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）：用于快速检测 MRSA 和呼吸道病毒组的条形码磁珠。耐甲氧西林金黄色葡萄球菌 (MRSA) 对人类和经济造成的影响很大。目前，在美国，MRSA 占医院获得性金黄色葡萄球菌感染的 60% 以上（2004 年）。每年有超过 278,000 名住院患者感染 MRSA。超过 17,000 例 MRSA 相关住院患者最终死亡。 MRSA 感染导致超过 25 亿美元的超额医疗费用。美国疾病控制与预防中心 (CDC) 报告称，MRSA 感染在过去六年中增加了一倍。准确识别这些病原体的能力非常重要，因为从 2008 年 10 月开始，全国各地的医院可能不再获得许多医院获得性感染的医疗保险报销。 2009 年甲型 H1N1 流感（即“猪流感”）大流行占据了许多人的时间和注意力。在通常无流感的夏季，新型 H1N1 病毒继续在美国造成疾病、住院和死亡，因此即将到来的流感季节可能会带来一些不确定性。由于该测试可以让医生快速区分 H1N1 患者和具有类似症状的患者，因此可以及时为感染患者提供适当的抗病毒治疗。快速确认 H1N1 患者可以减轻与传染病爆发相关的许多负面经济和社会影响。 Maxwell Sensors Inc. (MSI) 成功结合了条形码磁珠 (BMB)(R) 和目标富集多重聚合酶链式反应 (Tem-PCR) 技术，可进行简单、快速的多重测试，包括： 14 重呼吸道病毒病原体 (RVP) (H1N1) 检测组、18 重 MRSA 检测组和 12 重 HAI（医疗保健获得性感染）检测组。条形码磁珠提供了一种新的、简单且强大的多重平台，可以涂有特定于特定生物测定的试剂，从而可以在均相测定中捕获和检测样品中的特定分析物。 Tem-PCR 是一种基于嵌套靶特异性引物的新型扩增方法，可以灵敏且特异性地扩增任何疾病因子和/或继发疾病因子的靶序列。组合的 BMB/Tem-PCR 是一种非常强大的方法，适用于各种面板应用。基于聚合物的 BMB 均与一个特定的探针结合，能够准确识别单一均质介质中的许多目标。每个 BMB 使用特定的条形码来识别其特定的目标，并使用荧光测量来进行目标检测。 BMB 的功能也类似于传统磁珠，可用于常规洗涤过程和自动化。该技术非常强大，并具有以下优点： 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一组病原体； 2. 允许临床微生物学实验室及时、经济高效地向医生提供重要的诊断信息，以便对感染患者进行早期、有效的管理。 公共卫生相关性：实验室诊断当前发展的特点是对免疫学或分子诊断中复杂参数谱的同时测定的要求不断增加。同时，诊断实验室需要快速提供测试结果并降低总成本。从成本角度来看，允许同时表征单个生物样品中多种分子分析物的测试平台确实很有意义。按照惯例，一口井是为单次测试而设计的。现在，可以在一口井中进行多项测试。 由于降低医疗保健成本是国家的最大利益之一，因此拟议的技术当然可以降低一体化测试的诊断费用。