Vastly improved influenza diagnostics through the development of a handheld thermal contrast reader

VIGILANT DIAGNOSTICS NIAID NIH STTR Phase I Application Vastly improved influenza diagnostics through the development of a portable thermal contrast reader PROJECT SUMMARY ABSTRACT Despite recent advances in rapid influenza diagnostic tests false negatives stemming from poor sensitivity contribute to nosocomial transmission and prevent thousands from receiving appropriate antiviral treatment Among vulnerable populations the consequences can be grave The population under five years of age experienced hospitalization rates of with influenza associated pediatric deaths during the influenza season and deaths in the pandemic Influenza associated hospitalization rates were for those years and for those over years We have developed a desktop system that uses a thermal contrast assay TCA reader to detect gold nanoparticles used in nearly all lateral flow assays LFAs for influenza With this TCA reader we have demonstrated an fold improvement in sensitivity over results from the industry leading handheld BD Veritor system in a flu A antigen dilution study We propose to begin commercializing this TCA reader technology by Building a prototype portable TCA reader that is functionally equivalent to the existing desktop TCA reader and Testing this prototype portable TCA reader alongside an existing visual flu LFA i e BD Veritor or other system the desktop TCA reader and polymerase chain reaction PCR testing in a clinical setting To build a prototype of the portable TCA reader we will first test and validate new and cheaper handheld components for functional equivalency with the corresponding fully characterized component in the desktop TCA reader We will then assemble the parts with a custom designed LFA holder into a functioning portable TCA reader Further we will work to develop proprietary Windows based software and algorithms for control of the prototype The prototype TCA reader will be tested on up to discarded influenza LFAs We will also compare to the corresponding nasopharyngeal samples that generated the LFAs to allow for correlative gold standard PCR testing The visual results of these LFAs will be known We will then test the visually negative LFAs with the portable TCR reader prototype After the corresponding nasopharyngeal swabs undergo PCR testing all results will be compared This portable TCA reader system will then be a prototype for a low cost high sensitivity easy to use point of care influenza diagnostic system that will reduce false negatives over today s industry leading handheld BD Veritor and other visual based flu LFAs VIGILANT DIAGNOSTICS NIAID NIH STTR Phase I Application Vastly improved influenza diagnostics through the development of a portable thermal contrast reader PROJECT NARRATIVE Early detection of influenza contributes to improved patient care reduced hospital admissions reduced transmission and better public health management Despite recent advances however the best early detection tests and reader for influenza on the market have low sensitivity roughly and thus a high rate of false negative results We propose to develop our innovative and highly effective thermal contrast amplification technology to build a low cost easy to use portable influenza detection system that will significantly reduce false negative results