The overall goal of this Phase I SBIR proposal to prove the feasibility of developing a rapid (<20 minute), CLIA-waived, fully automated, molecular diagnostic technology for the multiplexed detection of two sexually transmitted infections (STIs). ?Chlamydia trachomatis (CT) and ?Neisseria gonorrhoeae (NG) infections are the number one and two most commonly reported bacterial STIs, with an estimated 131 million and 78 million new cases annually of CT and NG, respectively worldwide. These infections are curable with antibiotics, however no rapid, accurate diagnostic test is available to inform clinical treatment decisions during the patient visit. Untreated infections lead to serious sequelae including pelvic inflammatory disease (PID) and its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic pain. Furthermore, loss to follow-up is a significant problem with STI patients. Therefore, ?timely diagnosis using accurate diagnostics and early treatment is imperative?. Rapid, immunoassay based point-of-care (POC) tests for CT/NG fail to diagnose more than 50% of Chlamydia positive cases. Nucleic Acid Amplification Tests (NAATs) are the current gold standard for diagnosing CT/NG due to their high sensitivity and specificity. However the only FDA approved POC NAAT for CT/NG is expensive and takes more than 90 minutes for diagnosis. As such ?there is great need for an effective POC diagnostic test for CT/NG. ?Specific Aims: The Phase I deliverable of this project will be to validate a 20 minute POC NAAT for CT/NG in a clinical setting.
In Aim 1, room temperature stable lyophilized reagents will be implemented on the device.
In Aim 2, the sample-to-answer assay will be developed and validated for clinical samples. Finally in Aim 3, the POC test device for CT/NG will be evaluated by the clinician end-user, in an actual clinical setting, using freshly collected patient samples. With a projected cost-of-goods of under $5, our miniaturized molecular diagnostic device will address the need for affordable portable tests that enable accurate, detection and treatment of multiple STDs in lab-free, point of care settings.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are easily cured with antibiotics, however since most cases are asymptomatic, they often go undiagnosed and untreated. Untreated infections lead to serious sequelae including pelvic inflammatory disease (PID) and its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic pain. Timely diagnosis using effective point-of-care diagnostics and early treatment is necessary. We propose to develop a 20-minute, automated, multiplex nucleic acid amplification test for CT/NG to enable rapid testing and treatment of infected individuals in a single visit.