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

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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.