Rapid quantitation of residual WBCs in filtered blood

快速定量过滤后血液中残留的白细胞

• 批准号: 6739404
• 负责人: John D Roback
• 金额: $ 9.95万
• 依托单位: TRANSFUSION AND TRANSPLANTATION TECH
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-01 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6739404
• 关键词: biomedical automation; biotechnology; blood filtration; clinical research; computer program /software; computer system design /evaluation; cost effectiveness; flow cytometry; high throughput technology; human tissue; immunohematology; leukocytes; reagent /indicator; technology /technique development

DESCRIPTION (provided by applicant): This revised Phase I STTR application is focused on providing proof-of-concept for a novel, high throughput, completely automated assay for routine quality control (QC) monitoring of residual leukocytes (rWBCs) in filtered blood prior to transfusion. As the use of filter leukoreduction increases, and accumulating data suggests that filter failures can lead to morbidity in transfusion recipients, the FDA may implement more rigorous QC guidelines to confirm that rWBCs have been reduced to below acceptable levels (5 x 10(6)) in filtered blood components. Should QC requirements increase significantly, manual Nageotte hemocytometry will no longer be a feasible method for counting rWBCs. While flow cytometry represents an alternative approach, standard cytometers are expensive (>$100,000), particularly since they must be operated manually. 3Ti is fabricating a completely automated immunohematology-testing platform that incorporates an inexpensive, small-footprint flow cytometer (funded through previous STTR grants). The objective of the proposed studies is to develop an accurate, cost-effective, high-throughput rWBC assay for this workstation. In Specific Aim #1, we will optimize the staining reagents for accurate quantitation of rWBCs with this flow cytometer. In Specific Aim #2, we will integrate the rWBC counting assay onto the automated workstation. If the proposed studies result in an automated rWBC counting assay that demonstrates sufficient accuracy, throughput, and cost-effectiveness, Phase II funding will be sought to conduct multicenter clinical trials with the objectives of further validating and commercializing this system. Successful completion of this work will lead to the first completely automated workstation for rWBC counting, and further demonstrate the utility of this multifunctional platform for walk-away automated testing in blood centers and transfusion services.

描述（由申请人提供）：此修订后的I期STTR应用程序侧重于为常规质量控制（QC）监测残留白细胞（RWBC）在输血前的过滤血液中监测常规质量控制（RWBC）的新颖，高通量，完全自动化的测定法。随着使用过滤器白细胞的使用增加，累积数据表明过滤器失败可能导致输血受体的发病率，FDA可能实施了更严格的QC指南，以确认RWBC已将RWBC降低至低于可接受的水平（5 x 10（6））过滤血液成分的水平（5 x 10（6））。如果QC要求大大增加，手动纳戈特血细胞仪将不再是计数RWBC的可行方法。尽管流式细胞仪代表另一种方法，但标准的细胞仪很昂贵（> 100,000美元），尤其是因为必须手动操作它们。 3TI正在制造一个完全自动化的免疫血液学测试平台，该平台结合了廉价的小型流式细胞仪（通过以前的STTR赠款资助）。拟议的研究的目的是为此工作站开发准确，成本效益，高通量RWBC测定法。在特定的目标＃1中，我们将优化使用该流式细胞仪准确定量RWBC的染色试剂。在特定的AIM＃2中，我们将将RWBC计数分析集成到自动化工作站上。如果提出的研究导致自动化的RWBC计数测定法证明了足够的准确性，吞吐量和成本效益，则将寻求II期资金来进行多中心临床试验，并具有进一步验证和商业化该系统的目标。这项工作的成功完成将导致第一个完全自动化的RWBC计数工作站，并进一步证明了这个多功能平台在血液中心和输血服务中进行自动测试的实用性。