POCT for Sexually Transmitted Infections and its AMR

SD Biosensor’s STANDARD™ M10 system is an innovative molecular diagnostic platform designed for point-of-care use in decentralized settings. This project aims to develop and evaluate the M10 system’s performance using Real-time (RT)-PCR to detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and NG-Antimicrobial resistance (AMR). By providing rapid and accurate test results on-site, the STANDARD M10 system can enhance disease identification, particularly in cases with inconclusive clinical signs, thereby supporting informed medical decision-making. Key aspects of the project include generating analytical and clinical performance data for the RT-PCR-based CT/NG/NG-AMR cartridge, which will facilitate product registration with stringent regulatory authorities. The initiative will also involve pre-clinical validation and the establishment of a differentiated pricing strategy to ensure accessibility for various income levels. Ultimately, the successful implementation of this multiplex diagnostic technology aims to significantly improve the clinical management of STIs and AMR, both nationally and internationally.