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This study compared standard of care testing (SOC) to BioFire® FilmArray® Pneumonia  plus  Panel (PN plus ). PN plus  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 PN plus  and SOC. Detection rates and number of pathogens/samples were compared for PN plus  pathogens. PN plus  bin values and SOC quantities were compared. Three thousand two hundred sixty-two bacteria in PN plus  were detected by PN plus  and/or SOC. SOC detected 57.1% compared to 95.8% for PN plus  ( p  ≤ 0.0001). PN plus  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. PN plus  bin values were on average ≥ 1 log than SOC values (58.5% 1–2 logs; 11.0% 3–4 logs). PN plus  identified 98.2% of MRSA and SOC 55.6%. SOC detected 73/103 AB (70.9%) and 134/631 viruses (21.2%). PN plus  detected 93/103 AB (90.3%) and 618/631 viruses (97.9%) ( p  ≤ 0.0001). PN plus  and SOC mean number of pathogens/samples were 1.99 and 1.44, respectively. All gram-negative resistance markers were detected. PN plus  and SOC results were fully or partially concordant for 49.1% and 26.4% of specimens, respectively. PN plus  was highly sensitive and detected more potential pneumonia pathogens than SOC. Semiquantification may assist in understanding pathogen significance. As PN plus  generates results in approximately 1 h, PN plus  has potential to direct antimicrobial therapy in near real time and improve antimicrobial stewardship and patient outcomes.   Supplementary Information  The online version contains supplementary material available at 10.1007/s10096-021-04195-5.

Multinational evaluation of the BioFire® FilmArray® Pneumonia plus Panel as compared to standard of care testing