Rapid Point of Care Diagnostic Assay for Pandemic Influenza

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DESCRIPTION (provided by applicant): Project summary We propose to develop a Liat(tm) Avian Influenza Assay to enable the specific detection and differentiation of potential pandemic avian influenza A/H5, A/H7 and A/H9 in less than 25 minutes. We will also develop a high throughput Liat Workstation and upgrade our disposable manufacturing systems to meet the challenge of extremely high patient loads during pandemic influenza outbreaks. We will further determine analytical sensitivity and specificity of the assay using influenza viral strains. We will further develop plans for influenza biomarker surveillance and production ramp-up to ensure pandemic preparedness. The resulting Liat Avian Influenza Assay will not only provide the US with a high-throughput, flexible and point-of-care assay for quickly identifying and tracking potential human pandemic outbreaks of avian influenza, but offer a broad spectrum technology that may allow for rapid incorporation of emerging pandemic influenza strains. The simplicity and error free testing features of the Liat system may also qualify the Liat Avian Influenza Assay as the first CLIA-waived nucleic acid test, which represents a significant advancement in biological sample testing and clinical diagnostics. RELEVANCE (See instructions): The Liat Avian Influenza Assay will be the first nucleic acid test that will be capable of detecting and subtyping potentially pandemic avian influenza in emergency rooms or other near patient sites in less than 25 minutes. The assay will also be among the first point-of-care nucleic acid tests, thus advancing the state of in vitro molecular diagnostics. By addressing the critical need for a rapid, sensitive, specific, and easy-to-use influenza assay, this project will provide significant value to public health disease surveillance and control.