Rapid molecular diagnostic for chlamydia and gonorrhea at the point-of-care

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 DESCRIPTION (provided by applicant): The scientific literature clearly shows that molecular testing, or detecting the DNA of the infecting organisms, is the most sensitive means of detecting the two most frequently occurring bacterial STIs: Chalmydia trachomatis (CT) and Neisseria gonorrhoeae (NG). CT is the most commonly reported bacterial infection in the United States. The CDC estimates that 3 million new cases of chlamydia and 700,000 cases of gonorrhea occur each year in the US. The annual global burden of new NG infections is estimated by the WHO to be 106 million. In the past 5 years, cases of antimicrobial resistant (AMR) NG have been reported and verified in Japan, Australia, several European countries, Canada and South Africa. There are no new antimicrobials for NG in the pharmaceutical pipeline, thus, we may be approaching a day when some NG is no longer treatable. The problem is likely more widespread worldwide, and the lack of sensitive and fast diagnostics in high burden countries are partly to blame. The United States CDC urges clinics to use POC tests if patients are unlikely to return to the clinic to learn the results of the test. Patients tat do not return for results are at a much higher risk for complications and transmission to others. For prenatal patients, a delay in diagnosis and treatment can endanger a fetus. Crucially, in global settings, patients who do not return are often not treated or treat themselves inappropriately using widely available "over the counter" antimicrobials. Clinicians without sensitive diagnostics in these settings will often treat based on symptomatic review, leading to overtreatment. In both cases, the march toward AMR is exacerbated. CT and NG often present simultaneously, which can complicate initial diagnosis of the identification of patients with unsuccessfully treated AMR NG. We propose an integrated sample-to-answer processing, amplification, and detection system for POC STI testing that results in simple and sensitive Yes/No visual readout for CT and NG on a hybrid paper/microfluidic chip. We have previously demonstrated on the bench-top, that each of these steps can be completed for simulated urine samples for both CT and NG in paper/microfluidic chips with minimal instrumentation. Our goal is to develop a portable, inexpensive molecular diagnostic device with minimal instrumentation that can be used at the POC to diagnose and differentiate CT and NG infections. The test will take less than one hour to perform and have and LOD for each organism of less than 1000 copies per sample.