Simultaneous Assay for Multiple Pathogens in Blood (SAMP-B)

血液中多种病原体的同时检测 (SAMP-B)

• 批准号: 8315698
• 负责人: Gao Chen
• 金额: $ 49.79万
• 依托单位: MAXWELL SENSORS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-03 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8315698
• 关键词: Antibodies; Automation; Bar Codes; Biological Assay; Blood; Blood Banks; Blood Screening; Blood Tests; Blood donor; Blood donor screening; Blood-Borne Pathogens; Chemistry; Clinical; Computer software; Coupled; Detection; Development; Diagnostic; Disease; Donor Selection; Drops; Evaluation; Fluorescence; Genes; Genetic Materials; Goals; HIV; HIV-1; Hepatitis B; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; Hour; Human; Human Resources; Human T-lymphotropic virus 1; Individual; Infection; Infectious Agent; Label; Laboratories; Lead; Magnetic Bead Technology; Magnetism; Methodology; Methods; Molecular; Molecular Profiling; Nucleic Acid Amplification Tests; Nucleic Acids; One-Step dentin bonding system; Performance; Phase; Phycoerythrin; Procedures; Process; Reaction; Reproducibility; Research; Research Project Grants; Resources; Running; Sampling; Screening procedure; Semiconductors; Sensitivity and Specificity; Specificity; Specimen; Streptavidin; Syphilis; System; Technology; Testing; Time; Training; United States; Variant; Virus; West Nile virus; analog; base; cost; design; digital; flexibility; helicase; instrument; magnetic beads; operation; optical imaging; pathogen; prevent; product development; prototype; sensor; verification and validation

ABSTRACT Rapid, high-throughput, and highly accurate identification of potential blood borne diseases will help blood banks to quickly test a very large volume of donated blood, and will help to prevent further infections. Current blood testing has the following issues: 1. Time consuming testing and sample operation that must be performed for all diseases "one-by-one". 2. A large sample volume is required that depends on the number of tests. 3. Testing procedure is complicated as the number of tests increase. 4. Complicated operational procedures that must be run by highly trained personnel in molecular laboratories. The recent development of commercially-available assays using nucleic acid amplification test technologies (NAT) have made it possible for blood centers to consider applying these tests to blood donor screening. But NAT test systems, so far, are time intensive, not in "multiplexed (> 2) fashion", thus are unsuited to large-scale screening of donor samples for various pathogens. Maxwell Sensors, Inc. (MSI) proposes to combine Helicase-Dependent Amplification and Barcode Magnetic Bead (BMB) technologies to produce a rapid, Simultaneous Assay for Multiple Pathogens in Blood (SAMP-B). With a few drops of a donor's blood combined with digital magnetic beads in a single microwell, it is possible to simultaneously identify HIV type 1 and 2, Hepatitis B (HBV), Syphilis, Hepatitis C (HCV), Human T-Lymphotropic Virus (HTLV type I and II), West Nile Virus (WNV), and many other blood-borne diseases. During this Phase I project, we have completed all tasks and successfully demonstrated the technical feasibility of simultaneous assay for multiple pathogens by fabricating 128-plex BMBs, integrating the analyzer, and performing HIV, HBV, and Syphilis multiplexed assays. The resulting combined technology is very powerful and will offer the following advantages: (1) Small quantity of sample: a few drops of blood in a microwell are all that's needed to identify multiple target pathogens. It not only determines a reactive sample, but also identifies "reactive to what" (2) Reduced window period: offers high sensitivity and specificity without the "window period" associated with antibody based screening technologies (3) Rapid and high throughput: the system can automatically process up to 100 samples per hour - for a maximum of 12,800 reportable results in a 96-microwell format (4) Flexibility: easy addition of new probes for additional screening targets on beads (5) Low cost, easy to use, and high reliability: BMB are low cost, simple operation steps, and batch to batch variation is minimal. In this Phase II project, we will focus on: (1) expand blood-borne pathogens panels from (3-plex to 8-plex) for Blood screening, (2) integrate the sample process with SAMP-B analyzer, and (3) develop and evaluate multiplex pathogens for blood screening.

抽象的 快速，高通量和高度准确地鉴定潜在的血液传播疾病将有助于血库快速测试大量捐赠的血液，并有助于防止进一步的感染。当前的血液测试有以下问题： 1。必须对所有疾病进行“一对一”的耗时测试和样本操作。 2。需要大的样本体积，取决于测试数量。 3。随着测试数量的增加，测试程序变得复杂。 4。必须由分子实验室中训练有素的人员运行的复杂操作程序。 最近使用核酸扩增测试技术（NAT）开发了商业上可用的测定法，使血液中心有可能考虑将这些测试应用于献血者筛查。但是，到目前为止，NAT测试系统是耗时的，而不是以“多路复用（> 2）方式”，因此不适合各种病原体对供体样品进行大规模筛选。 Maxwell Sensors，Inc。（MSI）建议将依赖性酶的放大和条形码磁珠（BMB）技术结合起来，以生成对血液中多种病原体（SAMP-B）的快速同时测定。 With a few drops of a donor's blood combined with digital magnetic beads in a single microwell, it is possible to simultaneously identify HIV type 1 and 2, Hepatitis B (HBV), Syphilis, Hepatitis C (HCV), Human T-Lymphotropic Virus (HTLV type I and II), West Nile Virus (WNV), and many other blood-borne diseases.在此阶段I项目中，我们已经完成了所有任务，并成功地证明了通过制造128个PLEX BMB，集成分析仪并执行HIV，HBV和梅毒多重测定的多种病原体的同时测定的技术可行性。由此产生的组合技术非常强大，将提供以下优势： （1）少量样品：鉴定多种靶病原体所需的全部需要几滴血液。它 不仅确定反应性样品，而且还标识了“反应性” （2）减少窗口时期：提供高灵敏度和特异性，而没有与基于抗体的筛选技术相关的“窗口周期” （3）快速和高吞吐量：系统可以自动处理每小时100个样品 - 最多可以96毫米格式获得12,800个可报告的结果 （4）灵活性：轻松添加新的探针以在珠子上进行其他筛选目标 （5）低成本，易于使用和高可靠性：BMB是低成本，简单的操作步骤，批次变化的批次是最小的。 在此II阶段项目中，我们将重点关注：（1）将血传播病原体面板从（3-质量到8 plex）扩展以进行血液筛查，（2）将样本过程与SAMP-B分析仪相结合，（3）开发和评估多重病原体进行血液筛查。