Low-Cost Instrument-free Point-of-Care Test for Chlamydia and Gonorrhea

Summary Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) cause over 3 million sexually transmitted infections (STI) annually in the U.S. The estimated global rates are ~131 million and 78 million, respectively. These rates have been increasing 6% to 18% over the last few years. Both are responsible for severe morbidity, including pelvic inflammatory disease, infertility, ectopic pregnancy, chronic pelvic pain, and preterm birth, with an annual cost of several billion dollars in the U.S. alone. Ct and Ng are treated empirically, relying on antibiotic treatment algorithms because diagnostics for Ct and Ng are not available at the point-of- care (POC). The inability to diagnose and treat at the POC means that many patients are lost to follow up, fueling the transmission of untreated or inappropriately treated STIs. This problem is exacerbated by the high rates of asymptomatic Ct and Ng infections (~10-50% for males and ~70-80% for females) among individuals who are unlikely to seek care. Current diagnostics rely on commercial nucleic acid (NA) amplification tests (NAAT) that are expensive and provide results in a day or days. Most patients are unwilling to wait more than 20-30 minutes for a result. Currently, there is no FDA approved CLIA-waived POC test for either Ct or Ng. Our team has been developing instrument-free POC tests for infectious pathogens that can utilize different sample types with our proprietary lysis buffer and microfluidic amplification assays with easy-to-read colorimetric results in lt30 minutes. No equipment, sample collection or detection kits, or technical expertise are required. Because Ct rectal infections now outnumber those in the urogenital tract among women, and continue to increase among men who have sex with men (MSM) as do Ng infections, there is an urgent need for a rapid POC test that can utilize these samples for Ct/Ng screening and also for test-of-cure since a single dose of an antibiotic that is used for urogenital infections is inadequate to treat rectal infections. Our aim therefore is to build on our POC test platform to further develop our lysis buffer and microfluidic assays to provide a rapid, disposable, sensitive and specific Ct/Ng POC test that can accommodate endocervical, vaginal, urethral, rectal and urine samples. The WHO global action plan to control STDs emphasizes “the development of affordable point-of-care STI diagnostics.” And the CDC stresses that, “Providers should make STD screening a standard part of medical care.” Our Ct/Ng POC diagnostic test will meet this urgent medical need by increasing early detection, informing treatment at the POC, and reducing infection rates, transmission, and sequelae with the capability for in-home use and deployment to every type of clinic, health station, emergency room and resource constrained setting in the world.