额：
$ 46.4万
依托单位：
ALLIED INNOVATIVE SYSTEMS, LLC
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 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8701344
关键词：
Acquired Immunodeficiency Syndrome Address Adult Affect Africa South of the Sahara Anti-Retroviral Agents Belief Biological Assay Blood Blood Glucose Businesses CD4 Lymphocyte Count CD4 Positive T Lymphocytes Caring Cell Count Childhood Clinical Cost Analysis Country Data Reporting Developing Countries Development Devices Disease Management Educational Status Epidemic Equipment Flow Cytometry Goals Gold HIV HIV Infections Hand Human Laboratories Laboratory Technicians Legal patent Leukocytes Licensing Manuals Measurement Measures Membrane Methods Monitor Patients Performance Phase Procedures Process Production Public Health Reading Reagent Reproducibility Research Resources Sampling Sensitivity and Specificity Signal Transduction Small Business Innovation Research Grant Speed Staging Techniques Technology Testing Therapeutic Training Validation Whole Blood World Health Organization antiretroviral therapy assay development base clinical practice clinically significant cost design falls glucose monitor innovation instrument instrumentation meetings miniaturize new technology novel point of care prognostic prototype public health relevance treatment 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）：支撑研究的长期目标是在人类血液中开发或枚举CD4+ T淋巴细胞。 CD4+ T细胞的每血具有关键的预后和治疗性分期和治疗决策。 - 限制国家。此外，他们要求技术人员处理和处理基于众多艾滋病毒的人的CD4细胞，这是世界卫生组织的D4计数分析和易于执行的方法，即不受CD4+ T细胞惯例的限制。通过培训。 - FTCA Ablood葡萄糖仪的ftca信号测量值； FTCA试剂; 4）通过检查拟议技术的优势来验证FTCA。