Evaluation of the Performance of Novel Gram-Negative and Gram-Positive Sepsis Panels for the Rapid Diagnosis of Bloodstream Infections

Background/Objectives: Bloodstream infections (BSIs) are a global healthcare issue associated with high mortality rates. Rapid diagnosis is of importance for the early selection of targeted therapy to improve patient outcomes. The use of rapid molecular assays with positive blood culture (BC) allows the identification (ID) of pathogens and the most relevant resistance determinants (RDs) in a shorter turnaround time, compared to standard culture. In this study, the performances of a new syndromic panel to determine the IDs and RDs of Gram-negative (GN) and Gram-positive (GP) bacteria were investigated in comparison with a standard-of-care (SoC) workflow. Methods: Two hospitals processed residual positive BC samples from non-replicated patients using Molecular Mouse (MM) Sepsis panels (Alifax, Padova, Italy) for GP ID, GN ID and RD detection. Results were compared with an SOC workflow based on subculture, ID by MALDI-ToF mass spectrometry, phenotypic antibiogram, and real-time PCRs for RDs from isolated colonies. Results: A total of 140 and 136 residual positive BC samples were found to be valid for MM-ID and RD, respectively, yielding 76 GN and 76 GP species. Overall ID agreement at the species level was 136/152 (89%). RD agreement was 144/146 (99%). Regarding GN and GP species, ID agreement was 68/76 (89%) and 70/76 (92%), respectively. Conclusions: MM showed high sensitivity in RD detection; however, some discrepancies with results of the SoC workflow were observed, represented by reduced sensitivity for some species-specific IDs. Panel size and compact instrument dimension can be seen as the principal advantage of this modular molecular assay for the rapid detection of pathogens responsible for BSIs.