Point of Care Tests for Diagnosis of Sexually Transmitted Infections: A Landscape Analysis

Introduction: Sexually transmitted infections (STIs) cause morbidity and increase rates of acquisition and transmission of HIV infection. WHO estimated that almost 500 million new cases of the four most common curable bacterial STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum and Trichomonas vaginalis) occurred worldwide in 2008 among adults aged 15-49 years. Strategies for HIV and STI control include promotion of safe sexual behaviour, provision of condoms and early and efficacious management of STIs. STI diagnosis treatment in resource-limited settings relies on syndromic management leading to both under-treatment of asymptomatic infections and over-treatment of symptoms that mimic STIs. Point-of-care tests are potentially powerful contributors to STI management by allowing correct diagnosis and same day, directed treatment. Methods: To identify unmet needs and opportunities to catalyze innovation, a review of the status and rationale for new PoC STI diagnostics was conducted through stakeholder interviews. Results: Priorities identified for STI POC tests included ability to enable directed treatment at the time of presentation, decrease over-treatment and increase treatment of asymptomatic infections. Infections given the highest priority for development included chlamydia and gonococccal (GC) in women, detection of antimicrobial resistance in GC infections, tests for diagnosis of vaginal discharge and ability to distinguish new syphilis infection from prior, treated infection. Conclusion: There is potential for well-performing new tests to have an impact on STI epidemiology, however to attract interest, tests must be cost effective with existing STI management strategies.