648. BioFire® FilmArray® Pneumonia plus Panel Performance Evaluation: A Multicenter, International Collaborative Study

Abstract

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)

Identification of bacterial co-detections in COVID-19 critically Ill patients by BioFire® FilmArray® pneumonia panel: a systematic review and meta-analysis

“…A recent study evaluating the diagnostic yield of the panel versus a pneumonia multi-test bundle determined the panel was twice as likely to yield determination of the bacterial etiology for community-acquired pneumonia (CAP) while costing $60 less per case for testing [Gilbert et al, 2020] . Moreover, in a multinational evaluation among 52 laboratories, the BioFire PN plus was associated with a 20% increase in detections of one of more pathogens per specimen compared to standard of care testing [Ginocchio et al, 2020] . The increase in diagnostic yield is likely multifactorial.…”

“…However, the BioFire PN/PN plus may assist in this adjudication of infection vs colonization through semi-quantitative results. Several studies have examined the utility of using the panel's semi-quantitative values to assist in the differentiation of bacterial colonization versus infection [ Ginocchio et al, 2020 , Buchan et al, 2020 , Lee et al, 2019 , Yoo et al, 2020 , Edin et al, 2020 ]. Interpretation can be variable depending on several factors, including patient population, type of pneumonia (e.g.…”

“…CAP versus ventilator associated pneumonia), sample type (sputum-like versus bronchoalveolar lavage-like), presence and amounts of other pathogens, WBC counts and adjunctive biomarkers. Although in general the panel's values tend to be one or more logs greater than conventional culture values, relative pathogen abundances can assist in determining pathogen significance similar to culture interpretation [ Ginocchio et al, 2020 , Buchan et al, 2020 , Lee et al, 2019 , Yoo et al, 2020 , Edin et al, 2020 ]. Thus, in conjunction with clinical judgment, the BioFire PN/PN plus can increase the diagnostic information available and rate of delivery to clinicians for earlier and more robust therapy decision making.…”