A-096 Evaluation of the all-in-one phenotypic AST BACTEROMIC® platform for the fast isolates and direct positive blood cultures

Abstract

Rising bacterial antimicrobial resistance is one of the major threats and challenges of current global healthcare. Estimating for approximately 1,27 million deaths a year and US$ 66 billion per year in health economic burden. One of the key tools in tackling antimicrobial resistance is efficient and accurate diagnostics. Rapid and accurate diagnosis is essential for guiding appropriate antimicrobial therapy and improving patient outcomes. BACTEROMIC is a novel diagnostic platform designed to determine phenotypic antimicrobial resistance both quantitatively and qualitatively. Utilising rapid equivalent of the gold standard method – broth microdilution, the assessment is based on determining minimum inhibitory concentration (MIC) and S-I-R classification. The system is designed to work with BACTEROMIC Panels (UNI 2.0. for standard isolate, UNI FAST for rapid isolate and PBC for direct AST from positive blood cultures). Presented study evaluated performance of Research Use Only (RUO) versions of two of the panels: UNI FAST and PBC against gold standard method – broth microdilution. Dataset for fast isolates (Panel UNI FAST RUO) consisted of 963 strains. Panel for fast direct AST from positive blood cultures (Panel PBC RUO) was tested on 329 strains. For both datasets, strains were selected from library of clinical isolates, including following species groups: Enterobacterales, Acinetobacter spp., Pseudomonas spp., Enterococcus spp., Staphylococcus spp. Performance of BACTEROMIC System was compared against the reference method broth microdilution. Key performance metrics included categorical agreement, essential agreement, bias, minor errors, major errors, very major errors, turnaround time. Across both datasets, BACTEROMIC System demonstrated high agreement with the reference method, with all the results presenting over 90% of essential agreement. Performance was consistent across both sample types and organisms. Notably, the system provided results in 6 to 8 hours for rapid protocols compared to minimum of 16 hours required for the standard method. These results confirm the robust performance of BACTEROMIC System in clinical isolate and direct positive blood culture testing. The technology has the potential not only to accelerate clinical decision-making, support antimicrobial stewardship, and improve patient outcomes but also become first all-in-one platform available on the market soon.