This study compared standard of care testing (SOC) to BioFire® FilmArray® Pneumonia plus Panel (PNplus). PNplus detects 15 bacteria with semiquantitative log bin values, 7 antibiotic resistance markers, three atypical bacteria (AB), and eight viral classes directly from bronchoalveolar lavage-like specimens (BLS) and sputum-like specimens (SLS). Fifty-two laboratories from 13 European countries and Israel tested 1234 BLS and 1242 SLS with PNplus and SOC. Detection rates and number of pathogens/samples were compared for PNplus pathogens. PNplus bin values and SOC quantities were compared. Three thousand two hundred sixty-two bacteria in PNplus were detected by PNplus and/or SOC. SOC detected 57.1% compared to 95.8% for PNplus (p ≤ 0.0001). PNplus semiquantitative bin values were less than SOC, equal to SOC, or greater than SOC in 5.1%, 25.4%, and 69.6% of results, respectively. PNplus bin values were on average ≥ 1 log than SOC values (58.5% 1–2 logs; 11.0% 3–4 logs). PNplus identified 98.2% of MRSA and SOC 55.6%. SOC detected 73/103 AB (70.9%) and 134/631 viruses (21.2%). PNplus detected 93/103 AB (90.3%) and 618/631 viruses (97.9%) (p ≤ 0.0001). PNplus and SOC mean number of pathogens/samples were 1.99 and 1.44, respectively. All gram-negative resistance markers were detected. PNplus and SOC results were fully or partially concordant for 49.1% and 26.4% of specimens, respectively. PNplus was highly sensitive and detected more potential pneumonia pathogens than SOC. Semiquantification may assist in understanding pathogen significance. As PNplus generates results in approximately 1 h, PNplus has potential to direct antimicrobial therapy in near real time and improve antimicrobial stewardship and patient outcomes.

Background Classical methods to identify causes of community acquired, healthcare and ventilator associated pneumonia can be insensitive and slow, leading to unnecessary or inappropriate antimicrobial therapy. The BioFire® FilmArray® Pneumonia plus Panel (PNplus) detects 15 bacteria (in semi-quantitative log bin values from 10^4 to > 10^7), 7 antibiotic resistance markers (mecA/C/MREJ, CTX-M, KPC, VIM, IMP, NDM, OXA-48 like), 3 atypical bacteria (AB), and 8 viral classes directly from bronchoalveolar lavage (BAL)-like and sputum-like specimens (including endotracheal aspirates) in about 1 hr. This study compared PNplus results to standard of care testing (SOC). Methods 2476 samples (1234 BAL-like; 1242 sputum-like) were tested at 52 laboratories from 13 European countries and Israel by PNplus and SOC. SOC varied by site and physician prescription. Pathogen detection rates were compared. PNplus bin values and SOC descriptive or numerical quantities were evaluated for 1297 bacterial detections. Results 13 samples (0.5%) gave invalid PNplus results. 3278 bacteria in PNplus were detected by PNplus and/or SOC. SOC detected 1878 bacteria (57.1%) compared to 3128 bacteria (95.8%) for PNplus (p=< 0.0001). SOC detected 73 AB (70.9%) and 134 viruses (21.1%), PNplus detected 93 AB (90.3%) and 618 viruses (97.9%) (p=< 0.0001). Mean number of analytes/sample detected by PNplus and SOC were 1.99 and 1.44, respectively. PNplus bin values were less than SOC, equal to SOC or greater than SOC in 5.9%, 25.4% and 69.6% of results, respectively. PNplus values were on average > 1 log than SOC values (58.5% 1-2 logs; 11.0% 3-4 logs). PNplus identified 98.2% of MRSA and SOC 55.6%. All gram-negative resistance markers were detected at least once. PNplus and SOC results were fully concordant (positive or negative) or partially concordant for 49.1% and 26.4% of samples, respectively. Conclusion PNplus detected significantly more potential pathogens than SOC. Lack of routine SOC viral testing was a missed opportunity to define the cause of pneumonia. Semi-quantification may assist in understanding the significance of the pathogens detected. Pathogen and resistance marker detection in about 1 hr could dramatically impact antimicrobial use and enhance patient outcomes. Disclosures Christine C. Ginocchio, PhD, MT(ASCP), bioMerieux (Employee)bioMerieux (Employee, Shareholder) Barbara Mauerhofer, Pharmacist, bioMerieux (Employee) Cory Rindlisbacher, n/a, BioFire Diagnostics (Employee) Carolina Garcia, BS, bioMerieux (Employee)