In summary, only 56.6% of ICU patients receiving SAT had CP. Most strains were susceptible to SAT. A similar 28-day mortality rate was observed among groups; the late administration of SAT significantly worsened the prognosis of patients with less severe CP.

BackgroundVentilator-associated pneumonia (VAP) is one of the most commonly encountered hospital-acquired infections worldwide, and one of the major contributors to an over mortality in critically ill patients. Initial empirical antimicrobial therapy is often broad-spectrum. Fast identification and quantification of microorganisms is of great importance to enable early effective targeted antimicrobial treatment. This trial compares the performance of the new BioFire® Pneumonia Panel (BPP) with quantitative conventional culture (CC) and an independent real-time quantitative molecular-based method (MM), in Intensive Care Unit (ICU) patients with VAP suspicion.MethodsBronchoalveolar lavage (BAL) specimens from 120 patients with suspected VAP, enrolled at four different French ICUs, during January to November 2013, were analysed by CC, following microbiological standard procedures, by BPP and MM. A total of 15 bacterial targets, commonly detected by the three methods, were analysed for concordance above an agreed threshold for positivity. While every step is fully integrated, from specimen-to-results (BPP), bacterial DNA was extracted from each sample on the NucliSENS easyMAG® Platform, and real-time polymerase chain reactions were run in an ABI 7500 Dx thermocycler (MM).ResultsA total of 117 different BAL specimens were processed. Positive culture was obtained for 65.8% of BAL, while positive detections were observed in 79.4% with BPP and 75.4% with independent MM. Fourteen different species were detected by the three methods, with majority of the bacteria being S. aureus, P. aeruginosa, and H. influenzae. Overall concordance performance between BPP and CC was 89.0% (83.1%–94.9%) positive percentage agreement (PPA) and 95.9% (95.0%–96.9%) negative percentage agreement (NPA). Overall concordance between BPP and MM was 97.1% (93.8%–100.3%) PPA and 96.6% (95.6%–97.6%) NPA. Following discrepancy analyses overall performance increased to 95.3% (91.2–99.3%) PPA when comparing BPP to CC.ConclusionThe new BioFire® Pneumonia Panel provides reliable quantitative microbiological data in BAL specimens, in only 65 minutes, which can lead to more appropriate management of VAP suspected patients in the ICU.RUO products used in this study have not been evaluated by the FDA or other regulatory agencies for In Vitro Diagnostic use.Disclosures A. Iannello, bioMérieux: Employee, Salary. C. Dubost, bioMérieux: Employee, Salary. C. Weber, bioMérieux: Employee, Salary. C. Alberti-Segui, bioMérieux: Employee, Salary. C. Mousset, bioMérieux: Employee, Salary. C. Ginocchio, bioMérieux: Employee, Salary. M. Rogatcheva, BioFire: Employee, Salary. V. Moucadel, bioMérieux: Employee, Salary. J. Yugueros-Marcos, bioMérieux: Employee, Salary.

Background The BioFire Bone and Joint Infection (BJI) Panel is a sample-to-answer test for the qualitative detection of nearly 40 different bacteria, yeast, and antimicrobial resistance (AMR) genes in synovial fluid (SF). The panel aims to improve on current culture-based diagnostics, particularly for detection of anaerobes (e.g. Finegoldia magna, Kingella kingae, Cutibacterium, Anaerococcus and Peptoniphilus species, and others) in about an hour. Analytical performance of the panel (Limit of Detection (LoD), analytical reactivity and specificity, interference, reproducibility), and specimen storage conditions are described. Methods LoD for each analyte was estimated from serial dilutions and confirmed at the lowest titer with ≥95% detection. A collection of >350 isolates representing genetic and geographic diversity of analytes was tested near LoD to assess analytical reactivity, and more than 420 near-neighbor, commensal, pathogenic, or environmental off-panel species were evaluated for assay specificity. Reproducibility was evaluated in a multi-laboratory multi-variable study, and the impact of storage and potentially interfering substances on the accuracy of test results was also assessed. Testing was performed with Investigational Use Only kits. Results The confirmed LoD for bacteria and yeast ranged from 100 - 10,000 CFU/mL. Sequence analysis and testing demonstrated clinically appropriate specificity and reactivity with a variety of isolates and different AMR gene types. Accurate and reproducible organism and AMR gene detection was observed with repeated testing of samples over several days (99.9% agreement with the expected results), and detection was not affected by potentially interfering substances nor by refrigerated sample storage. Conclusion The BioFire BJI Panel is a robust, accurate, and easy-to-use multiplex PCR test capable of detecting many aerobic and anaerobic bacteria, yeast, and AMR genes in synovial fluid specimens. Rapid and reliable molecular detection of possible BJI pathogens may advance the diagnosis and effective management of bone and joint infections. Note This panel has not been evaluated by the FDA or other regulatory agencies for diagnostic use. Disclosures Nicholas Francis, n/a, BioFire Diagnostics (Employee) Laurence Barbier, n/a, Biomerieux (Employee) Caroline Dubost, n/a, Biomerieux (Employee) Elodie Billet, n/a, Biomerieux (Employee) Joel Manwaring, n/a, BioFire Diagnostics (Employee) Josh Southwick, n/a, BioFire Diagnostics (Employee) Tyson Dawson, n/a, BioFire Diagnostics (Employee) Jess Gann, n/a, BioFire Diagnostics (Employee) Kevin Ekins, n/a, BioFire Diagnostics (Employee) Jennifer Arce, MS, BioFire Diagnostics/BioMerieux (Employee) Briana Flaherty, n/a, BioFire Diagnostics (Employee) Harmonie Durand, n/a, Biomerieux (Employee) Chris Cantrell, n/a, Biomerieux (Employee) Elizabeth Amiott, n/a, BioFire Diagnostics (Employee)

BackgroundRapid diagnosis of causative agents of bloodstream infections improves patient outcomes and antibiotic stewardship. BioFire Diagnostics, LLC, is developing the BioFire® Blood Culture Identification 2 (BCID2) Panel, increasing the coverage of the BioFire® FilmArray® Blood Culture Identification (BCID) Panel for key pathogens and antimicrobial resistance (AMR) markers in aerobic and anaerobic positive blood culture (PBC). This revision expands the menu from 27 to 42 targets, with 26 bacterial (14 revised, six new) and seven fungal analytes (two revised, three new), as well as nine AMR markers (one revised, six new). Notable additions include the anaerobe Bacteroides fragilis, the emerging fungus Candida auris, and the mobile colistin resistance gene, mcr-1. This study details the reactivity and specificity of an RUO BioFire BCID2 panel.MethodsThe prototype was tested with fungal and bacterial isolates, some carrying AMR markers, at two sites by multiple operators. Reactivity was assessed at 106 CFU/mL for 301 analytes, and specificity at 108 CFU/mL for 43 on-panel and 93 off-panel strains. Evaluation included multiple strains for species level and AMR marker assays, as well as multiple species for family/genus level assays. Concordance with standard of care (SoC) results was examined for 126 archived PBC.ResultsTesting against 136 on-panel organisms, phylogenetic-neighbors, and normal cutaneous flora, showed 100% specificity for 41/42 targets. Reactivity was confirmed for 346/351 target analytes, and comprehensive detection was observed for the revised family-level Enteric assay (90/90) and genus-level Staphylococcus spp. (51/51), Streptococcus spp. (17/17), and Candida spp. (67/71) assays. The prototype showed excellent sensitivity (97.1%) and specificity (99.7%) compared with SoC with archived PBC.ConclusionPerformance of this RUO BioFire BCID2 Panel indicates that many key pathogens implicated in bloodstream infections can be identified with high sensitivity and specificity, and highlights the utility of the expanded menu to provide actionable information. Future panel versions will address observed deficiencies.RUO products used in this study have not been evaluated by the FDA or other regulatory agencies for In Vitro Diagnostic use.Disclosures J. Antosch, BioFire Diagnostics, LLC: Employee, Salary. U. Spaulding, BioFire Diagnostics, LLC: Employee, Salary. J. Stone, BioFire Diagnostics, LLC: Employee, Salary. C. Later, BioFire Diagnostics, LLC: Employee, Salary. K. Koch, BioFire Diagnostics, LLC: Employee, Salary. I. Kavetska, BioFire Diagnostics, LLC: Employee, Salary. H. Ton, BioFire Diagnostics, LLC: Employee, Salary. C. Alberti-Segui, bioMérieux: Employee, Salary. A. Grange, bioMereiux, Inc.: Employee, Salary. C. Dubost, bioMérieux: Employee, Salary. M. Rogatcheva, BioFire: Employee, Salary.