Utility of smartDNA with Sputum Smears

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DESCRIPTION (provided by applicant): The diagnosis of tuberculosis (TB) is a major weak link in global TB control. Drug resistant TB compounds diagnosis and treatment challenges. The most widely used diagnostic test. Sputum smear microscopy, cannot detect multi drug or extensively drug resistant TB (MDR/XDR-TB) and sputum culture is costly, and depending on the method used, takes 4-8 weeks to obtain a result and up to 16 weeks to detect MDR/XDR- TB. Consequently, there is an urgent need for a simple, rapid diagnostic test to identify the presence of Mycobacterium tuberculosis (MTB) and make a first line assessment of common drug resistance status that could be performed at the public health clinic while the patient waits. Investigen's long term objective is to develop rapid, sensitive, easy to use, POC diagnostic assays (smartDNA" based assays). Investigen's "smartDNATM technology" enables DNA detection to occur rapidly at room temperature in a homogeneous solution with colorimetric readout. There are two specific aims of this proposal. (1) Determine the feasibility of using material from a stained sputum smear slide in smartDNA assays, and (2) Determine the feasibility of discriminating a mutant drug resistance allele from a wild-type allele in post sputum smear samples with the smartDNA activator/reader. Success on this project could provide a diagnostic method and solve a critical barrier in TB control. PUBLIC HEALTH RELEVANCE: While the United States has been largely successful in detecting, treating and controlling TB, in many countries TB, MDR-TB and XDR-TB are a serious and growing public health issue; international travel and immigration have increased TB transmission. The research to be completed by this project is anticipated to lead to the development of a TB, MDR-TB and XDR-TB screening system that will provide results while the patient waits and can be used in resource constrained settings throughout the world, in clinics and emergency rooms in the United States and potentially even at US borders - greatly aiding public health services in the detection, treatment and control of TB, MDR-TB and XDR-TB.