SBIR Phase I: Ultra-sensitive Detection of Lipoarabinomannan (LAM) and Interferon-Gamma (IFN-g) as Biomarkers for Detection of Tuberculosis (TB)

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This SBIR Phase I project is intended to develop a noninvasive, ultra-sensitive moleculardetection system for Tuberculosis (TB). Although the prevalence of TB has diminished, it stillremains the second leading cause of death from an infectious disease. The latest global TB reportfrom the World Health Organization with data compiled from 205 countries put the figures at 1.5million fatalities and 9.6 million infections annually. The proposed technology uses the nano-Plasmonic Grating (P-GRAT) properties to enhance the detection signal of the TB biomarker bymore than 100X. This results in detecting concentrations in femto-gram/milliliter range resultingin early detection and treatment. The specificity, faster results, low cost/test and ease of use,makes this system a substantive innovation in the TB diagnostic market. The TB testing marketaccounts for $1.5 billion annually of which North America is the second largest in terms ofgenerated revenue due to the higher pricing for TB detection. The proposed technology willbenefit the patients with early diagnosis and provide the health care professionals with earlytreatment options. With all the advantages this technology has to offer, it is expected to gain asignificant share in the market place and generate a revenue stream.The main limitation of the immunoassays is their inability to detect extremely small fluorescencesignals that are associated with ultra-low concentrations of biomarkers. The proposed nano-Plasmonic Grating (P-GRAT) technology can overcome this limitation due to its exceptionallyefficient light coupling, reduced scattering, high signal-to-noise ratio and directionalexcitation/emission. As a result, a fluorescence enhancement of P-GRAT is 100X or highercompared to a glass substrates or polyurethane well plates. Such enhancements translate to ultrasensitivedetection and early diagnosis. Commercial immunoassays require hours to days toachieve pg/ml sensitivity. In comparison, P-GRAT can detect pg/mL range concentrations in lessthan three hours. P-GRAT utilizes a simplified design to exclude expensive optics like lasersources, high-magnification objective lenses and filter cubes. The use of 3-D printed parts tofabricate the system and use a smartphone as the detector further reduces the cost. We intend todevelop and commercialize a noninvasive, ultra-sensitive (fg/ml) molecular detection system forTuberculosis (TB). TB specific biomarkers Lipoarabinomannan (LAM) and Interferon gamma(IFN-g) will be detected in urine and saliva. P-GRAT is a platform technology and can easily beadapted for the ultra-sensitive detection and diagnosis of other diseases, such as Zika, Ebola,HIV and Cancer.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.