Clinical trial of ALEX; a web based diagnostic service for bacterial infections

Purpose and goal

The project was conducted as a comparative clinical verification study between traditional diagnostic methods and the diagnostic software ALEX that identifies antibiotic resistance and outbreak tracing markers in raw data generated from whole genome sequenced Staphylococcus aureus DNA collected at Sahlgrenska. Aims that were accomplished: - Documentation of the analysis software diagnostic precision in clinical settings - Adaptation of the analytic software to the Ion torrent technique - Verification of the study protocol as a preparation for clinical CE registration studies

Expected results and effects

The study has given an overview of the Staphylococcus aureus antibiotic resistance situation and has clarified the transmission patterns in several patient clusters in the Gothenburg area. The study has therefore made it possible for the Sahlgrenska hospital to evaluate the technology readiness of ALEX for clinical diagnostic routine compared to methods already established at the hospital The result from the study will be used to support the required regulatory documentation for CEmark registration and be a part of the Health Technology Assessment that is a necessity for reimbursement processes.

Planned approach and implementation

The study was performed in collaboration with the Sahlgrenska hospital and include the whole analysis procedure from sample taking to result output, this in order to ensure the study protocol was optimized and that the diagnostics results from ALEX were of the highest quality.