Barcoded Magnetic Beads for Rapid Tests of MRSA and Respiratory Viral Panels

用于快速检测 MRSA 和呼吸道病毒检测的条形码磁珠

• 批准号: 7926790
• 负责人: Gao Chen
• 金额: $ 280.3万
• 依托单位: MAXWELL SENSORS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2012-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926790
• 关键词: Accounting; Antiviral Therapy; Attention; Automation; Bacteria; Base Sequence; Binding; Biological; Biological Assay; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical Microbiology; Communicable Diseases; Complex; Country; Coupled; Detection; Development; Diagnostic; Disease; Disease Outbreaks; Drops; Economics; Figs - dietary; Fluorescence; Gene Targeting; Genetic Materials; Health Care Costs; Healthcare; Hospitalization; Hospitals; Human; Immunology; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Laboratories; Lead; Marketing; Measurement; Medicare; Methicillin Resistance; Methods; Microbiology; Microscope; Molecular; Molecular Genetics; Nosocomial Infections; Nucleic acid sequencing; Patients; Pattern; Performance; Persons; Physicians; Polymerase Chain Reaction; Polymers; Process; Production; Reaction; Reagent; Reporting; Reproducibility; Sampling; Scanning; Screening procedure; Seasons; Sensitivity and Specificity; Signal Transduction; Social Impacts; Specimen; Staging; Staphylococcus aureus; Structure; Symptoms; System; Technology; Test Result; Testing; Time; Tube; Uncertainty; United States; Viral; Virus; Work; base; cost; design; flu; interest; magnetic beads; medical schools; meetings; methicillin resistant Staphylococcus aureus; multiplex detection; novel; pandemic disease; pathogen; public health relevance; research and development; resistant strain; respiratory; scale up; sensor; success; swine flu

DESCRIPTION (provided by applicant): Barcoded Magnetic Beads for Rapid Tests of MRSA and Respiratory Viral Panels. The human and financial impact of Methicillin-resistant Staphylococcus aureus (MRSA) is high. MRSA now accounts for greater than 60% of hospital-acquired S. aureus infections in the United States (2004). Over 278,000 hospitalized persons are infected by MRSA annually. Over 17,000 MRSA-related hospitalizations end in death. Over $2.5 billion excess health care costs are attributable to MRSA infections. The Centers for Disease Control and Prevention (CDC) has reported that MRSA infections have doubled in the past six years. The ability to accurately identify these pathogens is important because, beginning in October 2008, hospitals across the country may no longer receive Medicare reimbursement for many hospital acquired infections. The 2009 Influenza A/H1N1, or "swine flu," pandemic occupied the time and attention of many. With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months, there is some uncertainty about what the upcoming flu season might bring. Since the test allows physicians to quickly differentiate H1N1 patients from those who have similar symptoms, infected patients can be provided proper antiviral therapy in a timely manner. A rapid confirmation of H1N1 patients can mitigate many of the negative economic and social impacts associated with infectious disease outbreaks. Maxwell Sensors Inc. (MSI) has successfully combined Barcoded Magnetic Bead (BMB)(R) and Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR) technologies for simple, rapid, multiplex tests including: 14-plex Respiratory Viral Pathogen (RVP) (H1N1) panel, 18-plex MRSA panel, and 12-plex HAI (Healthcare Acquired Infection) panel. Barcode Magnetic Beads offer a new, simple, and robust multiplexed platform that can be coated with a reagent specific to a particular bioassay, allowing the capture and detection of specific analytes from a sample in homogeneous assays. Tem- PCR, a novel amplification method based on nested target-specific primers, allows sensitive and specific amplification of target sequences from any disease agents and/or secondary disease agent. The combined BMB/Tem-PCR is a very powerful method for a wide variety of panel applications. The polymer-based BMB are each coupled with one specific probe, and are able to accurately identify many targets in a single homogeneous medium. Each BMB uses a specific barcode to identify its specific target and fluorescence measurement for target detection. The BMB also functions like a traditional magnetic bead which can be used in routine washing processes and automation. The technology is very powerful and offers the following advantages: 1. Permit identification of panel of pathogens that are impossible or difficult to culture in the clinical microbiology laboratory setting; and 2. Allow clinical microbiology laboratories to provide important diagnostic information to physicians in a timely, cost-effective manner for an early, effective management of infected patients. PUBLIC HEALTH RELEVANCE: Current developments in laboratory diagnostics are characterized by an increasing request for the simultaneous determination of complex parameter profiles in immunology or molecular diagnostics. At the same time, rapid availability of test results and low total costs are needed for diagnostic laboratories. Test platforms that allow the simultaneous characterization of multiple molecular analytes in a single biological sample really make sense from the cost point of view. Conventionally, one well is designed for a single test. Now, multiple tests can be performed in one well. As reducing the cost of healthcare is one of the nation's best interests, the proposed technology certainly can reduce the expense of diagnostics by all-in-one tests.

描述（由申请人提供）：针对MRSA和呼吸道病毒面板快速测试的条形码磁珠。耐甲氧西林金黄色葡萄球菌（MRSA）的人类和财务影响很高。现在，MRSA占美国医院获得的金黄色葡萄球菌感染的60％以上（2004年）。每年有278,000名住院医师被MRSA感染。超过17,000次与MRSA相关的住院治疗以死亡告终。超过25亿美元的超额医疗保健费用归因于MRSA感染。疾病控制与预防中心（CDC）报告说，在过去的六年中，MRSA感染增加了一倍。准确识别这些病原体的能力很重要，因为从2008年10月开始，全国各地的医院可能不再收到许多医院收到的感染的医疗保险报销。 2009年流感A/H1N1或“猪流感”大流行占据了许多人的时间和注意力。随着新的H1N1病毒在正常无流感的夏季继续引起疾病，住院和死亡，因此即将到来的流感季节可能带来什么不确定性。由于该测试允许医生快速将H1N1患者与患有类似症状的患者区分开，因此可以及时提供受感染的患者的适当抗病毒治疗。 H1N1患者的快速确认可以减轻与传染病暴发有关的许多负面经济和社会影响。 Maxwell Sensors Inc.（MSI）已成功合并了条形码磁珠（BMB）（R）和富含目标的多重多重聚合酶链反应（TEM-PCR）技术，用于简单，快速，多重测试，包括：14-质量呼吸道病毒病毒病原体（RVP）（RVP）（RVP）（H1N1），18- PLEX MRSA MRSA PANEL，IFFRAIRE，和12-- PLACERARE，和12-- PLACERARE，和12-- PLEACEX HADEC（HADECX）（和12--PLECLEX HADECX）（和12-- PLEACX HADECX HADEA）。条形码磁珠提供了一个新的，简单且可靠的多路复用平台，可以用特定于特定的生物测定的试剂涂覆，从而可以在均匀测定中捕获和检测样品中的特定分析物。 TempCR是一种基于嵌套靶标特异性引物的新型扩增方法，允许对任何疾病剂和/或二次疾病剂的敏感和特异性扩增。 BMB/TEM-PCR组合是多种面板应用的一种非常强大的方法。基于聚合物的BMB每个都与一个特定的探针结合，并能够准确地识别单个均匀培养基中的许多靶标。每个BMB都使用特定条形码来识别其特定目标和荧光测量以进行目标检测。 BMB还可以像传统的磁珠一样起作用，该磁珠可用于常规洗涤过程和自动化。该技术非常强大，并具有以下优势：1。允许鉴定在临床微生物学实验室环境中不可能或难以培养的病原体；和2。允许临床微生物学实验室及时，具有成本效益的方式向医生提供重要的诊断信息，以对受感染患者进行早期有效的治疗。 公共卫生相关性：实验室诊断的当前发展的特征是，在免疫学或分子诊断中同时确定复杂参数概况的要求越来越多。同时，诊断实验室需要快速可用测试结果和较低的总成本。从成本的角度来看，单个生物样品中多个分子分析物同时表征多个分子分析物的测试平台确实是有意义的。通常，一个井是为一次测试而设计的。现在，可以一井进行多个测试。 由于降低医疗保健成本是美国的最大利益之一，因此拟议的技术肯定可以通过多合一测试来减少诊断的费用。