Clinical evaluation of a new Ultra-Rapid Antibiotic Susceptibility Test in Blood Stream Infections

Purpose and goal

1) Production of Astrego’s disposable cartridges to be used for the aimed verification and implementation of design improvements: this objective has been fulfilled. 2) Verification of the Astrego® Technology for direct AST from blood culture bottles in a prospective clinical study: This objective was also achieved successfully. published in Medrxiv. 3) Preparation of the User Requirement Specifications (URS) for a diagnostic product utilizing the Astrego® technology to improve diagnostics of blood stream infections: This goal is achieved.

Expected results and effects

During the scope of this project we have performed 881 tests using various versions of Astrego´s prototypes. Findings from those tests helped us to evaluate the applicability of the technology to blood stream infections by assessing the performance tests results obtained in 30 minutes. The results were and published in MedRxiv (https://www.medrxiv.org/content/10.1101/2021.12.14.21267046v1). In addition Astrego received feedback from the users and improved the designs through prototypes.

Planned approach and implementation

Two prototype instruments (Astrego® technology) was installed at Karolinska University laboratory and evaluated with leftover positive blood culture samples from real patients using Astrego´s prototype AST Systems. Through the study, collaborating teams has met often in person or through teleconference to discuss the progress and share feedback to improve the systems being tested. Design of the prototypes have gone through multiple improvement rounds and some feedback that was not possible to accommodate during this study has been used for improvements beyond the study period.