Automated Near-Patient Molecular Diagnostics and Discrimination of Seasonal Infl

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DESCRIPTION (provided by applicant): We propose to perform analytical and clinical performance studies on a rapid point-of-care nucleic acid test for influenza virus based on IQuum's proprietary lab-in-a-tube (Liat") platform. We have developed the Liat" Influenza Assay, which detects and differentiates seasonal influenzas from potentially novel non- seasonal influenza A viruses using nasopharyngeal swab samples in less than 28 minutes. Utilizing the Liat" Analyzer, the Liat Influenza Assay automates all testing processes, including sample preparation, nucleic acid purification, reverse transcriptase polymerase chain reaction (RT-PCR), and real-time detection. The ease-of- use, bio-containment and fail-safe testing features of the Liat system will allow true point-of-care application. By determining the analytical and clinical performance of the first near-patient influenza nucleic acid test, this project will address the critical need for a sensitive, specific and rapid influenza assay that will enable any clinician or general healthcare practitioner to identify seasonal influenza strains, thus providing significant value to public health disease surveillance and control. In Phase I of this project, we seek to establish the analytical performance characteristics of the Liat Influenza Assay using viral strains similar to those found in clinical samples. In Phase II, we intend to further characterize and validate the assay in a multi-site clinical study. The outcome of this project will fulfill a key goal of influenza preparedness and provide the diagnostic tools need to safeguard public health. PUBLIC HEALTH RELEVANCE: The Liat" Influenza Assay will allow clinicians and general healthcare practitioner to detect and discriminate seasonal influenzas from potentially novel non-seasonal influenza A strains at critical near patient sites, such as emergency rooms, in less than 28 minutes. The assay will be among the first point-of-care nucleic acid tests, thus advancing the state of in vitro molecular diagnostics. By determining the analytical and clinical performance of the assay, this project will address the critical need for a rapid, sensitive, specific, and easy-to-use influenza assay, providing significant value to public health disease surveillance and control.