Evaluating the effectiveness of FlashDx for diagnosing STIs among PrEP users in Kenya: A pilot study on diagnostic accuracy and prevalence. (Preprint)

BACKGROUND The global impact of sexually transmitted infections (STIs) significantly affects low- and middle-income countries (LMICs)In Kenya, where access to STI diagnostics is limited, effective diagnostic solutions are critically needed. The primary aim of this study is to validate the performance of FlashDx STI multiplex assay, in detecting STIs including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma Genitalium (MG), Mycoplasma Hominis (MH) and Ureaplasma Species (US) compared to the CE-IVD-D Golden Standard dual rtPCR of Mikrogen (CT and NG). OBJECTIVE Epidemiological data generated will include prevalence rates for all 6 STIs, providing an overview of STI prevalence with external validation to ensure accuracy and reliability. METHODS We propose to conduct a comparative cross-sectional study with up to 400 young PrEP users aged between 15 and 30 at the Kenya Medical Research Institute Center for Microbiology Research Research Care and Training Program research site in Kisumu Kenya. Urine samples will be collected and analyzed using the FlashDx STI multiplex chip-based assay to detect six STIs, with results confirmed by the CE-IVD-D certified Mikrogen assay in the Netherlands. RESULTS It is anticipated that the FlashDx STI multiplex assay will demonstrate high sensitivity and specificity in detecting CT and NG. The study will provide prevalence rates for all six STIs (CT, NG, TV, MG, USP and MH) offering a comprehensive overview of STI prevalence in this high-risk population CONCLUSIONS The findings from this study are expected to show the FlashDx STI multiplex assay as an effective POC system for diagnosing six common STIs in settings such as Kenya. By demonstrating its usability, accuracy, and reliability, the FlashDx assay could be considered for broader implementation in clinical settings across Kenya and other LMICs. This could significantly improve STI diagnosis and treatment, ultimately reducing the burden of STIs and their associated complications in these regions. In addition to providing insights into the prevalence of CT and NG, this study will also offer valuable estimates for other STIs relevant to female reproductive health. CLINICALTRIAL KEMRI Ethical approval registration: KEMRI/SERU/CMR/P00291/5102