Service de Bactériologie, Hôpital Cochin, AP-HP Centre, Université de Paris, Paris, France.
Laboratoire de bactériologie, CHU de Dijon, Dijon, France.
Clin Microbiol Infect. 2021 Sep;27(9):1308-1314. doi: 10.1016/j.cmi.2020.11.014. Epub 2020 Dec 1.
To evaluate performances of the rapid multiplex PCR assay BioFire FilmArray Pneumonia Panel (FA-PP) for detection of bacterial pathogens and antibiotic resistance genes in sputum, endotracheal aspirate (ETA) and bronchoalveolar lavage (BAL) specimens.
This prospective observational study was conducted in 11 French university hospitals (July to December 2018) and assessed performance of FA-PP by comparison with routine conventional methods.
A total of 515 respiratory specimens were studied, including 58 sputa, 217 ETA and 240 BAL. The FA-PP detected at least one pathogen in 384 specimens, yielding an overall positivity rate of 74.6% (384/515). Of them, 353 (68.5%) specimens were positive for typical bacteria while eight atypical bacteria and 42 resistance genes were found. While identifying most bacterial pathogens isolated by culture (374/396, 94.4%), the FA-PP detected 294 additional species in 37.7% (194/515) of specimens. The FA-PP demonstrated positive percentage agreement and negative percentage agreement values of 94.4% (95% CI 91.7%-96.5%) and 96.0% (95% CI 95.5%-96.4%), respectively, when compared with culture. Of FA-PP false-negative results, 67.6% (46/68) corresponded to bacterial species not included in the panel. At the same semi-quantification level (in DNA copies/mL for FA-PP versus in CFU/mL for culture), the concordance rate was 43.4% (142/327) for culture-positive specimens with FA-PP reporting higher semi-quantification of ≥1 log in 48.6% (159/327) of cases. Interestingly, 90.1% of detected bacteria with ≥10 DNA copies/mL grew significantly in culture.
FA-PP is a simple and rapid molecular test that could complement routine conventional methods for improvement of diagnosis accuracy of pneumonia.
评估快速多重 PCR 检测法 BioFire FilmArray 肺炎检测试剂盒（FA-PP）检测痰、气管内抽吸物（ETA）和支气管肺泡灌洗液（BAL）标本中细菌病原体和抗生素耐药基因的性能。
这项前瞻性观察性研究于 2018 年 7 月至 12 月在法国 11 所大学医院进行，通过与常规的常规方法比较来评估 FA-PP 的性能。
共研究了 515 份呼吸道标本，包括 58 份痰、217 份 ETA 和 240 份 BAL。FA-PP 在 384 份标本中至少检测到一种病原体，总体阳性率为 74.6%（384/515）。其中，353 份（68.5%）标本为典型细菌阳性，8 种非典型细菌和 42 种耐药基因阳性。FA-PP 能够鉴定出培养分离的大多数细菌病原体（374/396，94.4%），但在 37.7%（194/515）的标本中还检测到 294 种其他物种。FA-PP 与培养相比，阳性百分比符合率和阴性百分比符合率分别为 94.4%（95%CI 91.7%-96.5%）和 96.0%（95%CI 95.5%-96.4%）。当与培养相比时，FA-PP 的假阴性结果中，67.6%（46/68）对应于未包含在试剂盒中的细菌物种。在相同的半定量水平（FA-PP 为 DNA 拷贝/mL，培养为 CFU/mL）下，FA-PP 报告≥1 个对数级的半定量结果的培养阳性标本的符合率为 43.4%（142/327），其中 48.6%（159/327）的情况。有趣的是，≥10 DNA 拷贝/mL 的检测到的细菌中，90.1%在培养中显著生长。
FA-PP 是一种简单快速的分子检测方法，可以补充常规的常规方法，提高肺炎的诊断准确性。
