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

描述（由申请方提供）：MRSA和呼吸道病毒快速检测试剂盒用条形码磁珠。耐甲氧西林金黄色葡萄球菌（MRSA）对人类和经济的影响很大。MRSA现在占医院获得性S。美国的金黄色葡萄球菌感染（2004）。每年有超过278，000名住院患者感染MRSA。超过17，000例MRSA相关的住院治疗以死亡告终。超过25亿美元的额外医疗保健费用可归因于MRSA感染。疾病控制和预防中心（CDC）报告说，MRSA感染在过去六年中翻了一番。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接受医疗保险对许多医院获得性感染的报销。 2009年甲型H1N1流感，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病毒在美国通常没有流感的夏季继续导致疾病，住院和死亡，即将到来的流感季节可能会带来一些不确定性。由于该测试允许医生快速区分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。麦克斯韦传感器公司(MSI)成功地将条形码磁珠（BMB）（R）和目标富集多重聚合酶链反应（Tem-PCR）技术结合起来，用于简单、快速的多重检测，包括：14重呼吸道病毒病原体（RVP）（H1N1）检测板、18重MRSA检测板和12重HAI（医疗获得性感染）检测板。条形码磁珠提供了一种新的、简单的、稳健的多路复用平台，该平台可以用特定生物测定的特异性试剂包被，允许在均相测定中从样品中捕获和检测特定分析物。TEM-PCR是一种基于巢式靶特异性引物的新型扩增方法，允许对来自任何病原体和/或继发病原体的靶序列进行灵敏和特异性扩增。组合的BMB/Tem-PCR是一种非常强大的方法，适用于各种各样的面板应用。基于聚合物的BMB各自与一种特异性探针偶联，并且能够在单一均匀介质中准确地识别许多靶标。每个BMB使用特定的条形码来识别其特定的目标和用于目标检测的荧光测量。BMB的功能也类似于传统的磁珠，可用于常规洗涤过程和自动化。该技术非常强大，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病原体组;以及2.允许临床微生物实验室以及时、具有成本效益的方式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：实验室诊断学的当前发展的特征在于对免疫学或分子诊断学中的复杂参数谱的同时测定的日益增加的要求。与此同时，诊断实验室需要快速获得检测结果和降低总成本。从成本的角度来看，允许在单个生物样品中同时表征多个分子分析物的测试平台确实有意义。常规地，一个井被设计用于单个测试。现在，可以在一口井中进行多个测试。 由于降低医疗成本是国家的最大利益之一，因此拟议中的技术肯定可以通过一体化测试降低诊断费用。

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.